Simulated Driving Performance, Daytime Sedation and Cognition in Healthy Volunteers Taking Gralise, Neurontin or Lyrica
Sponsor
Depomed (Industry)
Overall Status
Completed
CT.gov ID
NCT03179345
Collaborator
(none)
32
4
1.9
Study Details
Study Description
Brief Summary
Phase 4, double-blind, placebo-controlled, four treatment, four sequence crossover study comparing simulated driving performance, daytime sedation and cognition in healthy volunteers administered therapeutic doses of Gralise® (Treatment A), Neurontin® (Treatment B), Lyrica® (Treatment C) and placebo (Treatment D). All doses were administered under fed conditions.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
32 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Primary Purpose:
Other
Official Title:
A Phase 4, Double-Blind, Placebo-Controlled, Crossover Study Comparing Simulated Driving Performance, Daytime Sedation, and Cognition in Healthy Volunteers Taking Therapeutic Doses of Gralise®, Neurontin®, or Lyrica®
Actual Study Start Date
:
Sep 24, 2015
Actual Primary Completion Date
:
Nov 20, 2015
Actual Study Completion Date
:
Nov 20, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Gralise® (gabapentin) Gralise® 3 x 600 mg tablets (1800 mg total dose) administered once daily at 7:00 pm on Day 1 and Day 2 with one placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®. At other dosing times, treatment consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule. |
Drug: Gabapentin
Other Names:
|
| Active Comparator: Neurontin® (gabapentin) Neurontin® 1 x 600 mg film-coated tablet administered 3 times daily at 7:00 pm on Day 1, at 8:00 am, 2:00 pm and 8:00 pm on Day 2 and at 8:00 a.m. on Day 3. Each dose of Neurontin® was over-encapsulated and administered with 3 placebo tablets matching the appearance of Gralise®. |
Drug: Gabapentin
Other Names:
|
| Active Comparator: Lyrica® (pregabalin) Lyrica® 1 x 150 mg capsule administered 2 times daily at 7:00 pm on Day 1, at 8:00 am and 8:00 pm on Day 2 and at 8:00 a.m. on Day 3. Each dose of Lyrica® was over-encapsulated and administered with 3 placebo tablets matching the appearance of Gralise®. |
Drug: Pregabalin
Other Names:
|
| Placebo Comparator: Placebo (sugar pill) Each dose consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®. |
Other: Placebo
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in the "Standard Deviation of the Lateral Position" (SDLP) Measured on the Driving Simulator Between Gralise® and Neurontin® [Baseline and Hour 3 on Day 3]
SDLP (feet): This is a measurement of change from maintaining the normal driving position in the lane over time and / or distance.
Secondary Outcome Measures
- Change From Baseline in the "Standard Deviation of the Lateral Position" (SDLP) Measured on the Driving Simulator Between Gralise® and Lyrica® [Baseline and Hour 3 on Day 3]
SDLP (feet): This is a measurement of change from maintaining the normal driving position in the lane over time and / or distance.
- Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - Detection Task (DET) [Baseline and Hour 3 on Day 3]
Cogstate - Detection Task (DET) is a simple reaction time test of Psychomotor Function. Higher change from baseline means better performance.
- Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - Groton Maze Learning Test (GMLT). [Baseline and Hour 3 on Day 3]
Cogstate - The Groton Maze Learning test is a measure Executive Function. Total number of errors made while attempting to learn the same hidden pathway across the consecutive learning trials performed at a single assessment. Lower score means better performance. Higher change from baseline means better performance.
- Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - Identification Task (IDN). [Baseline and Hour 3 on Day 3]
Cogstate - Identification Task (IDN) assesses Attention. Score is speed of performance (mean of the log10 transformed reaction times for correct responses). Lower score (quicker speed) is better performance. Higher change from baseline means better performance.
- Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - International Shopping List Test (ISL) [Baseline and Hour 3 on Day 3]
Cogstate - International Shopping List (ISL) test is a measure of verbal learning and uses a well-validated list-learning paradigm. Total number of correct responses remembering the word list on three consecutive trials at a single assessment. Higher score is better performance. Higher change from baseline means better performance.
- Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - One Card Learning (OCLT). [Baseline and Hour 3 on Day 3]
Cogstate - The One Card Learning Test (OCLT) is a measure of visual learning and uses a well-validated pattern separation paradigm with playing card stimuli. Higher Score is better performance. Higher change from baseline means better performance.
- Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Karolinska Sleepiness Scale (KSS). [Baseline and Hour 3 on Day 3]
Scale: 1-9, 1=extremely alert, 9 = very sleepy, great effort to keep awake, fighting sleep
- Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). [Baseline and Hour 3 on Day 3]
Portland Neurotoxicity Scale (PNS) comprises 15 questions measured on a 10-point scale. [1=No problem, 2, 3, 4, 5=Often a problem, 6, 7, 8, 9, 10=Severe problem] in 16 categories. Each question was analyzed and is presented in the same way as the primary endpoints.
- Change From Baseline Between Gralise® and Neurontin® in the Driving Simulator - Standard Deviation of Vehicle Speed (SDVS). [Baseline and Hour 3 on Day 3]
Miles per Hour (mph)
- Change From Baseline Between Gralise® and Lyrica® in the Driving Simulator - Standard Deviation of Vehicle Speed (SDVS). [Baseline and Hour 3 on Day 3]
Miles per Hour (mph)
- To Compare the Relative Safety and Tolerability of Gralise®, Neurontin®, and Lyrica®. [Screening to 1 week after Period 4 discharge]
Number of subjects with Treatment-Emergent Adverse Events (TEAE) Number of subjects with Serious Adverse Event (SAE) Number of subjects discontinued due to Adverse Event (AE)
Eligibility Criteria
Criteria
Ages Eligible for Study:
40 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Between 40 and 80 years of age, inclusive.
-
Body weight > 50 kg and BMI between 18 and 32 kg/m2, inclusive.
-
Able to give informed consent.
-
Licensed, experienced driver who had driven at least 3 times a week for the past 3 years and had visual acuity adequate for driving, as assessed by the investigator or designee.
-
Able to complete a 1 hour simulated driving test and demonstrate satisfactory driving skills, as determined by the investigator or designee.
-
Karolinska Sleep Scale (KSS) score of <=5.
-
Other criteria apply.
Exclusion Criteria:
-
Known history of allergic reaction, hypersensitivity or clinically significant intolerance to gabapentin, pregabalin or any pharmaceutical materials, or any of the ingredients in the protocol-specified meals.
-
Pregnant or lactating or considered at risk of pregnancy.
-
Any medical condition or any laboratory abnormality or ECG abnormality that would, in the opinion of the investigator, contraindicate study participation.
-
Impaired liver function (e.g., alanine aminotransferase [ALT] ≥2 times the upper limit of normal [ULN] or bilirubin ≥2 times ULN), known active hepatic disease (e.g., hepatitis), or evidence of clinically significant liver disease or other condition affecting the liver that may suggest the potential for an increased susceptibility to hepatic toxicity with oral gabapentin or pregabalin exposure.
-
Any history of renal disease that, in the opinion of the investigator, would contraindicate study participation; or subject had significantly impaired renal function as evidenced by an estimated GFR of ≤ 80 ml/min/1.73m2.
-
History or evidence of a sleep disorder, including sleep apnea (obstructive, central or mixed), narcolepsy or primary insomnia.
-
Other criteria apply.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Depomed
Investigators
- Study Director: Head of R&D, Depomed
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Depomed
ClinicalTrials.gov Identifier:
NCT03179345
Other Study ID Numbers:
- GRAL-PX-8401
First Posted:
Jun 7, 2017
Last Update Posted:
Jun 1, 2020
Last Verified:
Apr 1, 2020
Keywords provided by Depomed
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | A total of 32 healthy subjects enrolled in this crossover study. Each subject was randomly assigned to 1 out of 4 treatment sequences. Abbreviations: Gral = Gralise®; Neur = Neurontin®; Lyr = Lyrica®; Plbo = Placebo. |
| Arm/Group Title | Gral First, Then Neur, Lyr, and Plbo | Neur First, Then Plbo, Gral, and Lyr | Lyr First, Then Gral, Plbo, and Neur | Plbo First, Then Lyr, Neur, and Gral |
|---|---|---|---|---|
| Arm/Group Description | Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2. Neurontin® (gabapentin) 1 x 600 mg film-coated tablet: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3. Lyrica® (pregabalin) 1 x 150 mg capsule: Dosed 2 times daily starting in the evening on Day 1, in the morning and evening on Day 2, and in the morning on Day 3. Placebo (sugar pill): Three (3) placebo tablets matching the appearance of Gralise® & 1 placebo capsule matching the over-encapsulation of doses of Neurontin® & Lyrica®. All treatments were administered following a meal. Each treatment period was separated by a 7-day washout interval. | Neurontin® (gabapentin) 1 x 600 mg film-coated tablet: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3. Placebo (sugar pill): Three (3) placebo tablets matching the appearance of Gralise® & 1 placebo capsule matching the over-encapsulation of doses of Neurontin® & Lyrica®. Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2. Lyrica® (pregabalin) 1 x 150 mg capsule: Dosed 2 times daily starting in the evening on Day 1, in the morning and evening on Day 2, and in the morning on Day 3. All treatments were administered following a meal. Each treatment period was separated by a 7-day washout interval. | Lyrica® (pregabalin) 1 x 150 mg capsule: Dosed 2 times daily starting in the evening on Day 1, in the morning and evening on Day 2, and in the morning on Day 3. Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2. Placebo (sugar pill): Three (3) placebo tablets matching the appearance of Gralise® & 1 placebo capsule matching the over-encapsulation of doses of Neurontin® & Lyrica®. Neurontin® (gabapentin) 1 x 600 mg film-coated tablet: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3. All treatments were administered following a meal. Each treatment period was separated by a 7-day washout interval. | Placebo (sugar pill): Three (3) placebo tablets matching the appearance of Gralise® & 1 placebo capsule matching the over-encapsulation of doses of Neurontin® & Lyrica®. Lyrica® (pregabalin) 1 x 150 mg capsule: Dosed 2 times daily starting in the evening on Day 1, in the morning and evening on Day 2, and in the morning on Day 3. Neurontin® (gabapentin) 1 x 600 mg film-coated tablet: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3. Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2. All treatments were administered following a meal. Each treatment period was separated by a 7-day washout interval. |
| Period Title: Overall Study | ||||
| STARTED | 8 | 8 | 8 | 8 |
| Received Gralise® | 8 | 7 | 7 | 6 |
| Received Neurontin® | 8 | 8 | 7 | 8 |
| Received Lyrica® | 8 | 7 | 8 | 8 |
| Received Placebo | 8 | 7 | 7 | 8 |
| COMPLETED | 8 | 7 | 7 | 6 |
| NOT COMPLETED | 0 | 1 | 1 | 2 |
Baseline Characteristics
| Arm/Group Title | Gral First, Then Neur, Lyr, and Plbo | Neur First, Then Plbo, Gral, and Lyr | Lyr First, Then Gral, Plbo, and Neur | Plbo First, Then Lyr, Neur, and Gral | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2. Neurontin® (gabapentin) 1 x 600 mg film-coated tablet: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3. Lyrica® (pregabalin) 1 x 150 mg capsule: Dosed 2 times daily starting in the evening on Day 1, in the morning and evening on Day 2, and in the morning on Day 3. Placebo (sugar pill): Three (3) placebo tablets matching the appearance of Gralise® & 1 placebo capsule matching the over-encapsulation of doses of Neurontin® & Lyrica®. All treatments were administered following a meal. Each treatment period was separated by a 7-day washout interval. | Neurontin® (gabapentin) 1 x 600 mg film-coated tablet: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3. Placebo (sugar pill): Three (3) placebo tablets matching the appearance of Gralise® & 1 placebo capsule matching the over-encapsulation of doses of Neurontin® & Lyrica®. Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2. Lyrica® (pregabalin) 1 x 150 mg capsule: Dosed 2 times daily starting in the evening on Day 1, in the morning and evening on Day 2, and in the morning on Day 3. All treatments were administered following a meal. Each treatment period was separated by a 7-day washout interval. | Lyrica® (pregabalin) 1 x 150 mg capsule: Dosed 2 times daily starting in the evening on Day 1, in the morning and evening on Day 2, and in the morning on Day 3. Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2. Placebo (sugar pill): Three (3) placebo tablets matching the appearance of Gralise® & 1 placebo capsule matching the over-encapsulation of doses of Neurontin® & Lyrica®. Neurontin® (gabapentin) 1 x 600 mg film-coated tablet: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3. All treatments were administered following a meal. Each treatment period was separated by a 7-day washout interval. | Placebo (sugar pill): Three (3) placebo tablets matching the appearance of Gralise® & 1 placebo capsule matching the over-encapsulation of doses of Neurontin® & Lyrica®. Lyrica® (pregabalin) 1 x 150 mg capsule: Dosed 2 times daily starting in the evening on Day 1, in the morning and evening on Day 2, and in the morning on Day 3. Neurontin® (gabapentin) 1 x 600 mg film-coated tablet: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3. Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2. All treatments were administered following a meal. Each treatment period was separated by a 7-day washout interval. | Total of all reporting groups |
| Overall Participants | 8 | 8 | 8 | 8 | 32 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
49.0
(5.32)
|
47.6
(5.29)
|
51.0
(9.35)
|
46.8
(4.06)
|
48.6
(6.23)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
1
12.5%
|
3
37.5%
|
3
37.5%
|
1
12.5%
|
8
25%
|
| Male |
7
87.5%
|
5
62.5%
|
5
62.5%
|
7
87.5%
|
24
75%
|
Outcome Measures
| Title | Change From Baseline in the "Standard Deviation of the Lateral Position" (SDLP) Measured on the Driving Simulator Between Gralise® and Neurontin® |
|---|---|
| Description | SDLP (feet): This is a measurement of change from maintaining the normal driving position in the lane over time and / or distance. |
| Time Frame | Baseline and Hour 3 on Day 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The above is the only Primary Outcome Measure (comparing the SDLP between Gralise® and Neurontin®). |
| Arm/Group Title | Gralise® (Gabapentin) | Neurontin® (Gabapentin) | Placebo |
|---|---|---|---|
| Arm/Group Description | Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2. | Neurontin® (gabapentin) 1 x 600 mg film-coated tablet: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3. | Each dose consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3. |
| Measure Participants | 28 | 31 | 30 |
| Least Squares Mean (Standard Error) [feet] |
0.255
(0.0781)
|
0.395
(0.0763)
|
0.135
(0.0770)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Neurontin® (Gabapentin) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0275 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within Sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.141 | |
| Confidence Interval |
(2-Sided) 95% -0.266 to -0.016 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0611 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 0.120 | |
| Confidence Interval |
(2-Sided) 95% -0.006 to 0.245 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
| Title | Change From Baseline in the "Standard Deviation of the Lateral Position" (SDLP) Measured on the Driving Simulator Between Gralise® and Lyrica® |
|---|---|
| Description | SDLP (feet): This is a measurement of change from maintaining the normal driving position in the lane over time and / or distance. |
| Time Frame | Baseline and Hour 3 on Day 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The above is a Secondary Outcome Measure (comparing the SDLP between Gralise® and Lyrica®). |
| Arm/Group Title | Gralise® (Gabapentin) | Lyrica® (Pregabalin) | Placebo |
|---|---|---|---|
| Arm/Group Description | Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2. | Lyrica® (pregabalin) 1 x 150 mg capsule: Dosed 2 times daily starting in the evening on Day 1, in the morning and evening on Day 2, and in the morning on Day 3. | Each dose consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3. |
| Measure Participants | 28 | 30 | 30 |
| Least Squares Mean (Standard Error) [feet] |
0.255
(0.0781)
|
0.356
(0.0770)
|
0.135
(0.0770)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Neurontin® (Gabapentin) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1103 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.102 | |
| Confidence Interval |
(2-Sided) 95% -0.227 to 0.024 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0611 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 0.120 | |
| Confidence Interval |
(2-Sided) 95% -0.006 to 0.245 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
| Title | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - Detection Task (DET) |
|---|---|
| Description | Cogstate - Detection Task (DET) is a simple reaction time test of Psychomotor Function. Higher change from baseline means better performance. |
| Time Frame | Baseline and Hour 3 on Day 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Gralise® (Gabapentin) | Neurontin® (Gabapentin) | Lyrica® (Pregabalin) | Placebo (Sugar Pill) |
|---|---|---|---|---|
| Arm/Group Description | Gralise® 3 x 600 mg tablets (1800 mg total dose) administered once daily at 7:00 pm on Day 1 and Day 2 with one placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®. At other dosing times, treatment consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule. Gabapentin | Neurontin® 1 x 600 mg film-coated tablet administered 3 times daily at 7:00 pm on Day 1, at 8:00 am, 2:00 pm and 8:00 pm on Day 2 and at 8:00 a.m. on Day 3. Each dose of Neurontin® was over-encapsulated and administered with 3 placebo tablets matching the appearance of Gralise®. Gabapentin | Lyrica® 1 x 150 mg capsule administered 2 times daily at 7:00 pm on Day 1, at 8:00 am and 8:00 pm on Day 2 and at 8:00 a.m. on Day 3. Each dose of Lyrica® was over-encapsulated and administered with 3 placebo tablets matching the appearance of Gralise®. Pregabalin | Each dose consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®. Placebo |
| Measure Participants | 28 | 31 | 30 | 30 |
| Least Squares Mean (Standard Error) [msec] |
0.00
(0.013)
|
0.00
(0.012)
|
-0.01
(0.012)
|
-0.00
(0.012)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Neurontin® (Gabapentin) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9946 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.00 | |
| Confidence Interval |
(2-Sided) 95% -0.02 to 0.02 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.01 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1673 |
| Comments | ||
| Method | ANCOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 0.02 | |
| Confidence Interval |
(2-Sided) 95% -0.01 to 0.04 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.0125 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo (Sugar Pill) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6208 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 0.01 | |
| Confidence Interval |
(2-Sided) 95% -0.02 to 0.03 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.0125 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
| Title | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - Groton Maze Learning Test (GMLT). |
|---|---|
| Description | Cogstate - The Groton Maze Learning test is a measure Executive Function. Total number of errors made while attempting to learn the same hidden pathway across the consecutive learning trials performed at a single assessment. Lower score means better performance. Higher change from baseline means better performance. |
| Time Frame | Baseline and Hour 3 on Day 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Gralise® (Gabapentin) | Neurontin® (Gabapentin) | Lyrica® (Pregabalin) | Placebo (Sugar Pill) |
|---|---|---|---|---|
| Arm/Group Description | Gralise® 3 x 600 mg tablets (1800 mg total dose) administered once daily at 7:00 pm on Day 1 and Day 2 with one placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®. At other dosing times, treatment consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule. Gabapentin | Neurontin® 1 x 600 mg film-coated tablet administered 3 times daily at 7:00 pm on Day 1, at 8:00 am, 2:00 pm and 8:00 pm on Day 2 and at 8:00 a.m. on Day 3. Each dose of Neurontin® was over-encapsulated and administered with 3 placebo tablets matching the appearance of Gralise®. Gabapentin | Lyrica® 1 x 150 mg capsule administered 2 times daily at 7:00 pm on Day 1, at 8:00 am and 8:00 pm on Day 2 and at 8:00 a.m. on Day 3. Each dose of Lyrica® was over-encapsulated and administered with 3 placebo tablets matching the appearance of Gralise®. Pregabalin | Each dose consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®. Placebo |
| Measure Participants | 28 | 31 | 30 | 30 |
| Least Squares Mean (Standard Error) [Number of errors on test] |
-0.40
(2.484)
|
-0.01
(2.385)
|
-0.64
(2.419)
|
3.32
(2.420)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Neurontin® (Gabapentin) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8799 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.40 | |
| Confidence Interval |
(2-Sided) 95% -5.59 to 4.80 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.60 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9277 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 0.24 | |
| Confidence Interval |
(2-Sided) 95% -4.97 to 5.45 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.61 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo (Sugar Pill) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1587 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -3.73 | |
| Confidence Interval |
(2-Sided) 95% -8.94 to 1.49 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
| Title | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - Identification Task (IDN). |
|---|---|
| Description | Cogstate - Identification Task (IDN) assesses Attention. Score is speed of performance (mean of the log10 transformed reaction times for correct responses). Lower score (quicker speed) is better performance. Higher change from baseline means better performance. |
| Time Frame | Baseline and Hour 3 on Day 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Gralise® (Gabapentin) | Neurontin® (Gabapentin) | Lyrica® (Pregabalin) | Placebo (Sugar Pill) |
|---|---|---|---|---|
| Arm/Group Description | Gralise® 3 x 600 mg tablets (1800 mg total dose) administered once daily at 7:00 pm on Day 1 and Day 2 with one placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®. At other dosing times, treatment consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule. Gabapentin | Neurontin® 1 x 600 mg film-coated tablet administered 3 times daily at 7:00 pm on Day 1, at 8:00 am, 2:00 pm and 8:00 pm on Day 2 and at 8:00 a.m. on Day 3. Each dose of Neurontin® was over-encapsulated and administered with 3 placebo tablets matching the appearance of Gralise®. Gabapentin | Lyrica® 1 x 150 mg capsule administered 2 times daily at 7:00 pm on Day 1, at 8:00 am and 8:00 pm on Day 2 and at 8:00 a.m. on Day 3. Each dose of Lyrica® was over-encapsulated and administered with 3 placebo tablets matching the appearance of Gralise®. Pregabalin | Each dose consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®. Placebo |
| Measure Participants | 28 | 31 | 30 | 30 |
| Least Squares Mean (Standard Error) [Score on Scale] |
-0.00
(0.000)
|
0.00
(0.000)
|
-0.00
(0.000)
|
0.01
(0.000)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Neurontin® (Gabapentin) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7111 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.00 | |
| Confidence Interval |
(2-Sided) 95% -0.03 to 0.02 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.0125 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9048 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.00 | |
| Confidence Interval |
(2-Sided) 95% -0.02 to 0.02 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.01 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo (Sugar Pill) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3262 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.01 | |
| Confidence Interval |
(2-Sided) 95% -0.03 to 0.01 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.01 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
| Title | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - International Shopping List Test (ISL) |
|---|---|
| Description | Cogstate - International Shopping List (ISL) test is a measure of verbal learning and uses a well-validated list-learning paradigm. Total number of correct responses remembering the word list on three consecutive trials at a single assessment. Higher score is better performance. Higher change from baseline means better performance. |
| Time Frame | Baseline and Hour 3 on Day 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Gralise® (Gabapentin) | Neurontin® (Gabapentin) | Lyrica® (Pregabalin) | Placebo (Sugar Pill) |
|---|---|---|---|---|
| Arm/Group Description | Gralise® 3 x 600 mg tablets (1800 mg total dose) administered once daily at 7:00 pm on Day 1 and Day 2 with one placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®. At other dosing times, treatment consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule. Gabapentin | Neurontin® 1 x 600 mg film-coated tablet administered 3 times daily at 7:00 pm on Day 1, at 8:00 am, 2:00 pm and 8:00 pm on Day 2 and at 8:00 a.m. on Day 3. Each dose of Neurontin® was over-encapsulated and administered with 3 placebo tablets matching the appearance of Gralise®. Gabapentin | Lyrica® 1 x 150 mg capsule administered 2 times daily at 7:00 pm on Day 1, at 8:00 am and 8:00 pm on Day 2 and at 8:00 a.m. on Day 3. Each dose of Lyrica® was over-encapsulated and administered with 3 placebo tablets matching the appearance of Gralise®. Pregabalin | Each dose consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®. Placebo |
| Measure Participants | 28 | 31 | 30 | 30 |
| Least Squares Mean (Standard Error) [Score on Scale] |
0.36
(0.684)
|
0.82
(0.648)
|
0.03
(0.660)
|
-0.01
(0.660)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Neurontin® (Gabapentin) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5950 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.46 | |
| Confidence Interval |
(2-Sided) 95% -2.18 to 1.26 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.860 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7057 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 0.33 | |
| Confidence Interval |
(2-Sided) 95% -1.40 to 2.06 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.865 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo (Sugar Pill) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6741 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 0.37 | |
| Confidence Interval |
(2-Sided) 95% -1.36 to 2.10 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.865 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
| Title | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - One Card Learning (OCLT). |
|---|---|
| Description | Cogstate - The One Card Learning Test (OCLT) is a measure of visual learning and uses a well-validated pattern separation paradigm with playing card stimuli. Higher Score is better performance. Higher change from baseline means better performance. |
| Time Frame | Baseline and Hour 3 on Day 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Gralise® (Gabapentin) | Neurontin® (Gabapentin) | Lyrica® (Pregabalin) | Placebo (Sugar Pill) |
|---|---|---|---|---|
| Arm/Group Description | Gralise® 3 x 600 mg tablets (1800 mg total dose) administered once daily at 7:00 pm on Day 1 and Day 2 with one placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®. At other dosing times, treatment consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule. Gabapentin | Neurontin® 1 x 600 mg film-coated tablet administered 3 times daily at 7:00 pm on Day 1, at 8:00 am, 2:00 pm and 8:00 pm on Day 2 and at 8:00 a.m. on Day 3. Each dose of Neurontin® was over-encapsulated and administered with 3 placebo tablets matching the appearance of Gralise®. Gabapentin | Lyrica® 1 x 150 mg capsule administered 2 times daily at 7:00 pm on Day 1, at 8:00 am and 8:00 pm on Day 2 and at 8:00 a.m. on Day 3. Each dose of Lyrica® was over-encapsulated and administered with 3 placebo tablets matching the appearance of Gralise®. Pregabalin | Each dose consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®. Placebo |
| Measure Participants | 28 | 31 | 30 | 30 |
| Least Squares Mean (Standard Error) [Score on Scale] |
0.02
(0.021)
|
0.06
(0.020)
|
0.00
(0.020)
|
0.03
(0.020)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Neurontin® (Gabapentin) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0070 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.05 | |
| Confidence Interval |
(2-Sided) 95% -0.08 to -0.01 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.0175 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5183 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 0.01 | |
| Confidence Interval |
(2-Sided) 95% -0.02 to 0.05 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.0175 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo (Sugar Pill) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5084 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.01 | |
| Confidence Interval |
(2-Sided) 95% -0.05 to 0.02 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.0175 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
| Title | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Karolinska Sleepiness Scale (KSS). |
|---|---|
| Description | Scale: 1-9, 1=extremely alert, 9 = very sleepy, great effort to keep awake, fighting sleep |
| Time Frame | Baseline and Hour 3 on Day 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Gralise® (Gabapentin) | Neurontin® (Gabapentin) | Lyrica® (Pregabalin) | Placebo (Sugar Pill) |
|---|---|---|---|---|
| Arm/Group Description | Gralise® 3 x 600 mg tablets (1800 mg total dose) administered once daily at 7:00 pm on Day 1 and Day 2 with one placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®. At other dosing times, treatment consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule. Gabapentin | Neurontin® 1 x 600 mg film-coated tablet administered 3 times daily at 7:00 pm on Day 1, at 8:00 am, 2:00 pm and 8:00 pm on Day 2 and at 8:00 a.m. on Day 3. Each dose of Neurontin® was over-encapsulated and administered with 3 placebo tablets matching the appearance of Gralise®. Gabapentin | Lyrica® 1 x 150 mg capsule administered 2 times daily at 7:00 pm on Day 1, at 8:00 am and 8:00 pm on Day 2 and at 8:00 a.m. on Day 3. Each dose of Lyrica® was over-encapsulated and administered with 3 placebo tablets matching the appearance of Gralise®. Pregabalin | Each dose consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®. Placebo |
| Measure Participants | 28 | 31 | 30 | 30 |
| Least Squares Mean (Standard Error) [units on a scale] |
.774
(.2985)
|
.264
(.2876)
|
.868
(.2913)
|
.264
(.2914)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Neurontin® (Gabapentin) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1026 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 0.510 | |
| Confidence Interval |
(2-Sided) 95% -0.104 to 1.124 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.307 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7634 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.094 | |
| Confidence Interval |
(2-Sided) 95% -0.711 to 0.523 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.309 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo (Sugar Pill) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1041 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 0.510 | |
| Confidence Interval |
(2-Sided) 95% -0.107 to 1.127 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.309 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
| Title | Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS). |
|---|---|
| Description | Portland Neurotoxicity Scale (PNS) comprises 15 questions measured on a 10-point scale. [1=No problem, 2, 3, 4, 5=Often a problem, 6, 7, 8, 9, 10=Severe problem] in 16 categories. Each question was analyzed and is presented in the same way as the primary endpoints. |
| Time Frame | Baseline and Hour 3 on Day 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set |
| Arm/Group Title | Gralise® (Gabapentin) | Neurontin® (Gabapentin) | Lyrica® (Pregabalin) | Placebo (Sugar Pill) |
|---|---|---|---|---|
| Arm/Group Description | Gralise® 3 x 600 mg tablets (1800 mg total dose) administered once daily at 7:00 pm on Day 1 and Day 2 with one placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®. At other dosing times, treatment consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule. Gabapentin | Neurontin® 1 x 600 mg film-coated tablet administered 3 times daily at 7:00 pm on Day 1, at 8:00 am, 2:00 pm and 8:00 pm on Day 2 and at 8:00 a.m. on Day 3. Each dose of Neurontin® was over-encapsulated and administered with 3 placebo tablets matching the appearance of Gralise®. Gabapentin | Lyrica® 1 x 150 mg capsule administered 2 times daily at 7:00 pm on Day 1, at 8:00 am and 8:00 pm on Day 2 and at 8:00 a.m. on Day 3. Each dose of Lyrica® was over-encapsulated and administered with 3 placebo tablets matching the appearance of Gralise®. Pregabalin | Each dose consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®. Placebo |
| Measure Participants | 31 | 31 | 31 | 31 |
| Vision (blurring, double vision) |
0.036
(0.1274)
|
0.322
(0.1235)
|
0.249
(0.1249)
|
0.115
(0.1249)
|
| Energy Level (get up and go) |
0.099
(0.1811)
|
0.256
(0.1743)
|
0.315
(0.1766)
|
0.331
(0.1766)
|
| Memory (ability to remember people, places, or thi |
0.077
(0.1498)
|
0.123
(0.1441)
|
0.125
(0.1460)
|
-0.041
(0.1460)
|
| Walking (balance) |
0.206
(0.1245)
|
0.327
(0.1187)
|
0.405
(0.1206)
|
0.107
(0.1206)
|
| Interest (in activities) |
0.046
(0.1174)
|
0.030
(0.1130)
|
0.096
(0.1145)
|
0.070
(0.1145)
|
| Coordination |
0.180
(0.1338)
|
0.392
(0.1289)
|
0.350
(0.1306)
|
0.218
(0.1306)
|
| Tremor (shakiness) |
-0.103
(0.0571)
|
0.037
(0.0555)
|
-0.031
(0.0556)
|
0.068
(0.0556)
|
| Concentration (ability to concentrate on a task) |
0.080
(0.1205)
|
0.164
(0.1148)
|
0.137
(0.1166)
|
0.182
(0.1166)
|
| Speech (slurring words) |
0.035
(0.0516)
|
0.133
(0.0493)
|
0.065
(0.0501)
|
0.103
(0.0501)
|
| Forgetfulness |
0.118
(0.1128)
|
0.227
(0.1083)
|
0.175
(0.1098)
|
0.079
(0.1099)
|
| Sleepiness (fatigue, sedation, tiredness) |
0.693
(0.2928)
|
0.635
(0.2802)
|
1.176
(0.2843)
|
0.541
(0.2844)
|
| Moodiness |
0.181
(0.1174)
|
0.163
(0.1144)
|
0.098
(0.1155)
|
0.100
(0.1155)
|
| Alertness |
0.297
(0.1854)
|
0.451
(0.1786)
|
0.607
(0.1809)
|
0.353
(0.1809)
|
| Attention Span |
0.020
(0.1115)
|
0.133
(0.1070)
|
0.146
(0.1085)
|
0.015
(0.1085)
|
| Motivation |
0.185
(0.1338)
|
0.232
(0.1294)
|
0.368
(0.1309)
|
0.271
(0.1309)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Neurontin® (Gabapentin) |
|---|---|---|
| Comments | Vision | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0177 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.286 | |
| Confidence Interval |
(2-Sided) 95% -0.521 to -0.051 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.12 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Neurontin® (Gabapentin) |
|---|---|---|
| Comments | Energy Level | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4120 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.157 | |
| Confidence Interval |
(2-Sided) 95% -0.536 to 0.222 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Neurontin® (Gabapentin) |
|---|---|---|
| Comments | Memory | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7724 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.046 | |
| Confidence Interval |
(2-Sided) 95% -0.362 to 0.270 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Neurontin® (Gabapentin) |
|---|---|---|
| Comments | Walking Balance | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4255 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.121 | |
| Confidence Interval |
(2-Sided) 95% -0.423 to 0.180 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.15 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Neurontin® (Gabapentin) |
|---|---|---|
| Comments | Interest in activities | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8925 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 0.017 | |
| Confidence Interval |
(2-Sided) 95% -0.229 to 0.262 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.12 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Neurontin® (Gabapentin) |
|---|---|---|
| Comments | Coordination | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1293 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.212 | |
| Confidence Interval |
(2-Sided) 95% -0.487 to 0.063 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.14 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Neurontin® (Gabapentin) |
|---|---|---|
| Comments | Tremor | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0304 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.140 | |
| Confidence Interval |
(2-Sided) 95% -0.266 to -0.014 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Neurontin® (Gabapentin) |
|---|---|---|
| Comments | Concentration | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5811 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.084 | |
| Confidence Interval |
(2-Sided) 95% -0.384 to 0.217 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.15 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Neurontin® (Gabapentin) |
|---|---|---|
| Comments | Speech | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1144 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.098 | |
| Confidence Interval |
(2-Sided) 95% -0.220 to 0.024 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Neurontin® (Gabapentin) |
|---|---|---|
| Comments | Forgetfulness | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3774 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.109 | |
| Confidence Interval |
(2-Sided) 95% -0.352 to 0.135 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.12 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Neurontin® (Gabapentin) |
|---|---|---|
| Comments | Sleepiness | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8658 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 0.057 | |
| Confidence Interval |
(2-Sided) 95% -0.613 to 0.727 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.34 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Neurontin® (Gabapentin) |
|---|---|---|
| Comments | Moodiness | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8543 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 0.018 | |
| Confidence Interval |
(2-Sided) 95% -0.179 to 0.216 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.10 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Neurontin® (Gabapentin) |
|---|---|---|
| Comments | Alertness | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4294 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.153 | |
| Confidence Interval |
(2-Sided) 95% -0.537 to 0.231 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Neurontin® (Gabapentin) |
|---|---|---|
| Comments | Attention Span | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3613 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.113 | |
| Confidence Interval |
(2-Sided) 95% -0.357 to 0.132 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.12 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Neurontin® (Gabapentin) |
|---|---|---|
| Comments | Motivation | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7201 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.047 | |
| Confidence Interval |
(2-Sided) 95% -0.305 to 0.212 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.13 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo |
|---|---|---|
| Comments | Vision | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0767 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.213 | |
| Confidence Interval |
(2-Sided) 95% -0.448 to 0.023 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.12 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo |
|---|---|---|
| Comments | Energy Level | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2618 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.216 | |
| Confidence Interval |
(2-Sided) 95% -0.597 to 0.165 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo |
|---|---|---|
| Comments | Memory | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7633 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.048 | |
| Confidence Interval |
(2-Sided) 95% -0.366 to 0.269 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 19
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo |
|---|---|---|
| Comments | Walking Balance | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1968 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.198 | |
| Confidence Interval |
(2-Sided) 95% -0.502 to 0.105 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.15 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 20
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo |
|---|---|---|
| Comments | Interest in Activities | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6891 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.050 | |
| Confidence Interval |
(2-Sided) 95% -0.296 to 0.197 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.12 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 21
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo |
|---|---|---|
| Comments | Coordination | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2229 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.171 | |
| Confidence Interval |
(2-Sided) 95% -0.447 to 0.106 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.14 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 22
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo |
|---|---|---|
| Comments | Tremor | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2591 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.072 | |
| Confidence Interval |
(2-Sided) 95% -0.197 to 0.054 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 23
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo |
|---|---|---|
| Comments | Concentration | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7099 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.057 | |
| Confidence Interval |
(2-Sided) 95% -0.359 to 0.246 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.15 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 24
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo |
|---|---|---|
| Comments | Speech | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6215 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.031 | |
| Confidence Interval |
(2-Sided) 95% -0.154 to 0.092 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 25
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo |
|---|---|---|
| Comments | Forgetfulness | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6422 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.057 | |
| Confidence Interval |
(2-Sided) 95% -0.302 to 0.187 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.12 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 26
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo |
|---|---|---|
| Comments | Sleepiness | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1574 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.483 | |
| Confidence Interval |
(2-Sided) 95% -1.157 to 0.190 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.34 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 27
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo |
|---|---|---|
| Comments | Moodiness | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4039 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 0.084 | |
| Confidence Interval |
(2-Sided) 95% -0.115 to 0.282 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.10 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 28
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo |
|---|---|---|
| Comments | Alertness | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1145 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.309 | |
| Confidence Interval |
(2-Sided) 95% -0.695 to 0.076 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 29
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo |
|---|---|---|
| Comments | Attention Span | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3083 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.127 | |
| Confidence Interval |
(2-Sided) 95% -0.372 to 0.119 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.12 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 30
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo |
|---|---|---|
| Comments | Motivation | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1638 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.183 | |
| Confidence Interval |
(2-Sided) 95% -0.443 to 0.0776 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.13 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 31
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo (Sugar Pill) |
|---|---|---|
| Comments | Vision | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5101 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.078 | |
| Confidence Interval |
(2-Sided) 95% -0.314 to 0.157 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.12 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 32
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo (Sugar Pill) |
|---|---|---|
| Comments | Energy Level | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2285 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.233 | |
| Confidence Interval |
(2-Sided) 95% -0.614 to 0.149 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 33
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo (Sugar Pill) |
|---|---|---|
| Comments | Memory | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4612 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 0.118 | |
| Confidence Interval |
(2-Sided) 95% -0.200 to 0.436 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 34
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo (Sugar Pill) |
|---|---|---|
| Comments | Walking Balance | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5190 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 0.099 | |
| Confidence Interval |
(2-Sided) 95% -0.205 to 0.402 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.15 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 35
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo (Sugar Pill) |
|---|---|---|
| Comments | Interest in Activities | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8479 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.024 | |
| Confidence Interval |
(2-Sided) 95% -0.271 to 0.223 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.12 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 36
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo (Sugar Pill) |
|---|---|---|
| Comments | Coordination | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7808 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.039 | |
| Confidence Interval |
(2-Sided) 95% -0.316 to 0.238 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.14 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 37
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo (Sugar Pill) |
|---|---|---|
| Comments | Tremor | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0083 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.171 | |
| Confidence Interval |
(2-Sided) 95% -0.296 to -0.045 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 38
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo (Sugar Pill) |
|---|---|---|
| Comments | Concentration | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5068 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.101 | |
| Confidence Interval |
(2-Sided) 95% -0.404 to 0.201 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.15 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 39
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo (Sugar Pill) |
|---|---|---|
| Comments | Speech | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2725 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.068 | |
| Confidence Interval |
(2-Sided) 95% -0.191 to 0.055 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 40
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo (Sugar Pill) |
|---|---|---|
| Comments | Forgetfulness | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7498 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 0.039 | |
| Confidence Interval |
(2-Sided) 95% -0.206 to 0.284 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.12 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 41
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo (Sugar Pill) |
|---|---|---|
| Comments | Sleepiness | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6554 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 0.152 | |
| Confidence Interval |
(2-Sided) 95% -0.522 to 0.826 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.34 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 42
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo (Sugar Pill) |
|---|---|---|
| Comments | Moodiness | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4143 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 0.082 | |
| Confidence Interval |
(2-Sided) 95% -0.116 to 0.280 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.10 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 43
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo (Sugar Pill) |
|---|---|---|
| Comments | Alertness | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7761 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.055 | |
| Confidence Interval |
(2-Sided) 95% -0.441 to 0.330 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 44
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo (Sugar Pill) |
|---|---|---|
| Comments | Attention Span | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9697 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 0.005 | |
| Confidence Interval |
(2-Sided) 95% -0.241 to 0.251 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.12 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 45
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo (Sugar Pill) |
|---|---|---|
| Comments | Motivation | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5118 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.086 | |
| Confidence Interval |
(2-Sided) 95% -0.346 to 0.174 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.13 |
|
| Estimation Comments | ||
| Other Statistical Analysis | SE of difference estimated by dividing width of 95% CI by 4. | |
| Title | Change From Baseline Between Gralise® and Neurontin® in the Driving Simulator - Standard Deviation of Vehicle Speed (SDVS). |
|---|---|
| Description | Miles per Hour (mph) |
| Time Frame | Baseline and Hour 3 on Day 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set |
| Arm/Group Title | Gralise® (Gabapentin) | Neurontin® (Gabapentin) | Placebo |
|---|---|---|---|
| Arm/Group Description | Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2. | Neurontin® (gabapentin) 1 x 600 mg film-coated tablet: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3. | Each dose consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3. |
| Measure Participants | 28 | 31 | 30 |
| Least Squares Mean (Standard Error) [mph] |
0.831
(0.4844)
|
0.947
(0.4648)
|
0.851
(0.4715)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Neurontin® (Gabapentin) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8293 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.116 | |
| Confidence Interval |
(2-Sided) 95% -1.178 to 0.947 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.53 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9705 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.020 | |
| Confidence Interval |
(2-Sided) 95% -1.089 to 1.049 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.53 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
| Title | Change From Baseline Between Gralise® and Lyrica® in the Driving Simulator - Standard Deviation of Vehicle Speed (SDVS). |
|---|---|
| Description | Miles per Hour (mph) |
| Time Frame | Baseline and Hour 3 on Day 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set |
| Arm/Group Title | Gralise® (Gabapentin) | Lyrica® (Pregabalin) | Placebo |
|---|---|---|---|
| Arm/Group Description | Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2. | Lyrica® (pregabalin) 1 x 150 mg capsule: Dosed 2 times daily starting in the evening on Day 1, in the morning and evening on Day 2, and in the morning on Day 3. | Each dose consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3. |
| Measure Participants | 28 | 30 | 30 |
| Least Squares Mean (Standard Error) [mph] |
0.831
(0.4844)
|
1.319
(0.4713)
|
0.851
(0.4715)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Neurontin® (Gabapentin) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3666 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.488 | |
| Confidence Interval |
(2-Sided) 95% -1.556 to 0.581 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.53 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Gralise® (Gabapentin), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9705 |
| Comments | ||
| Method | ANOVA | |
| Comments | Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.020 | |
| Confidence Interval |
(2-Sided) 95% -1.089 to 1.049 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.53 |
|
| Estimation Comments | SE of difference estimated by dividing width of 95% CI by 4. | |
| Title | To Compare the Relative Safety and Tolerability of Gralise®, Neurontin®, and Lyrica®. |
|---|---|
| Description | Number of subjects with Treatment-Emergent Adverse Events (TEAE) Number of subjects with Serious Adverse Event (SAE) Number of subjects discontinued due to Adverse Event (AE) |
| Time Frame | Screening to 1 week after Period 4 discharge |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Gralise® (Gabapentin) | Neurontin® (Gabapentin) | Lyrica® (Pregabalin) | Placebo (Sugar Pill) |
|---|---|---|---|---|
| Arm/Group Description | Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2. | Neurontin® (gabapentin) 1 x 600 mg film-coated tablet: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3. | Lyrica® (pregabalin) 1 x 150 mg capsule: Dosed 2 times daily starting in the evening on Day 1, in the morning and evening on Day 2, and in the morning on Day 3. | Placebo (sugar pill): Three (3) placebo tablets matching the appearance of Gralise® & 1 placebo capsule matching the over-encapsulation of doses of Neurontin® & Lyrica®. |
| Measure Participants | 28 | 31 | 31 | 30 |
| Subjects with TEAE |
6
75%
|
13
162.5%
|
16
200%
|
5
62.5%
|
| Subjects with SAE |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Subjects Discontinued due to AE |
0
0%
|
1
12.5%
|
1
12.5%
|
0
0%
|
Adverse Events
| Time Frame | 7 weeks | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Adverse Events were reported from the signed informed consent to 30 days after the last dose of study drug. | |||||||
| Arm/Group Title | Gralise® (Gabapentin) | Neurontin® (Gabapentin) | Lyrica® (Pregabalin) | Placebo (Sugar Pill) | ||||
| Arm/Group Description | Gralise® (gabapentin) 3 x 600 mg tablets (1800 mg total): Dosed once daily in the evening on Day 1 and Day 2. | Neurontin® (gabapentin) 1 x 600 mg film-coated tablet: Dosed 3 times daily starting in the evening on Day 1, in the morning, afternoon, and evening on Day 2, and in the morning on Day 3. | Lyrica® (pregabalin) 1 x 150 mg capsule: Dosed 2 times daily starting in the evening on Day 1, in the morning and evening on Day 2, and in the morning on Day 3. | Placebo (sugar pill): Three (3) placebo tablets matching the appearance of Gralise® & 1 placebo capsule matching the over-encapsulation of doses of Neurontin® & Lyrica®. | ||||
All Cause Mortality |
||||||||
| Gralise® (Gabapentin) | Neurontin® (Gabapentin) | Lyrica® (Pregabalin) | Placebo (Sugar Pill) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| Gralise® (Gabapentin) | Neurontin® (Gabapentin) | Lyrica® (Pregabalin) | Placebo (Sugar Pill) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/28 (0%) | 0/31 (0%) | 0/31 (0%) | 0/30 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Gralise® (Gabapentin) | Neurontin® (Gabapentin) | Lyrica® (Pregabalin) | Placebo (Sugar Pill) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/28 (21.4%) | 11/31 (35.5%) | 14/31 (45.2%) | 2/30 (6.7%) | ||||
| Nervous system disorders | ||||||||
| Somnolence | 3/28 (10.7%) | 7/31 (22.6%) | 4/31 (12.9%) | 1/30 (3.3%) | ||||
| Dizziness | 3/28 (10.7%) | 4/31 (12.9%) | 6/31 (19.4%) | 0/30 (0%) | ||||
| Headache | 1/28 (3.6%) | 0/31 (0%) | 5/31 (16.1%) | 1/30 (3.3%) | ||||
| Psychiatric disorders | ||||||||
| Euphoric mood | 1/28 (3.6%) | 2/31 (6.5%) | 3/31 (9.7%) | 0/30 (0%) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The PI agrees that sponsor shall have the right to the first publication of the study results which is intended to be a joint, multi-center publication. Following the first publication, the PI may publish study data or results, provided however PI submits the proposed publication to sponsor for review at least 60 days prior to the date of the proposed publication. Sponsor may remove any information that is considered confidential and / or proprietary other than study data.
Results Point of Contact
| Name/Title | Clinical Operations |
|---|---|
| Organization | Depomed |
| Phone | 510-744-8000 |
| clinicaltrials@depomed.com |
Responsible Party:
Depomed
ClinicalTrials.gov Identifier:
NCT03179345
Other Study ID Numbers:
- GRAL-PX-8401
First Posted:
Jun 7, 2017
Last Update Posted:
Jun 1, 2020
Last Verified:
Apr 1, 2020