Extension Study Of Long-Term Safety And Efficacy Of Pregabalin As Monotherapy (Lyrica) In Patients With Partial Seizures

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00596466
• Collaborator: (none)
• Enrollment: 75
• Locations: 44
• Arm: 1
• Duration (Months): 44
• Patients Per Site: 1.7
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This study will evaluate the long term safety and efficacy of pregabalin (Lyrica) when administered by itself (without any other anti-epileptic medication) to epilepsy patients for the treatment of partial seizures. This is an extension study to a previous clinical trial.

Condition or Disease	Intervention/Treatment	Phase
Epilepsy	Drug: pregabalin	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 75 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label Multicenter Extension Study To Determine Long Term Safety And Efficacy Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: pregabalin; pregabalin

Outcome Measures

Primary Outcome Measures

1. Seizure Frequency [Baseline up to Week 28]

2. Number of Participants With (All Causality) Adverse Events (AEs) and Serious Adverse Events (SAEs) [Baseline up to Week 28]

   Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category.

3. Number of Participants With Laboratory Test Values of Potential Clinical Importance [Baseline up to Week 28]

   Pre-defined criteria were established for each laboratory test (hematology, blood chemistry and urinalysis) to define the values that would be identified as of potential clinical importance.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Completed the previous protocol and wish to continue to receive pregabalin.

• Diagnosis of epilepsy with partial seizures

Exclusion Criteria:

• Early withdrawal from the previous protocol, an episode of status epliepticus, or primary generalized epilepsy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Phoenix	Arizona	United States	85003
2	Pfizer Investigational Site	Fayetteville	Arkansas	United States	72703
3	Pfizer Investigational Site	Fullerton	California	United States	92835
4	Pfizer Investigational Site	Long Beach	California	United States	90806
5	Pfizer Investigational Site	Modesto	California	United States	95355
6	Pfizer Investigational Site	Murrieta	California	United States	92562
7	Pfizer Investigational Site	Newport Beach	California	United States	92660
8	Pfizer Investigational Site	Temecula	California	United States	92591
9	Pfizer Investigational Site	Denver	Colorado	United States	80204
10	Pfizer Investigational Site	Jacksonville	Florida	United States	32209
11	Pfizer Investigational Site	Suwanee	Georgia	United States	30024
12	Pfizer Investigational Site	Danville	Indiana	United States	46122
13	Pfizer Investigational Site	Fort Wayne	Indiana	United States	46805
14	Pfizer Investigational Site	Kansas City	Kansas	United States	66160
15	Pfizer Investigational Site	Bowling Green	Kentucky	United States	42101
16	Pfizer Investigational Site	Lexington	Kentucky	United States	40536
17	Pfizer Investigational Site	Houma	Louisiana	United States	70363
18	Pfizer Investigational Site	Shreveport	Louisiana	United States	71105-5634
19	Pfizer Investigational Site	Pikesville	Maryland	United States	21208
20	Pfizer Investigational Site	Worcester	Massachusetts	United States	01608
21	Pfizer Investigational Site	Detroit	Michigan	United States	48202
22	Pfizer Investigational Site	Flowood	Mississippi	United States	39232
23	Pfizer Investigational Site	Great Falls	Montana	United States	59405
24	Pfizer Investigational Site	Charlotte	North Carolina	United States	28203
25	Pfizer Investigational Site	Charlotte	North Carolina	United States	28209
26	Pfizer Investigational Site	Columbus	Ohio	United States	43210
27	Pfizer Investigational Site	Oklahoma City	Oklahoma	United States	73112
28	Pfizer Investigational Site	Oklahoma City	Oklahoma	United States	73120
29	Pfizer Investigational Site	Dallas	Texas	United States	75230
30	Pfizer Investigational Site	Houston	Texas	United States	77074
31	Pfizer Investigational Site	Temple	Texas	United States	76508
32	Pfizer Investigational Site	Salt Lake City	Utah	United States	84107
33	Pfizer Investigational Site	West Jordan	Utah	United States	84088
34	Pfizer Investigational Site	Milwaukee	Wisconsin	United States	53226
35	Pfizer Investigational Site	Beroun		Czechia	266 01
36	Pfizer Investigational Site	Brno 2		Czechia	602 00
37	Pfizer Investigational Site	Litomysl		Czechia	570 14
38	Pfizer Investigational Site	New Territories		Hong Kong
39	Pfizer Investigational Site	Dnipropetrovsk		Ukraine	49005
40	Pfizer Investigational Site	Dnipropetrovsk		Ukraine	49115
41	Pfizer Investigational Site	Kharkiv		Ukraine	61018
42	Pfizer Investigational Site	Kharkiv		Ukraine	61068
43	Pfizer Investigational Site	Lugansk		Ukraine	91045
44	Pfizer Investigational Site	Odessa		Ukraine	65025

Sponsors and Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT00596466
• Other Study ID Numbers: A0081160
• First Posted: Jan 17, 2008
• Last Update Posted: Jan 26, 2021
• Last Verified: Aug 1, 2012

• Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: open-label; extension study; pregabalin; partial epilepsy
• Additional relevant MeSH terms: Epilepsy; Seizures; Pregabalin

Study Results

Participant Flow

Pre-assignment Detail	Participants were eligible for the current study A0081160 (NCT00596466) if they adequately responded to pregabalin treatment in protocol A0081047 (NCT00524030).

Arm/Group Title	Pregabalin
Arm/Group Description	Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment.
Period Title: Overall Study
STARTED	75
Enrolled, Treated	73
COMPLETED	58
NOT COMPLETED	17

Baseline Characteristics

Arm/Group Title	Pregabalin
Arm/Group Description	Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment.
Overall Participants	75
Age, Customized (Number) [Number]
18-44 years	48 64%
45-64 years	23 30.7%
Greater than or equal to (≥) 65 years	4 5.3%
Sex: Female, Male (Count of Participants)
Female	38 50.7%
Male	37 49.3%

Outcome Measures

1. Primary Outcome

Title	Seizure Frequency
Time Frame	Baseline up to Week 28

Outcome Measure Data

Analysis Population Description

Not analyzed; Per protocol, seizure frequency data for individual participants were collected and reviewed but no statistical inferences were conducted because there was no comparator agent for this study.

Arm/Group Title	Pregabalin
Arm/Group Description	Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment.
Measure Participants	0

2. Primary Outcome

Title	Number of Participants With (All Causality) Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description	Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category.
Time Frame	Baseline up to Week 28

Outcome Measure Data

Analysis Population Description

Safety analysis set population: all participants who received at least 1 dose of pregabalin.

Arm/Group Title	Pregabalin
Arm/Group Description	Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment.
Measure Participants	73
Non-serious AEs	30 40%
Serious AEs (SAEs)	3 4%

3. Primary Outcome

Title	Number of Participants With Laboratory Test Values of Potential Clinical Importance
Description	Pre-defined criteria were established for each laboratory test (hematology, blood chemistry and urinalysis) to define the values that would be identified as of potential clinical importance.
Time Frame	Baseline up to Week 28

Outcome Measure Data

Analysis Population Description

Safety analysis set population; Number of participants analyzed (N): participants with at least one observation of any given laboratory test while on study.

Arm/Group Title	Pregabalin
Arm/Group Description	Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment.
Measure Participants	72
Number [Participants]	17 22.7%

Adverse Events

Adverse Event Reporting Description	The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Arm/Group Title	Pregabalin
Arm/Group Description	Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment.
All Cause Mortality
	Pregabalin
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Pregabalin
	Affected / at Risk (%)	# Events
Total	3/73 (4.1%)
Injury, poisoning and procedural complications
Road traffic accident	1/73 (1.4%)
Nervous system disorders
Convulsion	2/73 (2.7%)
Transient ischaemic attack	1/73 (1.4%)
Other (Not Including Serious) Adverse Events
	Pregabalin
	Affected / at Risk (%)	# Events
Total	14/73 (19.2%)
Gastrointestinal disorders
Nausea	4/73 (5.5%)
Investigations
Weight increased	3/73 (4.1%)
Musculoskeletal and connective tissue disorders
Arthralgia	3/73 (4.1%)
Nervous system disorders
Convulsion	3/73 (4.1%)
Headache	4/73 (5.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.