Study to Assess the Long-term Safety of Oral Lacosamide in Subjects With Partial-onset Seizures
Study Details
Study Description
Brief Summary
The purpose of this study is to allow eligible subjects from the parent study, SP925 [NCT00655551] to continue lacosamide and to obtain additional long-term safety data
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Detailed Description
A multicenter, open-label extension study to assess the long-term safety and tolerability of lacosamide as adjunctive therapy in subjects with partial-onset seizures who were previously enrolled in the SP925 study [NCT00655551] (intravenous lacosamide loading dose followed by approximately 1 week of oral lacosamide maintenance).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Lacosamide Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years) |
Drug: lacosamide
Subjects' dose of lacosamide may be increased or decreased as needed to maintain a subject's effective and tolerable dose during the study. Tablets are 50 mg or 100 mg each; Dose is 100 mg/day up to 800 mg/day administered twice daily throughout the study (up to 2 years).
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Subjects With at Least One Adverse Event During This Open-label Extension Study (Maximum Study Duration 2 Years) [2 years]
An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).
- Number of Subjects Who Withdrew From the Study Due to an Adverse Event (Maximum Study Duration 2 Years) [2 years]
An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).
Eligibility Criteria
Criteria
Inclusion Criteria:
- Eligible subjects who participated in SP925 [NCT00655551] for treatment of partial-onset seizures
Exclusion Criteria:
-
Receiving any study drug or experimental device other than lacosamide
-
Meets withdrawal criteria for parent study SP925 [NCT00655551]
-
Experiencing ongoing serious adverse event
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Phoenix | Arizona | United States | ||
| 2 | Baltimore | Maryland | United States | ||
| 3 | Chesterfield | Missouri | United States | ||
| 4 | Columbus | Ohio | United States | ||
| 5 | Philadelphia | Pennsylvania | United States | ||
| 6 | Dallas | Texas | United States | ||
| 7 | Charlottesville | Virginia | United States |
Sponsors and Collaborators
- UCB BIOSCIENCES, Inc.
Investigators
- Study Director: UCB Clinical Trial Call Center, +1 877 822 9493 (UCB)
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- SP0926
- 2014-004384-21
Study Results
Participant Flow
| Recruitment Details | The study started in April 2008 with enrollment occuring in the United States only. The study completed June 2010 |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Lacosamide |
|---|---|
| Arm/Group Description | Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years) |
| Period Title: Overall Study | |
| STARTED | 97 |
| COMPLETED | 69 |
| NOT COMPLETED | 28 |
Baseline Characteristics
| Arm/Group Title | Lacosamide |
|---|---|
| Arm/Group Description | Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years) |
| Overall Participants | 97 |
| Age (Count of Participants) | |
| <=18 years |
2
2.1%
|
| Between 18 and 65 years |
95
97.9%
|
| >=65 years |
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
38.8
(11.71)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
47
48.5%
|
| Male |
50
51.5%
|
| Region of Enrollment (participants) [Number] | |
| United States |
97
100%
|
Outcome Measures
| Title | Number of Subjects With at Least One Adverse Event During This Open-label Extension Study (Maximum Study Duration 2 Years) |
|---|---|
| Description | An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design). |
| Time Frame | 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| All 97 subjects enrolled are in the Safety Set (SS) and are included in this analysis |
| Arm/Group Title | Lacosamide |
|---|---|
| Arm/Group Description | Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years) |
| Measure Participants | 97 |
| Number [subjects] |
93
|
| Title | Number of Subjects Who Withdrew From the Study Due to an Adverse Event (Maximum Study Duration 2 Years) |
|---|---|
| Description | An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design). |
| Time Frame | 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| All 97 subjects enrolled are in the Safety Set (SS) and are included in this analysis |
| Arm/Group Title | Lacosamide |
|---|---|
| Arm/Group Description | Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years) |
| Measure Participants | 97 |
| Number [subjects] |
10
|
Adverse Events
| Time Frame | 2 years | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Lacosamide | |
| Arm/Group Description | Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years) | |
All Cause Mortality |
||
| Lacosamide | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Lacosamide | ||
| Affected / at Risk (%) | # Events | |
| Total | 10/97 (10.3%) | |
| Cardiac disorders | ||
| Arrhythmia supraventricular | 1/97 (1%) | 1 |
| Atrial fibrillation | 1/97 (1%) | 1 |
| General disorders | ||
| Chest pain | 1/97 (1%) | 1 |
| Drug interaction | 1/97 (1%) | 1 |
| Infections and infestations | ||
| Giardiasis | 1/97 (1%) | 1 |
| Pneumonia | 1/97 (1%) | 1 |
| Sepsis | 1/97 (1%) | 1 |
| Injury, poisoning and procedural complications | ||
| Post procedural bile leak | 1/97 (1%) | 1 |
| Nervous system disorders | ||
| Convulsion | 2/97 (2.1%) | 2 |
| Lethargy | 1/97 (1%) | 1 |
| Psychiatric disorders | ||
| Hallucination | 1/97 (1%) | 1 |
| Homicidal ideation | 1/97 (1%) | 1 |
| Paranoia | 1/97 (1%) | 1 |
| Depression suicidal | 1/97 (1%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Lacosamide | ||
| Affected / at Risk (%) | # Events | |
| Total | 88/97 (90.7%) | |
| Ear and labyrinth disorders | ||
| Tinnitus | 5/97 (5.2%) | 5 |
| Eye disorders | ||
| Diplopia | 17/97 (17.5%) | 18 |
| Vision blurred | 10/97 (10.3%) | 10 |
| Gastrointestinal disorders | ||
| Vomiting | 16/97 (16.5%) | 18 |
| Nausea | 13/97 (13.4%) | 14 |
| Diarrhoea | 12/97 (12.4%) | 13 |
| Constipation | 5/97 (5.2%) | 6 |
| General disorders | ||
| Fatigue | 12/97 (12.4%) | 12 |
| Chest pain | 8/97 (8.2%) | 9 |
| Irritability | 5/97 (5.2%) | 6 |
| Infections and infestations | ||
| Upper respiratory tract infection | 14/97 (14.4%) | 17 |
| Sinusitis | 8/97 (8.2%) | 11 |
| Urinary tract infection | 7/97 (7.2%) | 8 |
| Nasopharyngitis | 6/97 (6.2%) | 7 |
| Injury, poisoning and procedural complications | ||
| Contusion | 5/97 (5.2%) | 5 |
| Investigations | ||
| Weight increased | 6/97 (6.2%) | 6 |
| Nervous system disorders | ||
| Dizziness | 43/97 (44.3%) | 50 |
| Somnolence | 12/97 (12.4%) | 13 |
| Coordination abnormal | 11/97 (11.3%) | 13 |
| Headache | 11/97 (11.3%) | 11 |
| Balance disorder | 11/97 (11.3%) | 13 |
| Tremor | 8/97 (8.2%) | 10 |
| Memory impairment | 5/97 (5.2%) | 5 |
| Hypoaesthesia | 5/97 (5.2%) | 7 |
| Psychiatric disorders | ||
| Insomnia | 9/97 (9.3%) | 9 |
| Confusional state | 8/97 (8.2%) | 8 |
| Depression | 7/97 (7.2%) | 7 |
| Skin and subcutaneous tissue disorders | ||
| Rash | 5/97 (5.2%) | 5 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
UCB has > 60 days but <= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
Results Point of Contact
| Name/Title | UCB Clinical Trial Call Center |
|---|---|
| Organization | UCB, Inc |
| Phone | +1 877 822 9493 |
- SP0926
- 2014-004384-21