A Phase 4 interventional study of Lacosamide in Partial Epilepsies, sponsored by UCB Pharma. Completed at 32 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-21.
Sponsored by UCB Pharma · Phase 4, Interventional, and Treatment
To evaluate if a flexible dose escalation of lacosamide, up to the maximum approved dose of 400 mg/day, or to a clinically effective lower dose for an individual patient, improves the tolerability and safety of lacosamide (200 mg to 400 mg/d) as add-on treatment for patients with partial onset epilepsy.
Explanation of acronym: SELF = Safety Efficacy Lacosamide Flexibility
1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's enrollment of 100 is above the median of 50 across 1,205 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →UCB Pharma is the lead sponsor of 238 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Flexible dosing between 200mg/day and 400mg/day
Drug: Lacosamide
Lacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks. Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day. Taper phase if needed: 3 to 4 weeks
Also known as: Vimpat®
Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Study
Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the study. The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed.
Time frame: During the study ( up to 24 - 28 weeks)
Number of Subjects Prematurely Discontinuing Due to a TEAE During the Study
Number of subjects prematurely discontinuing due to a TEAE during the study. The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed.
Time frame: During the study (up to 24 - 28 weeks)
Percentage of Subjects Retained on Vimpat Through the End of the 24-week Treatment Period
The number of subjects continuing on Vimpat up to and including Visit 4 (Week 24) divided by the number of patients who took at least 1 dose of Vimpat multiplied by 100. The overall Treatment Period comprises of a 12-week Titration Phase and 12-week Maintenance Phase.
Time frame: End of Treatment Period (24-week)
This is a 24-week study, which enrolled 100 patients at 44 sites in France.
| Milestone | Lacosamide |
|---|---|
| Started | 100 |
| Completed | 74 |
| Not completed | 26 |
| Withdrew: Adverse event | 14 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Withdrawal by subject | 4 |
| Withdrew: Lack of efficacy | 2 |
| Withdrew: Other reasons for premature termination | 4 |
Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the study. The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed.
| subjects | Lacosamide |
|---|---|
| Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Study | 64 |
Number of subjects prematurely discontinuing due to a TEAE during the study. The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed.
| subjects | Lacosamide |
|---|---|
| Number of Subjects Prematurely Discontinuing Due to a TEAE During the Study | 14 |
The number of subjects continuing on Vimpat up to and including Visit 4 (Week 24) divided by the number of patients who took at least 1 dose of Vimpat multiplied by 100. The overall Treatment Period comprises of a 12-week Titration Phase and 12-week Maintenance Phase.
| percentage of subjects | Lacosamide |
|---|---|
| Percentage of Subjects Retained on Vimpat Through the End of the 24-week Treatment Period | 73 |
Collected over During the study (up to 24 - 28 weeks). The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lacosamide | — | 3/100 (3%) | 49/100 (49%) |
| Event | Lacosamide |
|---|---|
| DiplopiaEye disorders | 1/100 |
| NauseaGastrointestinal disorders | 1/100 |
| ComaNervous system disorders | 1/100 |
| DizzinessNervous system disorders | 1/100 |
| Gait disturbanceGeneral disorders | 1/100 |
| Partial seizures with secondary generalisationNervous system disorders | 1/100 |
| Status epilepticusNervous system disorders | 1/100 |
| Event | Lacosamide |
|---|---|
| DizzinessNervous system disorders | 42/100 |
| HeadacheNervous system disorders | 8/100 |
| AstheniaGeneral disorders | 5/100 |
| Age, Categorical(Participants) | Lacosamide |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 88 |
| >=65 years | 12 |
| Age, Continuous(years) | Lacosamide |
|---|---|
| Mean | 44.5 ± 16.22 |
| Sex: Female, Male(Participants) | Lacosamide |
|---|---|
| Female | 55 |
| Male | 45 |
| Region of Enrollment(participants) | Lacosamide |
|---|---|
| France | 100 |
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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