Partial Epilepsies
Conditions
Keywords
Epilepsy treatment., Anti-epileptic drugs, Seizures
Brief summary
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
Interventions
DRUGLacosamide
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
Sponsors
UCB Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient has a diagnosis of partial-onset epilepsy with or without secondary generalization * Currently taking 1 to 3 concomitant marketed antiepileptic drugs * 18 years and older at study entry
Exclusion criteria
* Previous use of lacosamide * Hypersensitivity to any component of lacosamide * Patients with partial onset seizures not clearly identifiable * History of generalized epilepsy * History of status epilepticus within last 12 months * Uncountable seizures due to clustering within last 12 weeks * Non epileptic events, including pseudoseizures, conversion disorder that could be confused with seizures * History of drug or alcohol abuse * History of suicide attempt * Progressive cerebral disease * Concomitant treatment of felbamate * Prior or concomitant vigabatrin use * Under legal protection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Study | During the study ( up to 24 - 28 weeks) | 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. |
| Number of Subjects Prematurely Discontinuing Due to a TEAE During the Study | During the study (up to 24 - 28 weeks) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Retained on Vimpat Through the End of the 24-week Treatment Period | End of Treatment Period (24-week) | 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. |
Countries
France
Participant flow
Recruitment details
This is a 24-week study, which enrolled 100 patients at 44 sites in France.
Pre-assignment details
The study comprises a 12-week Titration Phase and a 12-week Maintenance Phase; both phases together are regarded as the 24-week Treatment Period. Participant Flow and Baseline Characteristics refer to the Safety Set (SS). The SS includes all subjects that received at least one dose of study medication.
Participants by arm
| Arm | Count |
|---|---|
| Lacosamide Flexible dosing between 200mg/day and 400mg/day
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 | 100 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 14 |
| Overall Study | Lack of Efficacy | 2 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Other reasons for premature termination | 4 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Lacosamide |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 12 Participants |
| Age, Categorical Between 18 and 65 years | 88 Participants |
| Age, Continuous | 44.5 years STANDARD_DEVIATION 16.22 |
| Region of Enrollment France | 100 participants |
| Sex: Female, Male Female | 55 Participants |
| Sex: Female, Male Male | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 49 / 100 |
| serious Total, serious adverse events | 3 / 100 |
Outcome results
Primary
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)
Population: Safety Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lacosamide | Number of Subjects Prematurely Discontinuing Due to a TEAE During the Study | 14 subjects |
Primary
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)
Population: Safety Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lacosamide | Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Study | 64 subjects |
Secondary
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)
Population: Safety Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lacosamide | Percentage of Subjects Retained on Vimpat Through the End of the 24-week Treatment Period | 73 percentage of subjects |