Partial Epilepsies
Conditions
Brief summary
The purpose of this trial is to determine whether lacosamide is safe and effective for long-term use in patients with partial-seizures from epilepsy.
Interventions
DRUGlacosamide
50mg and 100mg tablets up to 800 mg/day as twice a day (BID) dosing throughout the trial
Sponsors
UCB Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Completion of parent clinical trial for treatment of partial seizures.
Exclusion criteria
* Receiving any study drug or experimental device other than lacosamide. * Meets withdrawal criteria for parent trial or experiencing ongoing serious adverse event.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting at Least 1 Treat-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years) | During the Treatment Period (up to 8 years) | Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment. |
| Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years) | During the Treatment Period (up to 8 years) | Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment. |
| Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (up to 8 Years) | During the Treatment Period (up to 8 years) | A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 8 Years) | Baseline, End of Treatment Period (up to 8 years) | Median percentage change is the median value with respect to the percent change from Baseline across the population of subjects. Percentage change is calculated as 100 times the difference of the seizure frequency for the treatment period and the Baseline seizure frequency divided by the baseline seizure frequency. Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency. |
| Percentage of at Least 50% Responders During the Treatment Period (up to 8 Years) | Treatment Period (up to 8 years) | At least 50 percent response is based on the percentage reduction in 28-day seizure frequency during the Treatment Period of the open-label extension relative to the Baseline Phase of the prior study. This endpoint reflects the percentage of subjects with at least 50% reduction (ie, at least 50% change) in 28-day partial onset seizure frequency |
Countries
Germany, Hungary, Lithuania, Poland, Sweden, Switzerland, United Kingdom, United States
Participant flow
Recruitment details
The study was started in August of 2001 with recruitment occurring in the United States, Germany, Hungary, Lithuania, Poland, Sweden, Switzerland, and the United Kingdom. The study had last patient last visit in February of 2010.
Participants by arm
| Arm | Count |
|---|---|
| Lacosamide 50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing) | 370 |
| Total | 370 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 43 |
| Overall Study | Adverse event (AE)/withdrew (WD) consent | 2 |
| Overall Study | AE/Other: prohibited drug required | 1 |
| Overall Study | Lack of Efficacy | 120 |
| Overall Study | Lack of efficacy (LoE)/adverse event | 3 |
| Overall Study | Lack of efficacy/withdrew consent | 1 |
| Overall Study | LoE/WD consent/Other: cannot make visits | 1 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Other: Health problems, not drug related | 1 |
| Overall Study | Other: Personal problems | 1 |
| Overall Study | Other: Site closed | 4 |
| Overall Study | Other: Subject became pregnant | 1 |
| Overall Study | Other: Subject incarcerated | 1 |
| Overall Study | Other: Subject moved from area | 2 |
| Overall Study | Other: Subject underwent surgery | 4 |
| Overall Study | Other: Subject went to rehab | 1 |
| Overall Study | Other: Unable to attend visits | 1 |
| Overall Study | Poor compliance/lost to follow-up | 1 |
| Overall Study | Protocol Violation | 3 |
| Overall Study | Unsatisfactory compliance | 11 |
| Overall Study | Withdrawal by Subject | 44 |
Baseline characteristics
| Characteristic | Lacosamide |
|---|---|
| Age, Categorical <=18 years | 3 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 364 Participants |
| Age, Continuous | 40.8 years STANDARD_DEVIATION 11.01 |
| Region of Enrollment Germany | 21 participants |
| Region of Enrollment Hungary | 13 participants |
| Region of Enrollment Lithuania | 46 participants |
| Region of Enrollment Poland | 4 participants |
| Region of Enrollment Sweden | 24 participants |
| Region of Enrollment Switzerland | 2 participants |
| Region of Enrollment United Kingdom | 12 participants |
| Region of Enrollment United States | 248 participants |
| Sex: Female, Male Female | 192 Participants |
| Sex: Female, Male Male | 178 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 307 / 370 |
| serious Total, serious adverse events | 125 / 370 |
Outcome results
Primary
Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years)
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Time frame: During the Treatment Period (up to 8 years)
Population: Of the 370 subjects who entered the study, 370 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lacosamide | Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years) | 47 subjects |
Primary
Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (up to 8 Years)
A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.
Time frame: During the Treatment Period (up to 8 years)
Population: Of the 370 subjects who entered the study, 370 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lacosamide | Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (up to 8 Years) | 125 subjects |
Primary
Number of Subjects Reporting at Least 1 Treat-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years)
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Time frame: During the Treatment Period (up to 8 years)
Population: Of the 370 subjects who entered the study, 370 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lacosamide | Number of Subjects Reporting at Least 1 Treat-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years) | 343 subjects |
Secondary
Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 8 Years)
Median percentage change is the median value with respect to the percent change from Baseline across the population of subjects. Percentage change is calculated as 100 times the difference of the seizure frequency for the treatment period and the Baseline seizure frequency divided by the baseline seizure frequency. Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency.
Time frame: Baseline, End of Treatment Period (up to 8 years)
Population: Of the 370 subjects who were enrolled/treated in the study, 369 are included in this summary based on the Full Analysis Set (FAS). FAS population: number of subjects treated with at least 1 post-baseline seizure diary day with available data during the SP615 study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lacosamide | Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 8 Years) | -50.8 percentage change |
Secondary
Percentage of at Least 50% Responders During the Treatment Period (up to 8 Years)
At least 50 percent response is based on the percentage reduction in 28-day seizure frequency during the Treatment Period of the open-label extension relative to the Baseline Phase of the prior study. This endpoint reflects the percentage of subjects with at least 50% reduction (ie, at least 50% change) in 28-day partial onset seizure frequency
Time frame: Treatment Period (up to 8 years)
Population: Of the 370 subjects who were enrolled/treated in the study, 369 are included in this summary based on the Full Analysis Set (FAS). FAS population: number of subjects treated with at least 1 post-baseline seizure diary day with available data during the SP615 study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lacosamide | Percentage of at Least 50% Responders During the Treatment Period (up to 8 Years) | 51.2 percentage of subjects |