Epilepsy
Conditions
Brief summary
The main purpose of this trial is to determine safety and efficacy of Lacosamide under long term therapy.
Interventions
DRUGLacosamide
50 mg and 100 mg tablets up to 800 mg/day as twice 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
Age
16 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* diagnosis of Epilepsy * completion of double blind trial
Exclusion criteria
* taking other investigational drug than Lacosamide * meeting withdrawal criteria from double blind trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) During the Treatment Period (up to 5.5 Years) | During the Treatment Period (up to 5.5 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 5.5 Years) | During the Treatment Period (up to 5.5 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 5.5 Years) | During the Treatment Period (up to 5.5 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 5.5 Years) | Baseline, Treatment Period (up to 5.5 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 5.5 Years) | Treatment Period (up to 5.5 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
Australia, Croatia, Czechia, Finland, France, Germany, Hungary, Lithuania, Poland, Russia, Spain, Sweden, United Kingdom
Participant flow
Recruitment details
The study was started in December of 2004 with recruitment occurring in Australia, Croatia, Czech Republic, Finland, France, Germany, Hungary, Lithuania, Poland, Russia, Spain, Sweden, and the United Kingdom. The study had last patient last visit in August of 2010.
Pre-assignment details
Safety Set consists of all subjects who received at least 1 dose of Lacosamide.
Participants by arm
| Arm | Count |
|---|---|
| Lacosamide 50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing) | 376 |
| Total | 376 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 34 |
| Overall Study | Lack of Efficacy | 92 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Other: Drug available on license | 1 |
| Overall Study | Other: Investigator decision | 1 |
| Overall Study | Other: Request from sponsor | 1 |
| Overall Study | Other: Site discontinuing trials | 2 |
| Overall Study | Other: Subject became pregnant | 1 |
| Overall Study | Other: Subject cannot attend visits | 2 |
| Overall Study | Other: Subject interested in other AED | 1 |
| Overall Study | Other: Subject moved to another country | 1 |
| Overall Study | Other: Subject required surgery | 1 |
| Overall Study | Protocol Violation | 3 |
| Overall Study | Unsatisfactory compliance | 6 |
| Overall Study | Withdrawal by Subject | 66 |
Baseline characteristics
| Characteristic | Lacosamide |
|---|---|
| Age, Categorical <=18 years | 7 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 366 Participants |
| Age, Continuous | 37.8 years STANDARD_DEVIATION 11.53 |
| Region of Enrollment Australia | 31 participants |
| Region of Enrollment Croatia | 31 participants |
| Region of Enrollment Czech Republic | 50 participants |
| Region of Enrollment Finland | 16 participants |
| Region of Enrollment France | 10 participants |
| Region of Enrollment Germany | 35 participants |
| Region of Enrollment Hungary | 31 participants |
| Region of Enrollment Lithuania | 42 participants |
| Region of Enrollment Poland | 37 participants |
| Region of Enrollment Russian Federation | 31 participants |
| Region of Enrollment Spain | 26 participants |
| Region of Enrollment Sweden | 16 participants |
| Region of Enrollment United Kingdom | 20 participants |
| Sex: Female, Male Female | 169 Participants |
| Sex: Female, Male Male | 207 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 232 / 376 |
| serious Total, serious adverse events | 87 / 376 |
Outcome results
Primary
Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (up to 5.5 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 5.5 years)
Population: Of the 376 subjects who entered the study, 376 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 5.5 Years) | 33 Subjects |
Primary
Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (up to 5.5 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 5.5 years)
Population: Of the 376 subjects who entered the study, 376 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 5.5 Years) | 87 Subjects |
Primary
Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) During the Treatment Period (up to 5.5 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 5.5 years)
Population: Of the 376 subjects who entered the study, 376 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 Treatment-emergent Adverse Event (TEAE) During the Treatment Period (up to 5.5 Years) | 311 Subjects |
Secondary
Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 5.5 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, Treatment Period (up to 5.5 years)
Population: Of the 376 subjects who were enrolled/treated in the study, 376 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 SP774 study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lacosamide | Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 5.5 Years) | -49.9 Percentage change |
Secondary
Percentage of at Least 50% Responders During the Treatment Period (up to 5.5 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 5.5 years)
Population: Of the 376 subjects who were enrolled/treated in the study, 376 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 SP774 study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lacosamide | Percentage of at Least 50% Responders During the Treatment Period (up to 5.5 Years) | 50.0 Percentage of subjects |