Partial Epilepsies
Conditions
Keywords
Adjunctive treatment in epilepsy, add-on treatment for epilepsy, partial seizures, AEDs, antiepileptic drugs, seizures
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 or 100 mg tablets, up to 800 mg/day given twice daily (BID) throughout the trial
Sponsors
UCB BIOSCIENCES, Inc.
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
* 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 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years) | During the Treatment Period (Maximum 6 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 (Maximum 6 Years) | During the Treatment Period (Maximum 6 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 (Maximum 6 Years) | During the Treatment Period (Maximum 6 years) | Serious adverse events are any untoward serious medical occurrences in a subject administered study treatment, whether or not these events are related to treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (Maximum 6 Years) | Baseline (8-week Baseline Period from the parent study SP0754 [NCT00136019]), Treatment Period (Maximum 6 years) | 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 (Maximum 6 Years) | Treatment Period (Maximum 6 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lacosamide Up to 800 mg/day lacosamide (flexible dosing) | 308 |
| Total | 308 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 35 |
| Overall Study | Lack of Efficacy | 80 |
| Overall Study | Lost to Follow-up | 8 |
| Overall Study | Other: Site / clinic closed | 4 |
| Overall Study | Other: Sponsor request | 2 |
| Overall Study | Other: Subject arrested | 1 |
| Overall Study | Other: Subject had surgery for epilepsy | 2 |
| Overall Study | Other: Subject is pregnant | 2 |
| Overall Study | Other: Subject ran out of medication | 1 |
| Overall Study | Other: Subject relocated | 2 |
| Overall Study | Other: Subject wants to become pregnant | 2 |
| Overall Study | Other: Travel to / from site difficulty | 3 |
| Overall Study | Protocol deviation | 1 |
| Overall Study | Subject withdrew consent | 16 |
| Overall Study | Unsatisfactory compliance | 11 |
Baseline characteristics
| Characteristic | Lacosamide |
|---|---|
| Age, Categorical <=18 years | 6 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 295 Participants |
| Age, Continuous | 38.2 years STANDARD_DEVIATION 12.46 |
| Region of Enrollment United States | 308 participants |
| Sex: Female, Male Female | 146 Participants |
| Sex: Female, Male Male | 162 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 265 / 308 |
| serious Total, serious adverse events | 71 / 308 |
Outcome results
Primary
Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 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 (Maximum 6 years)
Population: Of the 308 subjects who entered the study, 308 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 (Maximum 6 Years) | 33 subjects |
Primary
Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 6 Years)
Serious adverse events are any untoward serious medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Time frame: During the Treatment Period (Maximum 6 years)
Population: Of the 308 subjects who entered the study, 308 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 (Maximum 6 Years) | 71 subjects |
Primary
Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 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 (Maximum 6 years)
Population: Of the 308 subjects who entered the study, 308 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 (Maximum 6 Years) | 288 subjects |
Secondary
Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (Maximum 6 Years)
Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency.
Time frame: Baseline (8-week Baseline Period from the parent study SP0754 [NCT00136019]), Treatment Period (Maximum 6 years)
Population: Of the 308 subjects who were enrolled/treated in the study, 307 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 SP756 study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lacosamide | Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (Maximum 6 Years) | -48.5 percentage change |
Secondary
Percentage of at Least 50 % Responders During the Treatment Period (Maximum 6 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.
Time frame: Treatment Period (Maximum 6 years)
Population: Of the 308 subjects who were enrolled/treated in the study, 307 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 SP756 study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lacosamide | Percentage of at Least 50 % Responders During the Treatment Period (Maximum 6 Years) | 48.2 percentage of subjects |