Epilepsy
Conditions
Keywords
Primary Generalized Tonic-Clonic (PGTC) Seizures, Absence Seizures, Myoclonic Seizures, Idiopathic Generalized Epilepsy (IGE)
Brief summary
The purpose is to obtain data on the safety and seizure frequency associated with long-term oral Lacosamide for uncontrolled primary generalized tonic-clonic (PGTC) seizures in subjects with idiopathic generalized Epilepsy. Additionally, to allow subjects who have completed SP0961 (NCT01118949) to continue to receive Lacosamide.
Interventions
DRUGLacosamide
Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949). At the beginning of SP0962, the dose may be maintained, or increased or decreased by 100 mg /day, as deemed clinically appropriate to optimize tolerability and seizure reduction. Dose increases should be no faster than 100 mg/ day per week up to a maximum of 800 mg/ day. Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses for up to a 56-week Treatment Phase. The Treatment Phase was followed by a 5-week End-of-Study Phase, during which subjects had to be tapered off Lacosamide at a recommended decrease rate of 200 mg/ day per week.
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 65 Years
Healthy volunteers
No
Inclusion criteria
* Subject completed the SP0961 (NCT01118949) study * Subject is expected to benefit from participation in an open-label extension study with Lacosamide, in the opinion of the investigator
Exclusion criteria
* Subject meets the withdrawal criteria for SP0961 (NCT01118949) or is experiencing an ongoing Serious Adverse Event (SAE)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks) | From Visit 1 to the end of study (Approximately 61 weeks) |
| Number of Participants Withdrawn From the Study Due to Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks) | From Visit 1 to the end of study (Approximately 61 weeks) |
Countries
United States
Participant flow
Recruitment details
This study began enrollment in August 2010. The study completed in October 2012. The participant flow consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
Participants by arm
| Arm | Count |
|---|---|
| Lacosamide Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949).
Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses. | 39 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Non-compliance with Medicinal Product | 1 |
| Overall Study | Pregnancy | 1 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Lacosamide |
|---|---|
| Age, Categorical <=18 years | 3 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants |
| Age, Continuous | 30.3 years STANDARD_DEVIATION 10.7 |
| Height | 167.88 Centimeters STANDARD_DEVIATION 8.25 |
| Region of Enrollment United States | 39 participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 11 Participants |
| Weight | 77.66 Kilograms STANDARD_DEVIATION 17.58 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 35 / 39 |
| serious Total, serious adverse events | 3 / 39 |
Outcome results
Primary
Number of Participants Withdrawn From the Study Due to Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks)
Time frame: From Visit 1 to the end of study (Approximately 61 weeks)
Population: Of the 39 subjects in the Safety Set (SS), 39 were included in this analysis.~The SS consists of all subjects that were dosed at least once with Lacosamide (LCM).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lacosamide | Number of Participants Withdrawn From the Study Due to Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks) | 2 participants |
Primary
Number of Participants With Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks)
Time frame: From Visit 1 to the end of study (Approximately 61 weeks)
Population: Of the 39 subjects in the Safety Set (SS), 39 were included in this analysis.~The SS consists of all subjects that were dosed at least once with Lacosamide (LCM).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lacosamide | Number of Participants With Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks) | 37 participants |