Partial Epilepsies, Partial Onset Seizures
Conditions
Keywords
Epilepsy, seizures, antiepileptic, Lacosamide, Vimpat, safety, adjunctive
Brief summary
The purpose of this study is to allow eligible subjects from the parent study, SP925 \[NCT00655551\] to continue lacosamide and to obtain additional long-term safety data
Detailed description
A multicenter, open-label extension study to assess the long-term safety and tolerability of lacosamide as adjunctive therapy in subjects with partial-onset seizures who were previously enrolled in the SP925 study \[NCT00655551\] (intravenous lacosamide loading dose followed by approximately 1 week of oral lacosamide maintenance).
Interventions
DRUGlacosamide
Subjects' dose of lacosamide may be increased or decreased as needed to maintain a subject's effective and tolerable dose during the study. Tablets are 50 mg or 100 mg each; Dose is 100 mg/day up to 800 mg/day administered twice daily throughout the study (up to 2 years).
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 60 Years
Healthy volunteers
No
Inclusion criteria
* Eligible subjects who participated in SP925 \[NCT00655551\] for treatment of partial-onset seizures
Exclusion criteria
* Receiving any study drug or experimental device other than lacosamide * Meets withdrawal criteria for parent study SP925 \[NCT00655551\] * Experiencing ongoing serious adverse event
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With at Least One Adverse Event During This Open-label Extension Study (Maximum Study Duration 2 Years) | 2 years | An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design). |
| Number of Subjects Who Withdrew From the Study Due to an Adverse Event (Maximum Study Duration 2 Years) | 2 years | An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design). |
Countries
United States
Participant flow
Recruitment details
The study started in April 2008 with enrollment occuring in the United States only. The study completed June 2010
Participants by arm
| Arm | Count |
|---|---|
| Lacosamide Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years) | 97 |
| Total | 97 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 10 |
| Overall Study | Lack of Efficacy | 8 |
| Overall Study | Other: Abnormal electrocardiogram (ECG) | 1 |
| Overall Study | Other: Could not tolerate BID dosing | 1 |
| Overall Study | Other: Pregnancy | 1 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Unsatisfactory compliance | 2 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Lacosamide |
|---|---|
| Age, Categorical <=18 years | 2 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 95 Participants |
| Age, Continuous | 38.8 years STANDARD_DEVIATION 11.71 |
| Region of Enrollment United States | 97 participants |
| Sex: Female, Male Female | 47 Participants |
| Sex: Female, Male Male | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 88 / 97 |
| serious Total, serious adverse events | 10 / 97 |
Outcome results
Primary
Number of Subjects Who Withdrew From the Study Due to an Adverse Event (Maximum Study Duration 2 Years)
An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).
Time frame: 2 years
Population: All 97 subjects enrolled are in the Safety Set (SS) and are included in this analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lacosamide | Number of Subjects Who Withdrew From the Study Due to an Adverse Event (Maximum Study Duration 2 Years) | 10 subjects |
Primary
Number of Subjects With at Least One Adverse Event During This Open-label Extension Study (Maximum Study Duration 2 Years)
An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).
Time frame: 2 years
Population: All 97 subjects enrolled are in the Safety Set (SS) and are included in this analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lacosamide | Number of Subjects With at Least One Adverse Event During This Open-label Extension Study (Maximum Study Duration 2 Years) | 93 subjects |