Epilepsy, Complex Partial Clinical Trial
Official title:
The Open Label Extension Portion of the Study Entitled A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Carisbamate as Adjunctive Therapy in Subjects With Partial Onset Seizures.
Verified date | June 2013 |
Source | SK Life Science |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to obtain long-term safety and tolerability information on carisbamate as add-on therapy for the treatment of partial onset seizures in patients with epilepsy. Seizure counts will be obtained to measure the rate of seizures for each patient during the study.
Status | Completed |
Enrollment | 403 |
Est. completion date | August 2010 |
Est. primary completion date | August 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years and older |
Eligibility |
Inclusion Criteria: - Must have completed the 14-week double-blind treatment phase of study CARISEPY3013 - must be willing/able to follow the restrictions and prohibitions of the protocol - must be able to complete the patient diaries correctly (patients or legally acceptable representatives) - must sign an informed consent form indicating agreement to participate in the study (patients or legally acceptable representatives) - adolescents capable of understanding the nature of the study must provide assent to participate in the study Exclusion Criteria: - Patients who have not completed the 14-week double-blind treatment phase of study CARISEPY3013. |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
SK Life Science |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety will be evaluated by the monitoring of the frequency, severity, and timing of adverse events, clinical laboratory test results, 12-lead electrocardiogram (ECG) recordings, vital signs measurements, physical and neurologic examinations | after a stable dose of Carisbamate is achieved, study visits to assess safety will be every three months for the duration of the subject's participation; subjects will also maintain a seizure count diary | No | |
Secondary | To evaluate the impact of carisbamate on subject functioning and well being using the QOLIE-31 Patient Inventory (as exploratory). Administered at month 3 and end of study. | after a stable dose of Carisbamate is achieved, study visits to assess safety will be every three months for the duration of the subject's participation; subjects will also maintain a seizure count diary | No |
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