Health Condition 1: null- Partial Onset Seizures
Conditions
Interventions
Intervention1: YKP3089: Capsule, dose to be titrated
Duration : 13 weeks
Control Intervention1: Placebo: Placebo capsule
Duration : 13 weeks
Sponsors
SK Life Science Inc
Quintiles Research India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1) Male or female subjects age 18-65 years inclusive 2) Subjects in otherwise good health (with the exception of epilepsy), as determined by the PI via the medical history, a physical examination and screening laboratory investigations. 3) A diagnosis of treatment resistant partial epilepsy 4) History of epilepsy for at least 2 years. 5) Have at least 3 simple partial with motor component, complex partial or secondarily generalized seizures per month with no consecutive 21 day seizure free period. 6) Currently treated on a stable dose of : • 1 â?? 3 AEDâ??s for at least 12 weeks prior to randomization. • VNS will not be counted as AED; however the parameters must remain stable for at least 4 weeks prior to baseline. • Benzodiazepines taken at least once per week for epilepsy, or for anxiety or sleep disorder, will be counted as 1 AED. Therefore only a maximum of two additional approved AEDs will be allowed.
Exclusion criteria
Exclusion criteria: 1. A history of alcoholism, drug abuse, or drug addiction within the past 2 years. 2. Subject has had status epilepticus within past 1 year. 3. Subject has had greater than 2 allergic reactions to an AED or one serious hypersensitivity reaction to an AED. 4. Subjects taking felbamate with less than 18 months continuous exposure. 5. Subjects receiving phenytoin, phenobarbitone or metabolites of these drugs. 6. No active suicidal plan/intent or active suicidal thoughts in the past 6 months. 7. History of suicide attempt in the last 2 years; not more than 1 lifetime suicide attempt. 8. Subject meets criteria for current major depressive episode (within 6 months). 9. Use of intermittent rescue benzodiazepines more than once/month (1-2 doses in a 24-hour period is considered one rescue) in the one month period prior to Visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in seizure frequency per 28 days in the Treatment Period compared to the Baseline in the Intention to Treat (ITT) PopulationTimepoint: per 28 days during 12 week treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| Responder rate: An analysis of subjects who experience a 50% or greater reduction in seizure frequency in the Treatment Period of the Double-blind PhaseTimepoint: 12 weeks | — |
Countries
India, Poland, Republic of Korea, United States of America
Contacts
Public ContactSuchela Srivatsa
Quintiles Research (India) Pvt. Ltd
Outcome results
None listed