A clinical trial to study the adjunctive effects of YKP3089 in patients with treatment resistant partial onset seizures.
- Conditions
- Health Condition 1: null- Partial Onset Seizures
- Registration Number
- CTRI/2012/03/002500
- Lead Sponsor
- SK Life Science Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 200
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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