Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures



Status:Active, not recruiting
Conditions:Neurology, Epilepsy
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - 65
Updated:9/28/2018
Start Date:May 2011
End Date:December 2019

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A Phase 2 Multicenter, Double-blind, Randomized, Adjunctive, Placebo-controlled Trial With an Open-label Extension to Evaluate the Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures

This study is to evaluate the efficacy of YKP3089 in reducing seizure frequency when compared
to baseline in subjects with partial onset seizures not fully controlled despite their
treatment with 1 to 3 concomitant anti-epileptic drugs.

Also to evaluate the safety and tolerability of YKP3089.


Inclusion Criteria:

- Diagnosis of treatment resistant partial epilepsy;

- History of epilepsy for at least 2 years;

- 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.

- Currently treated on a stable dose of :

- 1 - 3 AED'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:

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.
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733 North Broadway
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3555 NW 58th St # 800
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2801 W. Bancroft
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