Status:
COMPLETED
A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Trial of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures
Lead Sponsor:
SK Life Science, Inc.
Conditions:
Partial Epilepsy
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This is a multicenter, double-blind, randomized, placebo-controlled dose response study, with an 8-week prospective baseline and an 18 week double-blind treatment period (including a 6-week titration ...
Eligibility Criteria
Inclusion
- Weight at least 40 kg
- A diagnosis of partial epilepsy according to the International League Against Epilepsy's Classification of Epileptic Seizures. Diagnosis should have been established by clinical history and an electroencephalogram (EEG) that is consistent with localization related epilepsy; normal interictal EEGs will be allowed provided that the subject meets the other diagnosis criterion (ie, clinical history)
- Have uncontrolled partial seizures despite having been treated with at least 1 AED within approximately the last 2 years
- During the 8-week baseline period, subjects must have at least 8 partial seizures including only simple partial seizures with motor component, complex partial seizures, or secondarily generalized seizures without a seizure-free interval of greater than 25 days any time during the 8 weeks baseline. Subjects must have at least 3 of these partial seizures during each of the two consecutive 4-week segments of the baseline period
- Currently on stable antiepileptic treatment regimen.
Exclusion
- A history of nonepileptic or psychogenic seizures
- Presence of only nonmotor simple partial seizures or primary generalized epilepsies
- Presence or previous history of Lennox-Gastaut syndrome
- An active CNS infection, demyelinating disease, degenerative neurologic disease, or any CNS disease deemed to be progressive during the course of the study that may confound the interpretation of the study results
- Any clinically significant psychiatric illness, psychological, or behavioral problems that, in the opinion of the Investigator, would interfere with the subject's ability to participate in the study
- History of alcoholism, drug abuse, or drug addiction within the past 2 years
- History of status epilepticus within 3 months of Visit 1
- A "yes" answer to Question 1 or 2 of the C-SSRS (Baseline/Screening version) Ideation Section in the past 6 months or a "yes" answer to any of the Suicidal Behavior Questions in the past 2 years
- More than 1 lifetime suicide attempt
- Participation in any other trials involving an investigational product or device within 30 days of screening (or longer, as required by local regulations)
- A history of any previous exposure to YKP3089
Key Trial Info
Start Date :
July 31 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2021
Estimated Enrollment :
437 Patients enrolled
Trial Details
Trial ID
NCT01866111
Start Date
July 31 2013
End Date
October 31 2021
Last Update
June 24 2025
Active Locations (67)
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1
St. Joseph's Hospital and Medical Center - Barrow Neurology Clinics
Phoenix, Arizona, United States, 85013
2
Clinical Trials, Inc.
Little Rock, Arkansas, United States, 72205
3
Kaiser Permanente, Department of Neurology
Anaheim, California, United States, 92806
4
Neuro-Pain Medical Center
Fresno, California, United States, 93710