A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Trial of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures

Completed · Phase 2 · Has a placebo group

Conditions studied: Partial Epilepsy

In brief

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 phase and 12 week maintenance phase), followed by a 3-week blinded study drug taper period (for subjects leaving the study) or a 2-week blinded conversion period (for subjects who will participate in the open-label extension). The primary objective of this study is to determine the effective dose range of YKP3089 as adjunctive therapy for the treatment of partial seizures. The trial will also evaluate the safety and tolerability of YKP3089 in the partial epilepsy population.

Key facts

Study ID

NCT01866111

Run by

SK Life Science, Inc.

People needed

437

Starts

2013-07-31

Expected to finish

2021-10-31

Last updated by the study team

2025-06-24

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Clinical Trials, Inc. — Little Rock, Arkansas, United States
• Kaiser Permanente, Department of Neurology — Anaheim, California, United States
• Neuro-Pain Medical Center — Fresno, California, United States
• West Los Angeles VA Medical Center, Clinical Research Center — Los Angeles, California, United States
• Neuroresearch, Inc. - Torrance — Torrance, California, United States
• Neuroresearch II, Inc. — Ventura, California, United States
• Bradenton Research Center, Inc. — Bradenton, Florida, United States
• Lovelace Scientific Resources, Inc. — Sarasota, Florida, United States
• Consultants in Epilepsy & Neurology, PLLC — Boise, Idaho, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Mid-Atlantic Epilepsy and Sleep Center — Bethesda, Maryland, United States
• Neurology Clinic PC — Waldorf, Maryland, United States
• The Comprehensive Epilepsy Care Center for Children and Adults — St Louis, Missouri, United States
• Northeast Regional Epilepsy Group — Hackensack, New Jersey, United States
• NYU Comprehensive Epilepsy Center — New York, New York, United States
• The Neurological Institute, PA — Charlotte, North Carolina, United States
• Thomas Jefferson Comprehensive Epilepsy Center — Philadelphia, Pennsylvania, United States
• Vanderbilt Epilepsy Clinic — Nashville, Tennessee, United States
• Austin Epilepsy Care Center — Austin, Texas, United States
• University of Virginia Comprehensive Epilepsy Program — Charlottesville, Virginia, United States
• Institute of Neurological Sciences, Prince of Wales Hospital — Randwick, New South Wales, Australia
• Monash Medical Centre — Clayton, Victoria, Australia
• St. Vincent's Hospital (Melbourne) — Fitzroy, Victoria, Australia
• Epilepsy Research Centre, Melbourne Brain Centre — Heidelberg, Victoria, Australia
• St. Joseph's Hospital and Medical Center - Barrow Neurology Clinics — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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