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

Completed · Phase 2 · Has a placebo group

Conditions studied: Partial Epilepsy

In brief

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.

Key facts

Study ID

NCT01397968

Run by

SK Life Science, Inc.

People needed

222

Starts

2011-07-06

Expected to finish

2021-01-28

Last updated by the study team

2022-04-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• A history of alcoholism, drug abuse, or drug addiction within the past 2 years.
• Subject has had status epilepticus within past 1 year.
• Subject has had greater than 2 allergic reactions to an AED or one serious hypersensitivity reaction to an AED.
• Subjects taking felbamate with less than 18 months continuous exposure.
• Subjects receiving phenytoin, phenobarbitone or metabolites of these drugs.
• No active suicidal plan/intent or active suicidal thoughts in the past 6 months.
• History of suicide attempt in the last 2 years; not more than 1 lifetime suicide attempt.
• Subject meets criteria for current major depressive episode (within 6 months).
• 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.

Where it is running

• St. Joseph Hospital & Medical Center/Barrow Neurology Clinic — Phoenix, Arizona, United States
• Clinical Trials, Inc. — Little Rock, Arkansas, United States
• Kaiser Permanente — Anaheim, California, United States
• VA Greater Los Angeles Healthcare System — Los Angeles, California, United States
• Bradenton Research Center, Inc. — Bradenton, Florida, United States
• Bluegrass Epilepsy Research, LLC — Lexington, Kentucky, United States
• John's Hopkins University School of Medicine — Baltimore, Maryland, United States
• Mid-Atlantic Epilepsy and Sleep Center — Bethesda, Maryland, United States
• Suite 209 South — Chesterfield, Missouri, United States
• Ohio State University Medical Center — Columbus, Ohio, United States
• The University of Toledo — Toledo, Ohio, United States
• Lynn Health Science Institute — Oklahoma City, Oklahoma, United States
• University of Pennsylvania Health System — Philadelphia, Pennsylvania, United States
• Thomas Jefferson University Comprehensive Epilepsy Center — Philadelphia, Pennsylvania, United States
• Neurological Clinic of Texas, P.A. — Dallas, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States
• St. Theresa's General Hospital — Hyderabad, Andhra Pradesh, India
• M.S. Ramaiah Medical College and Hospital — Bangalore, Karnataka, India
• Bangalore Clinisearch — Bangalore, Karnataka, India
• Mallikatta Neuro Centre — Mangalore, Karnataka, India
• Deenanath Mangeshkar Hospital & Research Centre — Pune, Maharashtra, India
• Max Super Specialty Hospital — Sāket, New Delhi, India
• Nightingale Hospital — Kolkata, West Bengal, India
• NZOZ Vito-Med Sp. Zo.o — Gliwice, Poland
• NZOZ Diagnomed — Katowice, Poland

Full record on ClinicalTrials.gov

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