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



Status:Active, not recruiting
Conditions:Neurology, Epilepsy
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - 70
Updated:4/22/2018
Start Date:July 2013
End Date:December 2019

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A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Dose-Response Trial of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures, With Optional Open-Label Extension

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.


Inclusion Criteria:

- 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 Criteria:

- 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
We found this trial at
29
sites
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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3924 9th Avenue West
Bradenton, Florida 34205
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736 E Bullard Ave
Fresno, California 93710
559-437-9700
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Anaheim, California 92806
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Austin, Texas 78758
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Bethesda, Maryland 20817
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Charlotte, North Carolina
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Chatswood, New South Wales 2067
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Indianapolis, Indiana 46256
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Lexington, Kentucky 40536
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Little Rock, Arkansas 72205
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Nashville, Tennessee 37232
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New York, New York 10016
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Philadelphia, Pennsylvania 19107
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222 South Woods Mill Road
Saint Louis, Missouri 63131
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Sarasota, Florida 34233
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Torrance, California 90505
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Ventura, California 93003
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Waldorf, Maryland 20603
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