Study to Test the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adults With Drug-resistant Epilepsy



Status:Recruiting
Conditions:Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:3/24/2019
Start Date:February 12, 2018
End Date:February 2020
Contact:UCB Cares
Email:UCBCares@ucb.com
Phone:+1844599

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A Randomized, Double-Blind, Placebo-Controlled, Dose Finding Study to Evaluate the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-Onset Seizures in Adult Subjects With Drug-Resistant Epilepsy

The purpose of the study is to characterize the dose-response relationship with respect to
efficacy of Padsevonil administered concomitantly with up to 3 anti-epileptic drugs (AEDs)
for treatment of observable focal-onset seizures in subjects with drug-resistant epilepsy.


Inclusion Criteria:

- Diagnosis of focal epilepsy per 1989 International League Against Epilepsy (ILAE)
criteria at least 3 years before study entry

- Subject has failed to achieve seizure control with 4 tolerated and appropriately
chosen prior antiepileptic drugs (AED), including past and ongoing treatment, that
were individually optimized for adequate dose and duration. Prior discontinued AED
treatment would need to be assessed by the Investigator considering the patient
medical records and patient and/or caregiver interview. 'Prior AED' is defined as all
past and ongoing AED treatments with a start date before the Screening Visit (Visit 1)

- Average of >= 4 spontaneous and observable focal seizures (type IA1 (i.e. focal
aware), IB (i.e. focal impaired awareness), IC (i.e. focal to bilateral tonic-clonic))
per month

- Current treatment with an individually optimized and stable dose of at least 1 and up
to 3 AEDs for the 8 weeks prior to the Screening Visit with or without additional
Vagus Nerve Stimulation (VNS) or other neurostimulation treatments

Exclusion Criteria:

- Subject has a history of or signs of generalized or combined generalized and focal
epilepsy

- Cluster seizures which are uncountable in the previous 8 weeks before study entry and
during 4 weeks prospective baseline

- Current treatment with carbamazepine, phenytoin, primidone, phenobarbital

- Current treatment/ use of (non-AED) prescription, nonprescription, dietary (eg,
grapefruit or passion fruit), or herbal products that are potent inducers or
inhibitors of the CYP3A4 or 2C19 pathway for 2 weeks (or 5 half-lives, whichever is
longer) prior to the Baseline Visit

- Subjects taking sensitive substrates of CYP2C19 for 2 weeks (or 5 half-lives,
whichever is longer) prior to the Baseline Visit

- Subject has been taking vigabatrin less than 2 years at study entry

- Subject has been taking felbamate for less than 12 months

- Subject taking retigabine for less than 4 years

- Current treatment with benzodiazepines (i.e. GABA-A-ergic drugs like zolpidem,
zaleplon, or zopiclone, excluding GABA-A-ergic AEDs) <3 times per week for emergencies

- Subject has a current medical condition that occurred within the last 12 months which,
in the opinion of the investigator, could compromise his/her safety or ability to
participate in this study
We found this trial at
44
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Akron, Ohio 44308
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Atlanta, Georgia 30329
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Atlanta, Georgia 30303
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Austin, Texas 78701
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Austin, Texas 78758
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Baltimore, Maryland 21287
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Bethesda, Maryland 20817
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Box Hill,
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Chandler, Arizona 85226
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Charlotte, North Carolina 28207
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Charlotte, NC
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Chesterfield, Missouri 63017
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Cordova, Tennessee 38018
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Dallas, Texas 75231
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Dallas, Texas 75390
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Durham, North Carolina 27710
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Edison, New Jersey 08820
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Edison, NJ
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Hackensack, New Jersey 07601
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Honolulu, Hawaii 96817
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Johnson City, Tennessee 37604
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La Jolla, California 92037
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Little Rock, Arkansas 72205
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Loma Linda, California 92350
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Lubbock, Texas 79410
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Madison, Wisconsin 53705
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Milwaukee, Wisconsin 53211
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Mooresville, North Carolina 28117
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Nashville, Tennessee 37232
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New York, New York 10016
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New York, New York 10075
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Ocala, Florida 34471
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Orlando, Florida 32806
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Peoria, Illinois 61637
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Philadelphia, Pennsylvania 19107
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Philadelphia, Pennsylvania 19104
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Phoenix, Arizona 85004
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Phoenix, Arizona 85006
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Port Charlotte, Florida 33952
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Round Rock, Texas 78681
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Saint Paul, Minnesota 55102
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San Antonio, Texas 78229
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San Francisco, California 94115
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Stony Brook, New York 11794
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Tallahassee, Florida 32308
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Washington, District of Columbia 20037
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