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ARISE: pAdsevonil in drug-ResIStant Epilepsy: 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, PHASE 2

Study Details

The primary objectives of this study are to characterize the dose-response relationship with respect to efficacy of PSL administered concomitantly with up to 3 anti-epileptic drugs (AEDs) for treatment of observable focal-onset seizures in subjects with drug-resistant epilepsy and to evaluate the efficacy of the 4 selected dose regimens of PSL compared with placebo. The secondary objective is to assess the safety and tolerability of all doses of PSL in relation to placebo.

Primary Sponsor:

Padsevonil (PSL)

Prinicipal Investigator:

Mohamad Koubeissi, MD

Contact Phone:

(202) 741-2717
ARISE: pAdsevonil in drug-ResIStant Epilepsy: 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, PHASE 2 mbahri@mfa.gwu.edu

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