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A Study on the Effectiveness and Safety of Diazepam Injection (Vanquix™) for Patients With Epilepsy That Receive Antiepileptic Drugs, But Still Experience Acute Repetitive Seizures (Bouts or Clusters of Seizures) That Require Treatment


A Phase III, Randomized Double-Blind, Parallel, Placebo-Controlled, Multicenter Study, With Optional Open-Label Continuation, of the Safety and Efficacy of Vanquix™ Auto-Injector (Diazepam Injection) for the Management of Selected, Refractory Patients With Epilepsy Who Require Intermittent Medical Intervention to Control Episodes of Acute Repetitive Seizures




The purpose of this study is to determine if there is a difference in the number of seizures and adverse events after a diazepam or placebo injection is given to control acute repetitive seizures.

Study Status: Recruiting


Condition Intervention Phase
Epilepsy, Generalized
Epilepsy, Complex Partial
Epilepsies, Partial
Drug: Diazepam
Drug: Placebo
Phase 3

Verified by King Pharmaceuticals Research and Development August, 2011

Sponsored by: King Pharmaceuticals Research and Development
Information provided by: King Pharmaceuticals Research and Development identifier: NCT00319501

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Cleveland Clinic
Cleveland, Ohio 44195
United States

Kevin Wolter, M.D.., Study Director

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