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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

Study:

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

Rationale:

n/a

Purpose:

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

Recruiting:
n/a

Condition Intervention Phase
Epilepsy
Epilepsy, Generalized
Epilepsy, Complex Partial
Epilepsies, Partial
Seizures		 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
ClinicalTrials.gov 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

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.