NCT00319501

Efficacy and Safety of Diazepam in the Management of Refractory Epilepsy in Selected Patients Who Require Intermittent Medical Intervention for Acute Repetitive Seizures.

A Phase 3, Randomized, Double-blind, Parallel, Placebo-controlled, Multicenter Study, With Optional Open-label Continuation, Of The Efficacy And Safety Of Vanquix(tm) 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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 234 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of diazepam in the management of refractory epilepsy in selected patients who require intermittent medical intervention for the control of episodes of acute repetitive seizures. In addition, to assess the support provided by caregivers who are not themselves or not under the direct supervision of health care professionals at the time of administration.

Conditions

• Seizures
• Epilepsies, Partial
• Epilepsy, Complex Partial
• Epilepsy, Generalized
• Epilepsy

Interventions

Type	Name	Description
DRUG	Placebo	Intramuscular autoinjector; administered at onset of an episode
DRUG	Vanquix Auto-Injector (Diazepam Injection)	Intramuscular autoinjector: 5, 10, 15, or 20 mg (based on participant's age and weight); administered at the onset of an episode

Timeline

• Start date: 2006-01-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2006-04-27
• Last updated: 2016-09-23
• Results posted: 2016-08-16

Locations

86 sites across 1 country: United States