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

NCT00319501 ↗

Phase 3 Completed 234 enrolled Pfizer

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2006-01
Primary completion: 2014-07
Completion: 2014-07

Outcome

Met primary endpoint

paper hazard ratio of 0.55 (95% confidence interval [CI] 0.34–0.88; p = 0.012) for diazepam AI versus placebo AI PMID 24111974 ↗

Publications

Abou-Khalil B, Wheless J, Rogin J, Wolter KD, Pixton GC, Shukla RB, Sherman NA, Sommerville K, Goli V, Roland CL. A double-blind, randomized, placebo-controlled trial of a diazepam auto-injector administered by caregivers to patients with epilepsy who require intermittent intervention for acute repetitive seizures. Epilepsia. 2013 Nov;54(11):1968-76. doi: 10.1111/epi.12373. Epub 2013 Sep 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Diazepam	Small molecule	5 mg	Intramuscular
Subject	Diazepam	Small molecule	10 mg	Intramuscular
Subject	Diazepam	Small molecule	15 mg	Intramuscular
Subject	Diazepam	Small molecule	20 mg	Intramuscular