drugset / Trial / NCT00319501

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

Drugs

EvaluationDrugModalityDoseRoute
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