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

NCT00319501 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 234

Last updated 2016-09-23

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00319501 on ClinicalTrials.gov