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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT00319501

Public ClinicalTrials.gov record NCT00319501. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 21, 2026, 11:06 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Study identification

NCT ID
NCT00319501
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Pfizer
Industry
Enrollment
234 participants

Conditions and interventions

Interventions

  • Placebo Drug
  • Vanquix Auto-Injector (Diazepam Injection) Drug

Drug

Eligibility (public fields only)

Age range
2 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 31, 2005
Primary completion
Jun 30, 2014
Completion
Jun 30, 2014
Last update posted
Sep 22, 2016

2006 – 2014

United States locations

U.S. sites
86
U.S. states
23
U.S. cities
47
Facility City State ZIP Site status
Neurology Clinic, PC Northport Alabama 35476
Clinical Trials, Inc Little Rock Arkansas 72205
Stein Life Child Neurology Medical Specialists Inc. Irvine California 92606
Collaborative NeuroScience Network, LLC Long Beach California 90806
Hoag Memorial Hospital Presbyterian Newport Beach California 92658
Brain and Spine Surgeons of Orange County Newport Beach California 92663
Drug Shipment Sacramento California 95816
Sacramento Comprehensive Epilepsy Program Sacramento California 95816
Sutter Cancer Center Specialty Clinic Sacramento California 95816
Sutter Institute for Medical Research Sacramento California 95816
Northern California Cardiology Sacramento California 95819
Bradenton Research Center, Inc. Bradenton Florida 34205
Morton Plant Hospital Epilepsy Clinic Clearwater Florida 33756
Morton Plant Hospital Pharmacy Clearwater Florida 33756
Child Neurology Center of NorthWest Florida Gulf Breeze Florida 32561
NorthWest Florida Clinical Research Group, LLC Gulf Breeze Florida 32561
Emery Neuroscience Center Lighthouse PT Florida 33064
Pediatric Neurology and Epilepsy Center Loxahatchee Groves Florida 33470
Miami Children's Hospital Miami Florida 33155
EKG only Orlando Florida 32806
Pediatric Neurology, PA Orlando Florida 32819
AMO Corp Tallahassee Florida 32308
Tallahassee Neurological Clinic Tallahassee Florida 32308
Pediatric Epilepsy & Neurology Specialists Tampa Florida 33609
Willsey Research Inc Tampa Florida 33613
Child Neurology Associates, PC Atlanta Georgia 30342
Savannah Neurology, PC Savannah Georgia 31405
Consultants in Epilepsy and Neurology, PLLC Boise Idaho 83702
Comer Children's Hospital Chicago Illinois 60637
University of Chicago Hospital Pharmacy Chicago Illinois 60637
University of Chicago Medical Center (UCMC) Center for Advanced Medicine (CAM) Chicago Illinois 60637
University of Chicago Medical Center (UCMC) Chicago Illinois 60637
University Neurologists PSC Pediatric Division Louisville Kentucky 40202
University of Louisville Ambulatory Care Building Clinic Louisville Kentucky 40202
University of Louisville Clinical Trials Unit Louisville Kentucky 40202
Lahey Clinic Medical Center Burlington Massachusetts 01805
Neurology Clinic of St Cloud Saint Cloud Minnesota 56303
The Comprehensive Epilepsy Care Center For Children and Adults Chesterfield Missouri 63017
MRI Location Kansas City Missouri 64111
St Luke's Hospital Neurological Consultants Kansas City Missouri 64111
St Luke's Hospital Kansas City Missouri 64111
Dartmouth-Hitchcock Medical Center Lebanon New Hampshire 03756
Clinical Research Center of New Jersey Gibbsboro New Jersey 08026
University of Medicine and Dentistry of New Jersey Robert Wood Johnson Medical Group New Brunswick New Jersey 08901
University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School New Brunswick New Jersey 08901
Elmwood Clinic Buffalo New York 14207
Millard Fillmore Gates Hospital/Comprehensive Epilepsy Center Buffalo New York 14209
Women and Children's Hospital of Buffalo Buffalo New York 14222
NYU Medical Center, Comprehensive Epilepsy Center New York New York 10016
Strong Memorial Hospital Rochester New York 14642
University of Rochester, Strong Epilepsy Center Rochester New York 14642
Cone Health Child Neurology Greensboro North Carolina 27401
Guilford Neurologic Associates Greensboro North Carolina 27405
Raleigh Neurology Associates, PA Raleigh North Carolina 27607
The Cleveland Clinic Foundation Cleveland Ohio 44195-5102
The Cleveland Clinic Health Systems Cleveland Ohio 44195-5102
Ohio State University Neurology Clinic Columbus Ohio 43210
Ohio State University University Hospital Columbus Ohio 43210
Ohio State University Columbus Ohio 43210
North Pacific Epilepsy Research/The Northrup Center Portland Oregon 97210
The Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104
St. Christopher's Hospital for Children Philadelphia Pennsylvania 19134-1095
St. Christopher's Hospital for Children Philadelphia Pennsylvania 19134
Wellspan Neurosciences York Pennsylvania 17402
Apple Hill Medical Center (EKG & Lab Draw) York Pennsylvania 17403
Medical University of South Carolina Hospitals and Clinics Charleston South Carolina 29425
Medical University of South Carolina/Department of Pharmacy Service Charleston South Carolina 29425
Medical University of South Carolina Charleston South Carolina 29425
The Neurology and Pain Clinic Orangeburg South Carolina 29118
Mid-South Physicians Group, PLLC Germantown Tennessee 38138
University of Tennessee Lebonheur Pediatric Specialists Inc. Memphis Tennessee 38103
Access Clinical Trial, Inc. Nashville Tennessee 37203
CMC - Physician's Park Nashville Tennessee 37203
Vanderbilt University Medical Center Nashville Tennessee 37232-2551
Vanderbilt Epilepsy Clinic Nashville Tennessee 37232
Vanderbilt University Hospital Pharmacy Nashville Tennessee 37232
Neurological Clinic of Texas, PA Dallas Texas 75230
Cook Children's Medical Center Office of Grants and Research Fort Worth Texas 76104
Cook Children's Medical Center Fort Worth Texas 76104
Cook Children's Physcian Network Fort Worth Texas 76104
Alamo City Clinical Research, LLC San Antonio Texas 78258
Virginia Commonwealth University Health System Richmond Virginia 23298-0042
Virginia Commonwealth University Division of Child Neurology Richmond Virginia 23298-0211
Virginia Commonwealth University Ambulatory Care Center/Department of Neurology Richmond Virginia 23298-0599
Harborview Medical Center Seattle Washington 98104
University of Washington Regional Epilepsy Center, Harborview Medical Center Seattle Washington 98104

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00319501, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 22, 2016 · Synced Jul 21, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00319501 live on ClinicalTrials.gov.

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