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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 Oct 21, 2026, 7:35 PM 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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

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

Conditions and interventions

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
Jan 2006 (Type not available)
Primary completion
Jul 2014 (Actual)
Completion
Jul 2014 (Actual)
Last update posted
Sep 23, 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 23, 2016 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00319501 live on ClinicalTrials.gov.

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