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

PHASE3CompletedINTERVENTIONAL
Enrollment

234

Participants

Timeline

Start Date

January 31, 2006

Primary Completion Date

July 31, 2014

Study Completion Date

July 31, 2014

Conditions
SeizuresEpilepsies, PartialEpilepsy, Complex PartialEpilepsy, GeneralizedEpilepsy
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

Trial Locations (86)

10016

NYU Medical Center, Comprehensive Epilepsy Center, New York

14207

Elmwood Clinic, Buffalo

14209

Millard Fillmore Gates Hospital/Comprehensive Epilepsy Center, Buffalo

14222

Women and Children's Hospital of Buffalo, Buffalo

14642

Strong Memorial Hospital, Rochester

University of Rochester, Strong Epilepsy Center, Rochester

17402

Wellspan Neurosciences, York

17403

Apple Hill Medical Center (EKG & Lab Draw), York

19104

The Children's Hospital of Philadelphia, Philadelphia

19134

St. Christopher's Hospital for Children, Philadelphia

27401

Cone Health Child Neurology, Greensboro

27405

Guilford Neurologic Associates, Greensboro

27607

Raleigh Neurology Associates, PA, Raleigh

29118

The Neurology and Pain Clinic, Orangeburg

29425

Medical University of South Carolina Hospitals and Clinics, Charleston

Medical University of South Carolina/Department of Pharmacy Service, Charleston

Medical University of South Carolina, Charleston

30342

Child Neurology Associates, PC, Atlanta

31405

Savannah Neurology, PC, Savannah

32308

AMO Corp, Tallahassee

Tallahassee Neurological Clinic, Tallahassee

32561

Child Neurology Center of NorthWest Florida, Gulf Breeze

NorthWest Florida Clinical Research Group, LLC, Gulf Breeze

32806

EKG only, Orlando

32819

Pediatric Neurology, PA, Orlando

33064

Emery Neuroscience Center, Lighthouse PT

33155

Miami Children's Hospital, Miami

33470

Pediatric Neurology and Epilepsy Center, Loxahatchee Groves

33609

Pediatric Epilepsy & Neurology Specialists, Tampa

33613

Willsey Research Inc, Tampa

33756

Morton Plant Hospital Epilepsy Clinic, Clearwater

Morton Plant Hospital Pharmacy, Clearwater

34205

Bradenton Research Center, Inc., Bradenton

35476

Neurology Clinic, PC, Northport

37203

Access Clinical Trial, Inc., Nashville

CMC - Physician's Park, Nashville

37232

Vanderbilt Epilepsy Clinic, Nashville

Vanderbilt University Hospital Pharmacy, Nashville

38103

University of Tennessee Lebonheur Pediatric Specialists Inc., Memphis

38138

Mid-South Physicians Group, PLLC, Germantown

40202

University Neurologists PSC Pediatric Division, Louisville

University of Louisville Ambulatory Care Building Clinic, Louisville

University of Louisville Clinical Trials Unit, Louisville

43210

Ohio State University Neurology Clinic, Columbus

Ohio State University University Hospital, Columbus

Ohio State University, Columbus

56303

Neurology Clinic of St Cloud, Saint Cloud

60637

Comer Children's Hospital, Chicago

University of Chicago Hospital Pharmacy, Chicago

University of Chicago Medical Center (UCMC) Center for Advanced Medicine (CAM), Chicago

University of Chicago Medical Center (UCMC), Chicago

63017

The Comprehensive Epilepsy Care Center For Children and Adults, Chesterfield

64111

MRI Location, Kansas City

St Luke's Hospital Neurological Consultants, Kansas City

St Luke's Hospital, Kansas City

72205

Clinical Trials, Inc, Little Rock

75230

Neurological Clinic of Texas, PA, Dallas

76104

Cook Children's Medical Center Office of Grants and Research, Fort Worth

Cook Children's Medical Center, Fort Worth

Cook Children's Physcian Network, Fort Worth

78258

Alamo City Clinical Research, LLC, San Antonio

83702

Consultants in Epilepsy and Neurology, PLLC, Boise

90806

Collaborative NeuroScience Network, LLC, Long Beach

92606

Stein Life Child Neurology Medical Specialists Inc., Irvine

92658

Hoag Memorial Hospital Presbyterian, Newport Beach

92663

Brain and Spine Surgeons of Orange County, Newport Beach

95816

Drug Shipment, Sacramento

Sacramento Comprehensive Epilepsy Program, Sacramento

Sutter Cancer Center Specialty Clinic, Sacramento

Sutter Institute for Medical Research, Sacramento

95819

Northern California Cardiology, Sacramento

97210

North Pacific Epilepsy Research/The Northrup Center, Portland

98104

Harborview Medical Center, Seattle

University of Washington Regional Epilepsy Center, Harborview Medical Center, Seattle

01805

Lahey Clinic Medical Center, Burlington

03756

Dartmouth-Hitchcock Medical Center, Lebanon

08026

Clinical Research Center of New Jersey, Gibbsboro

08901

University of Medicine and Dentistry of New Jersey Robert Wood Johnson Medical Group, New Brunswick

University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, New Brunswick

44195-5102

The Cleveland Clinic Foundation, Cleveland

The Cleveland Clinic Health Systems, Cleveland

19134-1095

St. Christopher's Hospital for Children, Philadelphia

37232-2551

Vanderbilt University Medical Center, Nashville

23298-0042

Virginia Commonwealth University Health System, Richmond

23298-0211

Virginia Commonwealth University Division of Child Neurology, Richmond

23298-0599

Virginia Commonwealth University Ambulatory Care Center/Department of Neurology, Richmond

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY