Efficacy and Safety of Diazepam in the Management of Refractory Epilepsy in Selected Patients Who Require Intermittent Medical Intervention for Acute Repetitive Seizures.
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
2 other identifiers
interventional
234
1 country
86
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2006
Longer than P75 for phase_3
86 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 27, 2006
CompletedFirst Posted
Study publicly available on registry
April 27, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedResults Posted
Study results publicly available
August 16, 2016
CompletedSeptember 23, 2016
July 1, 2016
8.5 years
April 27, 2006
July 6, 2016
August 17, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Time to Next Seizure or Rescue Medication During the Double-blind Period (Kaplan-Meier 50th Percentile)
An event was defined as an episode of or required rescue medication for an episode of acute repetitive seizures (ARS) within 15 minutes to 12 hours following study drug administration. Patients without an ARS event were censored at 12 hours. Diaries were provided; if no diary was returned, or the diary did not provide answers to questions about seizures and rescue during the 12-hour follow-up period, the patient was considered censored as of 15 minutes past the treatment time, unless another contact was documented. If seizure control following study drug administration was inadequate, diazepam rectal gel was provided as a rescue medication, given only in the first 4 hours after study drug administration and only if the caregiver was directed to do so by the Investigator or designee at the time of the ARS episode. Patients and their caregivers were trained to recognize the onset of an episode of ARS and when and how to administer study drug.
From 15 minutes to 12 hours after study drug administration for an episode of ARS during the Double-blind Period
Percentage of Participants With an Event (Next Seizure or Rescue Medication) During the Open-label Period
An event was defined as an episode of or required rescue medication for an episode of acute repetitive seizures (ARS) within 15 minutes to 12 hours following study drug administration. Patients without an ARS event were censored at 12 hours. Diaries were provided; if no diary was returned, or the diary did not provide answers to questions about seizures and rescue during the 12-hour follow-up period, the patient was considered censored as of 15 minutes past the treatment time, unless another contact was documented. If seizure control following study drug administration was inadequate, diazepam rectal gel was provided as a rescue medication, given only in the first 4 hours after study drug administration and only if the caregiver was directed to do so by the Investigator or designee at the time of the ARS episode. Patients and their caregivers were trained to recognize the onset of an episode of ARS and when and how to administer study drug.
From 15 minutes to 12 hours after study drug administration for an episode of ARS during the Double-blind Period
Secondary Outcomes (10)
Number of Participants Requiring Rescue Medication During the Double-blind Period
From 15 minutes to 12 hours following study drug administration for an episode of ARS during the Double-blind Period
Number of Participants Requiring Emergency Department Visits During the Double-blind Period
From 15 minutes to 12 hours following study drug administration for onset of an episode of ARS during the Double-blind Period
Number of Participants Requiring Rescue Medical Care Other Than Rescue Medication or Emergency Department Visits During the Double-blind Period
From 15 minutes to 12 hours following study drug administration for an episode of ARS during the Double-blind Period
Mean Score on Caregiver Global Treatment Assessment During the Double-blind Period
Assessments completed at the end of each treated episode of ARS in the Double-blind Period
Mean Score on Physician Global Treatment Assessment During the Double-blind Period
At Visit 2 and subsequent visits in the Double-blind Period
- +5 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORDuring the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS).
Diazepam
EXPERIMENTALDuring the Double-blind Period, participants received a single, age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, as a deep intramuscular injection in the mid to outer thigh. Additional doses were permissible during the Open-label Period. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
Interventions
Intramuscular autoinjector: 5, 10, 15, or 20 mg (based on participant's age and weight); administered at the onset of an episode
Eligibility Criteria
You may qualify if:
- For Patient:
- Older than 2 years of age and between 6 and 136 kg body weight
- Recipient of clinical diagnosis of epilepsy, taking a stable antiepileptic drug regimen for at least 2 weeks, and requiring intermittent medical intervention to control episodes of acute repetitive seizures (ARS)
- Experienced at least 2 episodes of ARS in previous year, one of which occurred in previous 6 months
- Has episodes of ARS that include complex partial or generalized seizures
- Has a responsible caregiver available to participate
- Is not pregnant or lactating and is practicing an acceptable method of birth control.
- For Caregiver:
- Age of 18 years or older and has demonstrated responsibility as a caregiver through training to:
- Recognize an episode of repetitive seizures for which the injection was intended,
- Administer study drug
- Count and record seizures and respiratory rate in the patient diary,
- Monitor the patient and record observations in the patient diary for 12 hours following study drug treatment
- Recognize the need for immediate medical attention.
You may not qualify if:
- For Patient:
- Petit mal status or petit mal variant status
- History of ARS consistently progressing to status epilepticus
- History of failure to respond to benzodiazepine treatment
- Hypersensitivity to diazepam
- Acute narrow angle glaucoma
- Alcohol and/or other substance abuse
- Has taken another investigational drug in previous 30 days
- Acute or progressive neurologic or severe psychiatric disease or severe mental abnormality.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (86)
Neurology Clinic, PC
Northport, Alabama, 35476, United States
Clinical Trials, Inc
Little Rock, Arkansas, 72205, United States
Stein Life Child Neurology Medical Specialists Inc.
Irvine, California, 92606, United States
Collaborative NeuroScience Network, LLC
Long Beach, California, 90806, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92658, United States
Brain and Spine Surgeons of Orange County
Newport Beach, California, 92663, United States
Drug Shipment
Sacramento, California, 95816, United States
Sacramento Comprehensive Epilepsy Program
Sacramento, California, 95816, United States
Sutter Cancer Center Specialty Clinic
Sacramento, California, 95816, United States
Sutter Institute for Medical Research
Sacramento, California, 95816, United States
Northern California Cardiology
Sacramento, California, 95819, United States
Bradenton Research Center, Inc.
Bradenton, Florida, 34205, United States
Morton Plant Hospital Epilepsy Clinic
Clearwater, Florida, 33756, United States
Morton Plant Hospital Pharmacy
Clearwater, Florida, 33756, United States
Child Neurology Center of NorthWest Florida
Gulf Breeze, Florida, 32561, United States
NorthWest Florida Clinical Research Group, LLC
Gulf Breeze, Florida, 32561, United States
Emery Neuroscience Center
Lighthouse PT, Florida, 33064, United States
Pediatric Neurology and Epilepsy Center
Loxahatchee Groves, Florida, 33470, United States
Miami Children's Hospital
Miami, Florida, 33155, United States
EKG only
Orlando, Florida, 32806, United States
Pediatric Neurology, PA
Orlando, Florida, 32819, United States
AMO Corp
Tallahassee, Florida, 32308, United States
Tallahassee Neurological Clinic
Tallahassee, Florida, 32308, United States
Pediatric Epilepsy & Neurology Specialists
Tampa, Florida, 33609, United States
Willsey Research Inc
Tampa, Florida, 33613, United States
Child Neurology Associates, PC
Atlanta, Georgia, 30342, United States
Savannah Neurology, PC
Savannah, Georgia, 31405, United States
Consultants in Epilepsy and Neurology, PLLC
Boise, Idaho, 83702, United States
Comer Children's Hospital
Chicago, Illinois, 60637, United States
University of Chicago Hospital Pharmacy
Chicago, Illinois, 60637, United States
University of Chicago Medical Center (UCMC) Center for Advanced Medicine (CAM)
Chicago, Illinois, 60637, United States
University of Chicago Medical Center (UCMC)
Chicago, Illinois, 60637, United States
University Neurologists PSC Pediatric Division
Louisville, Kentucky, 40202, United States
University of Louisville Ambulatory Care Building Clinic
Louisville, Kentucky, 40202, United States
University of Louisville Clinical Trials Unit
Louisville, Kentucky, 40202, United States
Lahey Clinic Medical Center
Burlington, Massachusetts, 01805, United States
Neurology Clinic of St Cloud
Saint Cloud, Minnesota, 56303, United States
The Comprehensive Epilepsy Care Center For Children and Adults
Chesterfield, Missouri, 63017, United States
MRI Location
Kansas City, Missouri, 64111, United States
St Luke's Hospital Neurological Consultants
Kansas City, Missouri, 64111, United States
St Luke's Hospital
Kansas City, Missouri, 64111, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Clinical Research Center of New Jersey
Gibbsboro, New Jersey, 08026, United States
University of Medicine and Dentistry of New Jersey Robert Wood Johnson Medical Group
New Brunswick, New Jersey, 08901, United States
University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901, United States
Elmwood Clinic
Buffalo, New York, 14207, United States
Millard Fillmore Gates Hospital/Comprehensive Epilepsy Center
Buffalo, New York, 14209, United States
Women and Children's Hospital of Buffalo
Buffalo, New York, 14222, United States
NYU Medical Center, Comprehensive Epilepsy Center
New York, New York, 10016, United States
Strong Memorial Hospital
Rochester, New York, 14642, United States
University of Rochester, Strong Epilepsy Center
Rochester, New York, 14642, United States
Cone Health Child Neurology
Greensboro, North Carolina, 27401, United States
Guilford Neurologic Associates
Greensboro, North Carolina, 27405, United States
Raleigh Neurology Associates, PA
Raleigh, North Carolina, 27607, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195-5102, United States
The Cleveland Clinic Health Systems
Cleveland, Ohio, 44195-5102, United States
Ohio State University Neurology Clinic
Columbus, Ohio, 43210, United States
Ohio State University University Hospital
Columbus, Ohio, 43210, United States
Ohio State University
Columbus, Ohio, 43210, United States
North Pacific Epilepsy Research/The Northrup Center
Portland, Oregon, 97210, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134-1095, United States
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134, United States
Wellspan Neurosciences
York, Pennsylvania, 17402, United States
Apple Hill Medical Center (EKG & Lab Draw)
York, Pennsylvania, 17403, United States
Medical University of South Carolina Hospitals and Clinics
Charleston, South Carolina, 29425, United States
Medical University of South Carolina/Department of Pharmacy Service
Charleston, South Carolina, 29425, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
The Neurology and Pain Clinic
Orangeburg, South Carolina, 29118, United States
Mid-South Physicians Group, PLLC
Germantown, Tennessee, 38138, United States
University of Tennessee Lebonheur Pediatric Specialists Inc.
Memphis, Tennessee, 38103, United States
Access Clinical Trial, Inc.
Nashville, Tennessee, 37203, United States
CMC - Physician's Park
Nashville, Tennessee, 37203, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-2551, United States
Vanderbilt Epilepsy Clinic
Nashville, Tennessee, 37232, United States
Vanderbilt University Hospital Pharmacy
Nashville, Tennessee, 37232, United States
Neurological Clinic of Texas, PA
Dallas, Texas, 75230, United States
Cook Children's Medical Center Office of Grants and Research
Fort Worth, Texas, 76104, United States
Cook Children's Medical Center
Fort Worth, Texas, 76104, United States
Cook Children's Physcian Network
Fort Worth, Texas, 76104, United States
Alamo City Clinical Research, LLC
San Antonio, Texas, 78258, United States
Virginia Commonwealth University Health System
Richmond, Virginia, 23298-0042, United States
Virginia Commonwealth University Division of Child Neurology
Richmond, Virginia, 23298-0211, United States
Virginia Commonwealth University Ambulatory Care Center/Department of Neurology
Richmond, Virginia, 23298-0599, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
University of Washington Regional Epilepsy Center, Harborview Medical Center
Seattle, Washington, 98104, United States
Related Publications (1)
Abou-Khalil B, Wheless J, Rogin J, Wolter KD, Pixton GC, Shukla RB, Sherman NA, Sommerville K, Goli V, Roland CL. A double-blind, randomized, placebo-controlled trial of a diazepam auto-injector administered by caregivers to patients with epilepsy who require intermittent intervention for acute repetitive seizures. Epilepsia. 2013 Nov;54(11):1968-76. doi: 10.1111/epi.12373. Epub 2013 Sep 20.
PMID: 24111974DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2006
First Posted
April 27, 2006
Study Start
January 1, 2006
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
September 23, 2016
Results First Posted
August 16, 2016
Record last verified: 2016-07