Efficacy and Safety of Diazepam in the Management of Refractory Epilepsy in Selected Patients Who Require Intermittent Medical Intervention for Acute Repetitive Seizures.
Seizures, Epilepsies, Partial, Epilepsy, Complex Partial
About this trial
This is an interventional treatment trial for Seizures focused on measuring Acute Repetitive Seizures, ARS, Diazepam, Cluster Seizures
Eligibility Criteria
Key Inclusion Criteria 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. Key Exclusion Criteria 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.
Sites / Locations
- Neurology Clinic, PC
- Clinical Trials, Inc
- Stein Life Child Neurology Medical Specialists Inc.
- Collaborative NeuroScience Network, LLC
- Hoag Memorial Hospital Presbyterian
- Brain and Spine Surgeons of Orange County
- Drug Shipment
- Sacramento Comprehensive Epilepsy Program
- Sutter Cancer Center Specialty Clinic
- Sutter Institute for Medical Research
- Northern California Cardiology
- Bradenton Research Center, Inc.
- Morton Plant Hospital Epilepsy Clinic
- Morton Plant Hospital Pharmacy
- Child Neurology Center of NorthWest Florida
- NorthWest Florida Clinical Research Group, LLC
- Emery Neuroscience Center
- Pediatric Neurology and Epilepsy Center
- Miami Children's Hospital
- EKG only
- Pediatric Neurology, PA
- AMO Corp
- Tallahassee Neurological Clinic
- Pediatric Epilepsy & Neurology Specialists
- Willsey Research Inc
- Child Neurology Associates, PC
- Savannah Neurology, PC
- Consultants in Epilepsy and Neurology, PLLC
- Comer Children's Hospital
- University of Chicago Hospital Pharmacy
- University of Chicago Medical Center (UCMC) Center for Advanced Medicine (CAM)
- University of Chicago Medical Center (UCMC)
- University Neurologists PSC Pediatric Division
- University of Louisville Ambulatory Care Building Clinic
- University of Louisville Clinical Trials Unit
- Lahey Clinic Medical Center
- Neurology Clinic of St Cloud
- The Comprehensive Epilepsy Care Center For Children and Adults
- MRI Location
- St Luke's Hospital Neurological Consultants
- St Luke's Hospital
- Dartmouth-Hitchcock Medical Center
- Clinical Research Center of New Jersey
- University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School
- University of Medicine and Dentistry of New Jersey Robert Wood Johnson Medical Group
- Elmwood Clinic
- Millard Fillmore Gates Hospital/Comprehensive Epilepsy Center
- Women and Children's Hospital of Buffalo
- NYU Medical Center, Comprehensive Epilepsy Center
- Strong Memorial Hospital
- University of Rochester, Strong Epilepsy Center
- Cone Health Child Neurology
- Guilford Neurologic Associates
- Raleigh Neurology Associates, PA
- The Cleveland Clinic Foundation
- The Cleveland Clinic Health Systems
- Ohio State University Neurology Clinic
- Ohio State University University Hospital
- Ohio State University
- North Pacific Epilepsy Research/The Northrup Center
- The Children's Hospital of Philadelphia
- St. Christopher's Hospital for Children
- St. Christopher's Hospital for Children
- Wellspan Neurosciences
- Apple Hill Medical Center (EKG & Lab Draw)
- Medical University of South Carolina Hospitals and Clinics
- Medical University of South Carolina/Department of Pharmacy Service
- Medical University of South Carolina
- The Neurology and Pain Clinic
- Mid-South Physicians Group, PLLC
- University of Tennessee Lebonheur Pediatric Specialists Inc.
- Access Clinical Trial, Inc.
- CMC - Physician's Park
- Vanderbilt University Medical Center
- Vanderbilt Epilepsy Clinic
- Vanderbilt University Hospital Pharmacy
- Neurological Clinic of Texas, PA
- Cook Children's Medical Center
- Cook Children's Physcian Network
- Cook Children's Medical Center Office of Grants and Research
- Alamo City Clinical Research, LLC
- Virginia Commonwealth University Health System
- Virginia Commonwealth University Division of Child Neurology
- Virginia Commonwealth University Ambulatory Care Center/Department of Neurology
- Harborview Medical Center
- University of Washington Regional Epilepsy Center, Harborview Medical Center
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Placebo
Diazepam
During 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).
During 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.