Efficacy and Safety of Diazepam in the Management of Refractory Epilepsy in Selected Patients Who Require Intermittent Medical Intervention for Acute Repetitive Seizures.
- Conditions
- SeizuresEpilepsies, PartialEpilepsy, Complex PartialEpilepsy, GeneralizedEpilepsy
- Interventions
- Drug: PlaceboDrug: Vanquix Auto-Injector (Diazepam Injection)
- Registration Number
- NCT00319501
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 234
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo 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). Diazepam Vanquix Auto-Injector (Diazepam Injection) 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.
- Primary Outcome Measures
Name Time Method Time to Next Seizure or Rescue Medication During the Double-blind Period (Kaplan-Meier 50th Percentile) From 15 minutes to 12 hours after study drug administration for an episode of ARS during the Double-blind 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.
Percentage of Participants With an Event (Next Seizure or Rescue Medication) During the Open-label Period From 15 minutes to 12 hours after study drug administration for an episode of ARS during the Double-blind 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.
- Secondary Outcome Measures
Name Time Method 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 Caregiver global evaluation is based on seizure frequency, severity, and overall outcome compared with previous episodes and is rated on a 10-cm visual analogue scale, where 0=much worse and 10=much better. A higher score indicates greater improvement. An episode of acute repetitive seizures (ARS) is defined as an episode of multiple complex, partial, or generalized seizures occurring over a brief period (minutes to 12 hours) with the patient regaining consciousness between seizures, which were readily recognizable by the patient or a trained caregiver. ARS includes seizures sometimes referred to as serial, cluster, crescendo, or stuttering prolonged.
Mean Score on Physician Global Treatment Assessment During the Double-blind Period At Visit 2 and subsequent visits in the Double-blind Period Physician global evaluation is based on seizure frequency, severity, and overall outcome compared with previous episodes. The physician global evaluation is rated on a 10-cm visual analogue scale, where 0=much worse and 10=much better. A higher score indicates greater improvement. An episode of acute repetitive seizures (ARS) was defined as an episode of multiple complex, partial, or generalized seizures occurring over a brief period (minutes to 12 hours) with the patient regaining consciousness between seizures, which were readily recognizable by the patient or a trained caregiver. ARS includes seizures sometimes referred to as serial, cluster, crescendo, or stuttering prolonged.
Number of Participants Requiring Rescue Medical Care Other Than Medication or Emergency Department Visits During the Open-label Period From 15 minutes to 12 hours after study drug administration for onset of an episode of ARS during the Open-label Period Other rescue medical care consisted of care other than rescue medication or emergency department visits. Each patient's specific criteria for seizure and an episode of acute repetitive seizure (ARS) were determined by the Investigator. Patients and their caregivers were trained to use these criteria to recognize the onset of an episode of ARS and when and how to administer study drug.
Mean Score on Caregiver Global Treatment Assessment During the Open-label Period Assessments completed at the end of each treated episode of ARS in the Open-label Period Caregiver global evaluation is based on seizure frequency, severity, and overall outcome compared with previous episodes and is rated on a 10-cm visual analogue scale, where 0=much worse and 10=much better. A higher score indicates greater improvement. An episode of acute repetitive seizures (ARS) is defined as an episode of multiple complex, partial, or generalized seizures occurring over a brief period (minutes to 12 hours) with the patient regaining consciousness between seizures, which were readily recognizable by the patient or a trained caregiver. ARS includes seizures sometimes referred to as serial, cluster, crescendo, or stuttering prolonged.
Mean Score on Physician Global Treatment Assessment During the Open-label Period From Visit 2 and subsequent visits in the Open-label Period to discharge or study termination Physician global evaluation is based on seizure frequency, severity, and overall outcome compared with previous episodes and is rated on a 10-cm visual analogue scale, where 0=much worse and 10=much better. A higher score indicates greater improvement. An episode of acute repetitive seizures (ARS) is defined as an episode of multiple complex, partial, or generalized seizures occurring over a brief period (minutes to 12 hours) with the patient regaining consciousness between seizures, which were readily recognizable by the patient or a trained caregiver. ARS includes seizures sometimes referred to as serial, cluster, crescendo, or stuttering prolonged.
Number of Participants Requiring Rescue Medication During the Open-label Period From 15 minutes to 12 hours after study drug administration during the Open-label Period Each patient's specific criteria for seizure and an episode of acute repetitive seizure (ARS) were determined by the Investigator. Patients and their caregivers were trained to use these criteria to recognize the onset of an episode of ARS and when and how to administer study drug. 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.
Number of Participants Requiring Emergency Department Visits During the Open-label Period From 15 minutes to 12 hours after study drug administration for onset of an episode of ARS during the Open-label Period Any use of emergency treatment (such as an emergency room visit) was recorded in the patient's diary, along with the date, time, and reason for the emergency treatment. Emergency department visits required some type of rescue action taken, other than the visit itself.
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 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 acute repetitive seizure (ARS) episode. Each patient's specific criteria for seizure and an episode of ARS were determined by the Investigator. Patients and their caregivers were trained to use these criteria to recognize the onset of an episode of ARS and when and how to administer study drug. An episode of ARS was defined as an episode of multiple complex, partial, or generalized seizures occurring over a brief period (minutes to 12 hours) with the patient regaining consciousness between seizures, which were readily recognizable by the patient or a trained caregiver. ARS includes seizures sometimes referred to as serial, cluster, crescendo, or stuttering prolonged.
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 Any use of emergency treatment (such as an emergency room visit) was recorded in the patient's diary, along with the date, time, and reason for the emergency treatment. Emergency department visits required some type of rescue action taken, other than the visit itself. An episode of acute repetitive seizures (ARS) was defined as an episode of multiple complex, partial, or generalized seizures occurring over a brief period (minutes to 12 hours) with the patient regaining consciousness between seizures, which were readily recognizable by the patient or a trained caregiver. ARS includes seizures sometimes referred to as serial, cluster, crescendo, or stuttering prolonged.
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 Other rescue medical care consisted of care other than rescue medication or emergency department visits. Each patient's specific criteria for seizure and an episode of acute repetitive seizure (ARS) were determined by the Investigator. Patients and their caregivers were trained to use these criteria to recognize the onset of an episode of ARS and when and how to administer study drug. An episode of ARS was defined as an episode of multiple complex, partial, or generalized seizures occurring over a brief period (minutes to 12 hours) with the patient regaining consciousness between seizures, which were readily recognizable by the patient or a trained caregiver. ARS includes seizures sometimes referred to as serial, cluster, crescendo, or stuttering prolonged.
Trial Locations
- Locations (85)
Stein Life Child Neurology Medical Specialists Inc.
🇺🇸Irvine, California, United States
Lahey Clinic Medical Center
🇺🇸Burlington, Massachusetts, United States
Morton Plant Hospital Pharmacy
🇺🇸Clearwater, Florida, United States
Morton Plant Hospital Epilepsy Clinic
🇺🇸Clearwater, Florida, United States
Consultants in Epilepsy and Neurology, PLLC
🇺🇸Boise, Idaho, United States
University of Medicine and Dentistry of New Jersey Robert Wood Johnson Medical Group
🇺🇸New Brunswick, New Jersey, United States
Neurology Clinic, PC
🇺🇸Northport, Alabama, United States
Elmwood Clinic
🇺🇸Buffalo, New York, United States
Pediatric Neurology and Epilepsy Center
🇺🇸Loxahatchee, Florida, United States
Savannah Neurology, PC
🇺🇸Savannah, Georgia, United States
University of Chicago Medical Center (UCMC)
🇺🇸Chicago, Illinois, United States
Neurology Clinic of St Cloud
🇺🇸St Cloud, Minnesota, United States
Bradenton Research Center, Inc.
🇺🇸Bradenton, Florida, United States
Clinical Trials, Inc
🇺🇸Little Rock, Arkansas, United States
Child Neurology Center of NorthWest Florida
🇺🇸Gulf Breeze, Florida, United States
Emery Neuroscience Center
🇺🇸Lighthouse Point, Florida, United States
NYU Medical Center, Comprehensive Epilepsy Center
🇺🇸New York, New York, United States
Cook Children's Physcian Network
🇺🇸Fort Worth, Texas, United States
The Comprehensive Epilepsy Care Center For Children and Adults
🇺🇸Chesterfield, Missouri, United States
University of Tennessee Lebonheur Pediatric Specialists Inc.
🇺🇸Memphis, Tennessee, United States
Clinical Research Center of New Jersey
🇺🇸Gibbsboro, New Jersey, United States
The Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
The Neurology and Pain Clinic
🇺🇸Orangeburg, South Carolina, United States
Cook Children's Medical Center Office of Grants and Research
🇺🇸Ft Worth, Texas, United States
Miami Children's Hospital
🇺🇸Miami, Florida, United States
Child Neurology Associates, PC
🇺🇸Atlanta, Georgia, United States
Comer Children's Hospital
🇺🇸Chicago, Illinois, United States
University of Chicago Hospital Pharmacy
🇺🇸Chicago, Illinois, United States
The Cleveland Clinic Health Systems
🇺🇸Cleveland, Ohio, United States
Ohio State University Neurology Clinic
🇺🇸Columbus, Ohio, United States
Ohio State University University Hospital
🇺🇸Columbus, Ohio, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
University of Washington Regional Epilepsy Center, Harborview Medical Center
🇺🇸Seattle, Washington, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Hoag Memorial Hospital Presbyterian
🇺🇸Newport Beach, California, United States
North Pacific Epilepsy Research/The Northrup Center
🇺🇸Portland, Oregon, United States
Access Clinical Trial, Inc.
🇺🇸Nashville, Tennessee, United States
CMC - Physician's Park
🇺🇸Nashville, Tennessee, United States
Vanderbilt Epilepsy Clinic
🇺🇸Nashville, Tennessee, United States
Vanderbilt University Hospital Pharmacy
🇺🇸Nashville, Tennessee, United States
Alamo City Clinical Research, LLC
🇺🇸San Antonio, Texas, United States
AMO Corp
🇺🇸Tallahassee, Florida, United States
Wellspan Neurosciences
🇺🇸York, Pennsylvania, United States
Collaborative NeuroScience Network, LLC
🇺🇸Long Beach, California, United States
Brain and Spine Surgeons of Orange County
🇺🇸Newport Beach, California, United States
NorthWest Florida Clinical Research Group, LLC
🇺🇸Gulf Breeze, Florida, United States
Tallahassee Neurological Clinic
🇺🇸Tallahassee, Florida, United States
University of Chicago Medical Center (UCMC) Center for Advanced Medicine (CAM)
🇺🇸Chicago, Illinois, United States
University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School
🇺🇸New Brunswick,, New Jersey, United States
Women and Children's Hospital of Buffalo
🇺🇸Buffalo, New York, United States
Strong Memorial Hospital
🇺🇸Rochester, New York, United States
Cone Health Child Neurology
🇺🇸Greensboro, North Carolina, United States
University of Rochester, Strong Epilepsy Center
🇺🇸Rochester, New York, United States
Guilford Neurologic Associates
🇺🇸Greensboro, North Carolina, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
St. Christopher's Hospital for Children
🇺🇸Philadelphia, Pennsylvania, United States
Apple Hill Medical Center (EKG & Lab Draw)
🇺🇸York, Pennsylvania, United States
Mid-South Physicians Group, PLLC
🇺🇸Germantown, Tennessee, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Neurological Clinic of Texas, PA
🇺🇸Dallas, Texas, United States
Cook Children's Medical Center
🇺🇸Fort Worth, Texas, United States
Millard Fillmore Gates Hospital/Comprehensive Epilepsy Center
🇺🇸Buffalo, New York, United States
Raleigh Neurology Associates, PA
🇺🇸Raleigh, North Carolina, United States
Drug Shipment
🇺🇸Sacramento, California, United States
Sacramento Comprehensive Epilepsy Program
🇺🇸Sacramento, California, United States
Sutter Institute for Medical Research
🇺🇸Sacramento, California, United States
Sutter Cancer Center Specialty Clinic
🇺🇸Sacramento, California, United States
Northern California Cardiology
🇺🇸Sacramento, California, United States
EKG only
🇺🇸Orlando, Florida, United States
Pediatric Neurology, PA
🇺🇸Orlando, Florida, United States
University Neurologists PSC Pediatric Division
🇺🇸Louisville, Kentucky, United States
Pediatric Epilepsy & Neurology Specialists
🇺🇸Tampa, Florida, United States
Willsey Research Inc
🇺🇸Tampa, Florida, United States
University of Louisville Ambulatory Care Building Clinic
🇺🇸Louisville, Kentucky, United States
University of Louisville Clinical Trials Unit
🇺🇸Louisville, Kentucky, United States
MRI Location
🇺🇸Kansas City, Missouri, United States
St Luke's Hospital Neurological Consultants
🇺🇸Kansas City, Missouri, United States
St Luke's Hospital
🇺🇸Kansas City, Missouri, United States
Medical University of South Carolina Hospitals and Clinics
🇺🇸Charleston, South Carolina, United States
Medical University of South Carolina/Department of Pharmacy Service
🇺🇸Charleston, South Carolina, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Virginia Commonwealth University Health System
🇺🇸Richmond, Virginia, United States
Virginia Commonwealth University Division of Child Neurology
🇺🇸Richmond, Virginia, United States
Virginia Commonwealth University Ambulatory Care Center/Department of Neurology
🇺🇸Richmond, Virginia, United States