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

Primary Purpose

Seizures, Epilepsies, Partial, Epilepsy, Complex Partial

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Placebo
Vanquix Auto-Injector (Diazepam Injection)
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seizures focused on measuring Acute Repetitive Seizures, ARS, Diazepam, Cluster Seizures

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Diazepam

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Number of Participants Requiring Rescue Medication 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
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
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.
Mean Score on Caregiver Global Treatment Assessment During 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
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 Medication 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
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 Medical Care Other Than Medication or Emergency Department Visits 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
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
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.

Full Information

First Posted
April 27, 2006
Last Updated
August 17, 2016
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00319501
Brief Title
Efficacy and Safety of Diazepam in the Management of Refractory Epilepsy in Selected Patients Who Require Intermittent Medical Intervention for Acute Repetitive Seizures.
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seizures, Epilepsies, Partial, Epilepsy, Complex Partial, Epilepsy, Generalized, Epilepsy
Keywords
Acute Repetitive Seizures, ARS, Diazepam, Cluster Seizures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
234 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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).
Arm Title
Diazepam
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intramuscular autoinjector; administered at onset of an episode
Intervention Type
Drug
Intervention Name(s)
Vanquix Auto-Injector (Diazepam Injection)
Intervention Description
Intramuscular autoinjector: 5, 10, 15, or 20 mg (based on participant's age and weight); administered at the onset of an episode
Primary Outcome Measure Information:
Title
Time to Next Seizure or Rescue Medication During the Double-blind Period (Kaplan-Meier 50th Percentile)
Description
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.
Time Frame
From 15 minutes to 12 hours after study drug administration for an episode of ARS during the Double-blind Period
Title
Percentage of Participants With an Event (Next Seizure or Rescue Medication) During the Open-label Period
Description
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.
Time Frame
From 15 minutes to 12 hours after study drug administration for an episode of ARS during the Double-blind Period
Secondary Outcome Measure Information:
Title
Number of Participants Requiring Rescue Medication During the Double-blind Period
Description
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.
Time Frame
From 15 minutes to 12 hours following study drug administration for an episode of ARS during the Double-blind Period
Title
Number of Participants Requiring Emergency Department Visits During the Double-blind Period
Description
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.
Time Frame
From 15 minutes to 12 hours following study drug administration for onset of an episode of ARS during the Double-blind Period
Title
Number of Participants Requiring Rescue Medical Care Other Than Rescue Medication or Emergency Department Visits During the Double-blind Period
Description
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.
Time Frame
From 15 minutes to 12 hours following study drug administration for an episode of ARS during the Double-blind Period
Title
Mean Score on Caregiver Global Treatment Assessment During the Double-blind Period
Description
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.
Time Frame
Assessments completed at the end of each treated episode of ARS in the Double-blind Period
Title
Mean Score on Physician Global Treatment Assessment During the Double-blind Period
Description
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.
Time Frame
At Visit 2 and subsequent visits in the Double-blind Period
Title
Number of Participants Requiring Rescue Medication During the Open-label Period
Description
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.
Time Frame
From 15 minutes to 12 hours after study drug administration during the Open-label Period
Title
Number of Participants Requiring Emergency Department Visits During the Open-label Period
Description
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.
Time Frame
From 15 minutes to 12 hours after study drug administration for onset of an episode of ARS during the Open-label Period
Title
Number of Participants Requiring Rescue Medical Care Other Than Medication or Emergency Department Visits During the Open-label Period
Description
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.
Time Frame
From 15 minutes to 12 hours after study drug administration for onset of an episode of ARS during the Open-label Period
Title
Mean Score on Caregiver Global Treatment Assessment During the Open-label Period
Description
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.
Time Frame
Assessments completed at the end of each treated episode of ARS in the Open-label Period
Title
Mean Score on Physician Global Treatment Assessment During the Open-label Period
Description
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.
Time Frame
From Visit 2 and subsequent visits in the Open-label Period to discharge or study termination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Neurology Clinic, PC
City
Northport
State/Province
Alabama
ZIP/Postal Code
35476
Country
United States
Facility Name
Clinical Trials, Inc
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Stein Life Child Neurology Medical Specialists Inc.
City
Irvine
State/Province
California
ZIP/Postal Code
92606
Country
United States
Facility Name
Collaborative NeuroScience Network, LLC
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Hoag Memorial Hospital Presbyterian
City
Newport Beach
State/Province
California
ZIP/Postal Code
92658
Country
United States
Facility Name
Brain and Spine Surgeons of Orange County
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Drug Shipment
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Sacramento Comprehensive Epilepsy Program
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Sutter Cancer Center Specialty Clinic
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Sutter Institute for Medical Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Northern California Cardiology
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Bradenton Research Center, Inc.
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
Morton Plant Hospital Epilepsy Clinic
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Morton Plant Hospital Pharmacy
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Child Neurology Center of NorthWest Florida
City
Gulf Breeze
State/Province
Florida
ZIP/Postal Code
32561
Country
United States
Facility Name
NorthWest Florida Clinical Research Group, LLC
City
Gulf Breeze
State/Province
Florida
ZIP/Postal Code
32561
Country
United States
Facility Name
Emery Neuroscience Center
City
Lighthouse Point
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
Pediatric Neurology and Epilepsy Center
City
Loxahatchee
State/Province
Florida
ZIP/Postal Code
33470
Country
United States
Facility Name
Miami Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
EKG only
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Pediatric Neurology, PA
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Facility Name
AMO Corp
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Tallahassee Neurological Clinic
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Pediatric Epilepsy & Neurology Specialists
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Willsey Research Inc
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Child Neurology Associates, PC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Savannah Neurology, PC
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Consultants in Epilepsy and Neurology, PLLC
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Comer Children's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Chicago Hospital Pharmacy
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Chicago Medical Center (UCMC) Center for Advanced Medicine (CAM)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Chicago Medical Center (UCMC)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University Neurologists PSC Pediatric Division
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Louisville Ambulatory Care Building Clinic
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Louisville Clinical Trials Unit
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Lahey Clinic Medical Center
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Neurology Clinic of St Cloud
City
St Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Facility Name
The Comprehensive Epilepsy Care Center For Children and Adults
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
MRI Location
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
St Luke's Hospital Neurological Consultants
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
St Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Clinical Research Center of New Jersey
City
Gibbsboro
State/Province
New Jersey
ZIP/Postal Code
08026
Country
United States
Facility Name
University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School
City
New Brunswick,
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
University of Medicine and Dentistry of New Jersey Robert Wood Johnson Medical Group
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Elmwood Clinic
City
Buffalo
State/Province
New York
ZIP/Postal Code
14207
Country
United States
Facility Name
Millard Fillmore Gates Hospital/Comprehensive Epilepsy Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14209
Country
United States
Facility Name
Women and Children's Hospital of Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14222
Country
United States
Facility Name
NYU Medical Center, Comprehensive Epilepsy Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Strong Memorial Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
University of Rochester, Strong Epilepsy Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Cone Health Child Neurology
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Guilford Neurologic Associates
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States
Facility Name
Raleigh Neurology Associates, PA
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195-5102
Country
United States
Facility Name
The Cleveland Clinic Health Systems
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195-5102
Country
United States
Facility Name
Ohio State University Neurology Clinic
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Ohio State University University Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
North Pacific Epilepsy Research/The Northrup Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
St. Christopher's Hospital for Children
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19134-1095
Country
United States
Facility Name
St. Christopher's Hospital for Children
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19134
Country
United States
Facility Name
Wellspan Neurosciences
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17402
Country
United States
Facility Name
Apple Hill Medical Center (EKG & Lab Draw)
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17403
Country
United States
Facility Name
Medical University of South Carolina Hospitals and Clinics
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Medical University of South Carolina/Department of Pharmacy Service
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
The Neurology and Pain Clinic
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
Mid-South Physicians Group, PLLC
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
University of Tennessee Lebonheur Pediatric Specialists Inc.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Facility Name
Access Clinical Trial, Inc.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
CMC - Physician's Park
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-2551
Country
United States
Facility Name
Vanderbilt Epilepsy Clinic
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Vanderbilt University Hospital Pharmacy
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Neurological Clinic of Texas, PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Cook Children's Medical Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Cook Children's Physcian Network
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Cook Children's Medical Center Office of Grants and Research
City
Ft Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Alamo City Clinical Research, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Virginia Commonwealth University Health System
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0042
Country
United States
Facility Name
Virginia Commonwealth University Division of Child Neurology
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0211
Country
United States
Facility Name
Virginia Commonwealth University Ambulatory Care Center/Department of Neurology
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0599
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
University of Washington Regional Epilepsy Center, Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24111974
Citation
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. Erratum In: Epilepsia. 2018 Dec;59(12):2344.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=K826-05-3001&StudyName=Efficacy%20and%20safety%20of%20Vanquix%20for%20the%20management%20of%20selected%2C%20refractory%2C%20patients%20with%20epilepsy%20who%20require%20intermittent%20caregiver
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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