Efficacy and Safety of Vanquix for the Management of Selected, Refractory, Patients With Epilepsy Who Require Intermittent Caregiver Medical Intervention to Control Episodes of Acute Repetitive Seizures.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00319501
First received: April 27, 2006
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

To evaluate the efficacy and safety of Vanquix for the management of selected, refractory, patients with epilepsy who require intermittent medical intervention provided by caregivers who are not health care professionals, and who are not under the direct supervision of a healthcare professional at the time of administration to control episodes of acute repetitive seizures (ARS).


Condition Intervention Phase
Seizures
Epilepsies, Partial
Epilepsy, Complex Partial
Epilepsy, Generalized
Epilepsy
Drug: Placebo
Drug: Vanquix Auto-Injector (Diazepam Injection)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized Double-Blind, Parallel, Placebo-Controlled, Multicenter Study, With Optional Open-Label Continuation, of the Safety and Efficacy of Vanquix 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Time to next seizure or rescue beginning at least 15 minutes after and within 12-hours of study drug administration (Vanquix or placebo). [ Time Frame: 15 minutes - 2 hours post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number (%) of patients requiring rescue medication after treatment with study drug [ Time Frame: post-dose ] [ Designated as safety issue: No ]
  • Number (%) of patients requiring emergency room visits after treatment with study drug. [ Time Frame: post-dose ] [ Designated as safety issue: No ]
  • Caregiver global evaluations of treatment outcome, based on seizure frequency, severity, and overall outcome compared to previous episodes. The caregiver global evaluation will be rated on a 10 cm visual analog scale (VAS). [ Time Frame: post-dose ] [ Designated as safety issue: No ]
  • Physician global evaluations of treatment outcome will be rated on a 10 cm VAS. [ Time Frame: post-dose ] [ Designated as safety issue: No ]

Enrollment: 234
Study Start Date: January 2006
Study Completion Date: July 2014
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 2 Drug: Placebo
Intramuscular autoinjector; vehicle; onset of an episode
Experimental: 1 Drug: Vanquix Auto-Injector (Diazepam Injection)
Intramuscular autoinjector: 5, 10, 15, or 20 mg (based on subject's age and weight); onset of an episode

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Inclusion Criteria for Patient:

  • Clinical diagnosis of epilepsy, on a stable antiepileptic drug (AED) regimen for at least 2 weeks, and requires 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 and not lactating and is practicing an acceptable method of birth control

Inclusion Criteria for Caregiver(s):

  • Is 18 years of age or older and is responsible
  • Is available to accompany the patient to clinic visits

Exclusion Criteria:

  • Petit mal status or petit mal variant status
  • History of ARS consistently progressing to status epilepticus
  • Has history of failure to respond to benzodiazepine treatment
  • Hypersensitive to diazepam
  • Acute narrow angle glaucoma
  • Abuses alcohol and/or other substances
  • Took another investigational drug in previous 30 days
  • Acute or progressive neurological disease, severe psychiatric disease, or severe mental abnormality
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00319501

  Hide Study Locations
Locations
United States, Alabama
Pfizer Investigational Site
Northport, Alabama, United States, 35476
United States, Arkansas
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
Pfizer Investigational Site
Irvine, California, United States, 92606
Pfizer Investigational Site
Long Beach, California, United States, 90806
Pfizer Investigational Site
Newport Beach, California, United States, 92658
Pfizer Investigational Site
Newport Beach, California, United States, 92663
Pfizer Investigational Site
Sacramento, California, United States, 95819
Pfizer Investigational Site
Sacramento, California, United States, 95816
United States, Florida
Pfizer Investigational Site
Bradenton, Florida, United States, 34205
Pfizer Investigational Site
Clearwater, Florida, United States, 33756
Pfizer Investigational Site
Fort Lauderdale, Florida, United States, 33308
Pfizer Investigational Site
Gulf Breeze, Florida, United States, 32561
Pfizer Investigational Site
Lighthouse Point, Florida, United States, 33064
Pfizer Investigational Site
Loxahatchee, Florida, United States, 33470
Pfizer Investigational Site
Miami, Florida, United States, 33155
Pfizer Investigational Site
Orlando, Florida, United States, 32806
Pfizer Investigational Site
Orlando, Florida, United States, 32819
Pfizer Investigational Site
Tallahassee, Florida, United States, 32308
Pfizer Investigational Site
Tampa, Florida, United States, 33613
Pfizer Investigational Site
Tampa, Florida, United States, 33609
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30342
Pfizer Investigational Site
Savannah, Georgia, United States, 31405
United States, Idaho
Pfizer Investigational Site
Boise, Idaho, United States, 83702
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60637
United States, Kentucky
Pfizer Investigational Site
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Pfizer Investigational Site
Burlington, Massachusetts, United States, 01805
United States, Minnesota
Pfizer Investigational Site
St. Cloud, Minnesota, United States, 56303
United States, Missouri
Pfizer Investigational Site
Chesterfield, Missouri, United States, 63017
Pfizer Investigational Site
Kansas City, Missouri, United States, 64111
United States, New Hampshire
Pfizer Investigational Site
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Pfizer Investigational Site
Gibbsboro, New Jersey, United States, 08026
Pfizer Investigational Site
New Brunswick, New Jersey, United States, 08901
United States, New York
Pfizer Investigational Site
Buffalo, New York, United States, 14209
Pfizer Investigational Site
Buffalo, New York, United States, 14222
Pfizer Investigational Site
Buffalo, New York, United States, 14207
Pfizer Investigational Site
New York, New York, United States, 10016
Pfizer Investigational Site
Rochester, New York, United States, 14642
United States, North Carolina
Pfizer Investigational Site
Greensboro, North Carolina, United States, 27405
Pfizer Investigational Site
Raleigh, North Carolina, United States, 27607
United States, Ohio
Pfizer Investigational Site
Cleveland, Ohio, United States, 44195-5102
Pfizer Investigational Site
Cleveland, Ohio, United States, 44195
Pfizer Investigational Site
Columbus, Ohio, United States, 43210
United States, Oregon
Pfizer Investigational Site
Portland, Oregon, United States, 97210
United States, Pennsylvania
Pfizer Investigational Site
New York, Pennsylvania, United States, 17403
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19134
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19134-1095
Pfizer Investigational Site
York, Pennsylvania, United States, 17402
United States, South Carolina
Pfizer Investigational Site
Charleston, South Carolina, United States, 29425
Pfizer Investigational Site
Orangeburg, South Carolina, United States, 29118
United States, Tennessee
Pfizer Investigational Site
Germantown, Tennessee, United States, 38138
Pfizer Investigational Site
Memphis, Tennessee, United States, 38103
Pfizer Investigational Site
Nashville, Tennessee, United States, 37203
Pfizer Investigational Site
Nashville, Tennessee, United States, 37215
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75230
Pfizer Investigational Site
Fort Worth, Texas, United States, 76104
Pfizer Investigational Site
San Antonio, Texas, United States, 78258
United States, Virginia
Pfizer Investigational Site
Richmond, Virginia, United States, 23298-0211
Pfizer Investigational Site
Richmond, Virginia, United States, 23298-0599
Pfizer Investigational Site
Richmond, Virginia, United States, 23298-0042
United States, Washington
Pfizer Investigational Site
Seattle, Washington, United States, 98104-2499
Pfizer Investigational Site
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00319501     History of Changes
Obsolete Identifiers: NCT01079156
Other Study ID Numbers: K826-05-3001, B4511001
Study First Received: April 27, 2006
Last Updated: August 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Acute Repetitive Seizures
ARS
Diazepam
Cluster Seizures

Additional relevant MeSH terms:
Seizures
Epilepsy
Epilepsies, Partial
Epilepsy, Complex Partial
Epilepsy, Generalized
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Diazepam
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anticonvulsants
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Muscle Relaxants, Central
Neuromuscular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General

ClinicalTrials.gov processed this record on September 18, 2014