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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

  Show 62 Study Locations
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:
Epilepsies, Partial
Epilepsy
Epilepsy, Complex Partial
Epilepsy, Generalized
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Diazepam
Adjuvants, Anesthesia
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Anti-Anxiety Agents
Anticonvulsants
Antiemetics
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Modulators
Gastrointestinal Agents
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Muscle Relaxants, Central
Neuromuscular Agents
Neurotransmitter Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on November 20, 2014