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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00319501
First received: April 27, 2006
Last updated: June 12, 2014
Last verified: June 2014

April 27, 2006
June 12, 2014
January 2006
December 2011   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00319501 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
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.
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

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Seizures
  • Epilepsies, Partial
  • Epilepsy, Complex Partial
  • Epilepsy, Generalized
  • Epilepsy
  • Drug: Placebo
    Intramuscular autoinjector; vehicle; onset of an episode
  • 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
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
  • Experimental: 1
    Intervention: Drug: Vanquix Auto-Injector (Diazepam Injection)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
234
November 2014
December 2011   (final data collection date for primary outcome measure)

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
Both
2 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00319501
K826-05-3001, B4511001
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP