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.

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00319501
• Other study ID #: K826-05-3001
• Secondary ID: B4511001
• Status: Completed
• Phase: Phase 3
• First received: April 27, 2006
• Last updated: August 6, 2014
• Start date: January 2006
• Est. completion date: July 2014

Study information

• Verified date: August 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Other known NCT identifiers

• NCT01079156

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: July 2014
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy
• Epilepsy, Complex Partial
• Epilepsy, Generalized
• Seizures

Intervention

Drug:
• Placebo
Intramuscular autoinjector; vehicle; onset of an episode
• Vanquix Auto-Injector (Diazepam Injection)
Intramuscular autoinjector: 5, 10, 15, or 20 mg (based on subject's age and weight); onset of an episode

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Boise	Idaho
United States	Pfizer Investigational Site	Bradenton	Florida
United States	Pfizer Investigational Site	Buffalo	New York
United States	Pfizer Investigational Site	Buffalo	New York
United States	Pfizer Investigational Site	Buffalo	New York
United States	Pfizer Investigational Site	Burlington	Massachusetts
United States	Pfizer Investigational Site	Charleston	South Carolina
United States	Pfizer Investigational Site	Chesterfield	Missouri
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Clearwater	Florida
United States	Pfizer Investigational Site	Cleveland	Ohio
United States	Pfizer Investigational Site	Cleveland	Ohio
United States	Pfizer Investigational Site	Columbus	Ohio
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Fort Lauderdale	Florida
United States	Pfizer Investigational Site	Fort Worth	Texas
United States	Pfizer Investigational Site	Germantown	Tennessee
United States	Pfizer Investigational Site	Gibbsboro	New Jersey
United States	Pfizer Investigational Site	Greensboro	North Carolina
United States	Pfizer Investigational Site	Gulf Breeze	Florida
United States	Pfizer Investigational Site	Irvine	California
United States	Pfizer Investigational Site	Kansas City	Missouri
United States	Pfizer Investigational Site	Lebanon	New Hampshire
United States	Pfizer Investigational Site	Lighthouse Point	Florida
United States	Pfizer Investigational Site	Little Rock	Arkansas
United States	Pfizer Investigational Site	Long Beach	California
United States	Pfizer Investigational Site	Louisville	Kentucky
United States	Pfizer Investigational Site	Loxahatchee	Florida
United States	Pfizer Investigational Site	Memphis	Tennessee
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Nashville	Tennessee
United States	Pfizer Investigational Site	Nashville	Tennessee
United States	Pfizer Investigational Site	New Brunswick	New Jersey
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	New York	Pennsylvania
United States	Pfizer Investigational Site	Newport Beach	California
United States	Pfizer Investigational Site	Newport Beach	California
United States	Pfizer Investigational Site	Northport	Alabama
United States	Pfizer Investigational Site	Orangeburg	South Carolina
United States	Pfizer Investigational Site	Orlando	Florida
United States	Pfizer Investigational Site	Orlando	Florida
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Raleigh	North Carolina
United States	Pfizer Investigational Site	Richmond	Virginia
United States	Pfizer Investigational Site	Richmond	Virginia
United States	Pfizer Investigational Site	Richmond	Virginia
United States	Pfizer Investigational Site	Rochester	New York
United States	Pfizer Investigational Site	Sacramento	California
United States	Pfizer Investigational Site	Sacramento	California
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	Savannah	Georgia
United States	Pfizer Investigational Site	Seattle	Washington
United States	Pfizer Investigational Site	Seattle	Washington
United States	Pfizer Investigational Site	St. Cloud	Minnesota
United States	Pfizer Investigational Site	Tallahassee	Florida
United States	Pfizer Investigational Site	Tampa	Florida
United States	Pfizer Investigational Site	Tampa	Florida
United States	Pfizer Investigational Site	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to next seizure or rescue beginning at least 15 minutes after and within 12-hours of study drug administration (Vanquix or placebo).		15 minutes - 2 hours post dose	No
Secondary	Number (%) of patients requiring rescue medication after treatment with study drug		post-dose	No
Secondary	Number (%) of patients requiring emergency room visits after treatment with study drug.		post-dose	No
Secondary	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).		post-dose	No
Secondary	Physician global evaluations of treatment outcome will be rated on a 10 cm VAS.		post-dose	No

External Links

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