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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


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
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