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. - Full Text View

Sponsor:	Pfizer
Information provided by (Responsible Party):	Pfizer
ClinicalTrials.gov Identifier:	NCT00319501

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: Diazepam	Phase III

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:

Genetics Home Reference related topics: autosomal dominant partial epilepsy with auditory features pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Caregivers Epilepsy Seizures

Drug Information available for: Diazepam

U.S. FDA Resources

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 ]

Estimated Enrollment:	325
Study Start Date:	January 2006
Estimated Study Completion Date:	December 2012
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: Diazepam Intramuscular autoinjector: 5, 10, 15, or 20 mg (based on subject's 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

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

Show 64 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00319501 History of Changes
Other Study ID Numbers:	K826-05-3001, B4511001
Study First Received:	April 27, 2006
Last Updated:	January 24, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Acute Repetitive Seizures
ARS
Diazepam
Cluster Seizures

Additional relevant MeSH terms:

Epilepsy
Epilepsies, Partial
Epilepsy, Generalized
Seizures
Epilepsy, Complex Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Diazepam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

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
Anesthetics

ClinicalTrials.gov processed this record on February 09, 2012