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 currently recruiting participants.
Verified April 2013 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00319501
First received: April 27, 2006
Last updated: April 29, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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:
Genetics Home Reference related topics:
autosomal dominant partial epilepsy with auditory features
pyridoxal 5'-phosphate-dependent epilepsy
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: | 234 |
| Study Start Date: | January 2006 |
| Estimated Study Completion Date: | July 2013 |
| 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 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 60 Study Locations
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Show 60 Study LocationsSponsors 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: | April 29, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Acute Repetitive Seizures ARS Diazepam Cluster Seizures |
Additional relevant MeSH terms:
|
Anticonvulsants Epilepsy Epilepsies, Partial Epilepsy, Generalized Seizures Epilepsy, Complex Partial Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms Diazepam 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 May 16, 2013