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| Sponsor: | King Pharmaceuticals Research and Development |
|---|---|
| Information provided by: | King Pharmaceuticals Research and Development |
| ClinicalTrials.gov Identifier: | NCT00319501 |
Purpose
The purpose of this study is to determine if there is a difference in the number of seizures and adverse events after a diazepam or placebo injection is given to control acute repetitive seizures.
| Condition | Intervention | Phase |
|---|---|---|
|
Epilepsy Epilepsy, Generalized Epilepsy, Complex Partial Epilepsies, Partial Seizures |
Drug: Diazepam Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 325 |
| Study Start Date: | January 2006 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: Diazepam
Intramuscular autoinjector: 5, 10, 15, or 20 mg (based on subject's weight); onset of an episode
|
| 2: Placebo Comparator |
Drug: Placebo
Intramuscular autoinjector; vehicle; onset of an episode
|
In the United States, more than 2 million people have epilepsy. Most patients with epilepsy are able to control their seizures with drugs and/or surgery. However, many patients (400,000 to greater than 600,000) are considered refractory to antiepileptic drugs and still experience acute repetitive seizures (ARS). An ARS is an episode of multiple seizures that differs from the patient's usual seizure pattern and is often recognizable by the patient's family and caregivers. The ARS is usually described as a bout or cluster of seizures that occurs over a short period of time in which the patient regains consciousness in between seizures. Only one drug is currently available that persons other than health care professionals (e.g., patient's caregiver) may give to control ARS. This drug is called Diastat®. Diastat® is a diazepam rectal gel and, although it is effective, it may be difficult, inconvenient, or objectionable to use because of its rectal administration. Vanquix™ (diazepam autoinjector) also contains diazepam, but is administered by an automated injectable device into the leg muscle. Vanquix™ may be less difficult and more convenient to use by caregivers, however, its effectiveness and safety have not been studied in patients. This study will determine the effectiveness and safety of Vanquix™ compared to placebo for treating ARS.
Eligibility| Ages Eligible for Study: | 2 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Inclusion Criteria for Patient:
Inclusion Criteria for Caregiver(s):
Exclusion Criteria:
Contacts and Locations| Contact: Tim Warneke | 919-653-7006 |
Show 56 Study Locations| Study Director: | Veeru Goli, M.D. | King Pharmaceuticals |
More Information
| Responsible Party: | King Pharmaceuticals, Inc. ( Eric G. Carter, Ph.D., M.D., Chief Science Officer ) |
| Study ID Numbers: | K826-05-3001 |
| Study First Received: | April 27, 2006 |
| Last Updated: | January 14, 2010 |
| ClinicalTrials.gov Identifier: | NCT00319501 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Acute Repetitive Seizures ARS Diazepam Cluster Seizures |
|
Epilepsies, Partial Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action GABA Modulators Physiological Effects of Drugs Psychotropic Drugs Anesthetics Antiemetics Neuromuscular Agents Brain Diseases Epilepsy, Complex Partial Signs and Symptoms Therapeutic Uses Muscle Relaxants, Central Hypnotics and Sedatives |
Anesthetics, Intravenous Tranquilizing Agents Diazepam Nervous System Diseases Seizures Gastrointestinal Agents Central Nervous System Diseases Central Nervous System Depressants Pharmacologic Actions Adjuvants, Anesthesia Anesthetics, General Epilepsy Autonomic Agents GABA Agents Neurologic Manifestations |
