A Phase 3, Randomized, Double Blind, Parallel, Placebo Controlled, Multicenter Study, with Optional Open Label Continuation, of the Efficacy and safety of Vanquix™ Auto Injector (Diazepam Injection)...

Sponsor: King Pharmaceuticals, Inc.

Purpose of Study

• To evaluate the efficacy of Vanquix™ for the management of selected, refractory, patients with epilepsy who require intermittent medical intervention provided by caregivers to control episodes of acute repetitive seizures (ARS).
  
  
• To evaluate the safety of Vanquix™ when administered to selected, refractory, patients with epilepsy 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.

Study Description
A Phase 3, Randomized, Double Blind, Parallel, Placebo Controlled, Multicenter Study, with Optional Open Label Continuation, of the Efficacy and Safety 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.

Study Qualifications

• Age range for subjects: Is ≥2 years of age
• Seizure type(s): Has episodes of ARS that include partial or generalized seizures that are readily clinically identifiable by the caregiver. Note: Simple partial motor seizures qualify if they are clinically recognized as seizures.
• Seizure frequency limit (or none): Has experienced at least 2 episodes of repetitive seizures in the year prior to enrollment, one of which must have occurred in the previous 6 months.
• Number of current antiepileptic drugs limit (or none): None / stable for 2 weeks
• Number of previous antiepileptic drugs limit (or none): None
• Concomitant medications not allowed (or none): Rescue Benzodiazepine 7 days before study drug.
• Concomitant medical disorders not allowed (or none):
  • Has a history of consistent progression from episodes of ARS to status epilepticus
  • Has acute narrow angle glaucoma.

Study Approvals
IRB approval number: WSH-IRB 0607031
IRB approval ending date: 14 November 2008

Study Design/Interventions

• Investigational medication(s): Diazepam Injection
• Investigational device: Not applicable
• FDA-approved antiepileptic drug(s): Not applicable
• FDA-approved device: Not applicable
• Control group intervention: Not applicable
• Duration of Study: 18 months
• Baseline period: 6 months
• Follow-up period: Not applicable
• Open Label or double blind: 1 year
• Randomized, sequetial, other: Randomized
• Inpatient, outpatient or both: Outpatient
• Number of visits required: every time you use the injection

Costs / Payments:

• Medications provided at no cost to subjects: YES
• Examinations and lab tests provided at no cost to subjects: YES
• Reimbursement of parking and transportation cost to subjects: NO
• Study payments to subjects: YES
• Costs to subjects: None
• Payment to subjects: Approximately $50 a visit

Contact:
Yong Park
Medical College of Georgia, Department of Neurology
Located in: Augusta, GA 30912
Telephone: (706) 721-3371

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