A Phase 3, Randomized, Double-blind, Parallel, Placebo-controlled, Multicenter Study, With Optional Open-label Continuation, Of The Efficacy And Safety Of Vanquix(tm) 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
A Phase 3, Randomized, Double-blind, Parallel, Placebo-controlled, Multicenter Study, With Optional Open-label Continuation, Of The Efficacy And Safety Of Vanquix(tm) 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
To evaluate the efficacy and safety of diazepam in the management of refractory epilepsy in selected patients who require intermittent medical intervention for the control of episodes of acute repetitive seizures. In addition, to assess the support provided by caregivers who are not themselves or not under the direct supervision of health care professionals at the time of administration.
Key Inclusion Criteria
For Patient:
For Caregiver:
Age of 18 years or older and has demonstrated responsibility as a caregiver through training to:
Key Exclusion Criteria
For Patient:
Chicago, Illinois 60637, United States
Chesterfield, Missouri 63017, United States
New Brunswick, New Jersey 08901, United States
New Brunswick, New Jersey 08901, United States
Charleston, South Carolina 29425, United States
Charleston, South Carolina 29425, United States
Richmond, Virginia 23298-0211, United States
Richmond, Virginia 23298-0599, United States