Efficacy and Safety of Diazepam in the Management of Refractory Epilepsy in Selected Patients Who Require Intermittent Medical Intervention for Acute Repetitive Seizures.
Condition: Seizures; Epilepsies, Partial; Epilepsy, Complex Partial; Epilepsy, Generalized; Epilepsy
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial; Epilepsy, Complex Partial; Epilepsy, Generalized
Intervention: Placebo; Vanquix Auto-Injector (Diazepam Injection)
Intervention description: Intramuscular autoinjector; administered at onset of an episode; Intramuscular autoinjector: 5, 10, 15, or 20 mg (based on participant's age and weight); administered at the onset of an episode
Intervention MeSH terms: Diazepam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 234.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No
Keywords: Acute Repetitive Seizures; ARS; Diazepam; Cluster Seizures

Summary:

      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.
    

Eligibility criteria:

        Key Inclusion Criteria

        For Patient:

          -  Older than 2 years of age and between 6 and 136 kg body weight

          -  Recipient of clinical diagnosis of epilepsy, taking a stable antiepileptic drug
             regimen for at least 2 weeks, and requiring 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 or lactating and is practicing an acceptable method of birth control.

        For Caregiver:

          -  Age of 18 years or older and has demonstrated responsibility as a caregiver through
             training to:

               -  Recognize an episode of repetitive seizures for which the injection was intended,

               -  Administer study drug

               -  Count and record seizures and respiratory rate in the patient diary,

               -  Monitor the patient and record observations in the patient diary for 12 hours
                  following study drug treatment

               -  Recognize the need for immediate medical attention.

        Key Exclusion Criteria

        For Patient:

          -  Petit mal status or petit mal variant status

          -  History of ARS consistently progressing to status epilepticus

          -  History of failure to respond to benzodiazepine treatment

          -  Hypersensitivity to diazepam

          -  Acute narrow angle glaucoma

          -  Alcohol and/or other substance abuse

          -  Has taken another investigational drug in previous 30 days

          -  Acute or progressive neurologic or severe psychiatric disease or severe mental
             abnormality.