Efficacy and Safety of Diazepam in the Management of Refractory Epilepsy in Selected Patients Who Require Intermittent Medical Intervention for Acute Repetitive Seizures.

Pfizer

Status and phase: Completed; Phase 3

Conditions: Epilepsy, Generalized; Seizures; Epilepsy; Epilepsy, Complex Partial; Epilepsies, Partial

Treatments: Drug: Placebo; Drug: Vanquix Auto-Injector (Diazepam Injection)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00319501

K826-05-3001

B4511001 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 234 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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234 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS).

Treatment:

Drug: Placebo

Diazepam

Experimental group

Description:

During the Double-blind Period, participants received a single, age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, as a deep intramuscular injection in the mid to outer thigh. Additional doses were permissible during the Open-label Period. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.

Treatment:

Drug: Vanquix Auto-Injector (Diazepam Injection)