Fact Sheet -- Rectal Administration Of Diazepam For Acute Repetitive Seizures (RADARS) Study

Overview

Funded in part by the National Institute of Neurological Disorders and Stroke (NINDS), RADARS (Rectal Administration of Diazepam for Acute Repetitive Seizures) was designed to assess the efficacy and safety of rectal diazepam gel (DiastatR) when administered by nonmedical personnel in non-acute care settings. RADARS is the first controlled study ever undertaken to examine at-home treatment of acute repetitive seizures (ARS), a serious cluster of seizures that if untreated can cause brain injury. Rectal diazepam gel also appears to increase quality-of-life and to be cost-effective, reducing the need for emergency room care.

Study Design

• Double-blind, randomized, 10-center, parallel group, placebo-controlled study.
• 91 patients (47 children and 44 adults) with a history of ARS treated with rectal diazepam gel.
• Pediatric patients received two doses--one at onset of seizures and a second 4 hours later--and were observed for 12 hours.
• Adult patients received three doses--one at onset of seizures, the second 4 hours later, and the third 12 hours later--and were observed for 24 hours.

Key Findings

Efficacy

• Difference in seizure frequency (measured by the number of seizures per hour of observation): significantly fewer for patients treated with diazepam rectal gel than for patients treated with placebo (p<0.001).
• Rectal diazepam gel demonstrated greater protection against recurrence than placebo (p<0.001).
• Caregivers reported that treatment with diazepam produced significantly superior overall outcome than placebo as compared with previous seizure episodes (p<0.001).

Safety

• For both diazepam and placebo patients, the most frequently reported adverse event was somnolence (sleepiness).
• There were no reports of serious respiratory depression.

Benefits Of Rectal Diazepam Gel

• Effective against acute repetitive seizures which could consist of complex partial or generalized type seizures.
• Possesses minimal potential for serious adverse events.
• Easily and safely administered by caregivers.
• Drug administration can be performed in most cases despite a patient's limited ability to cooperate.