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NEUROLOGY 1998;51:1274-1282
© 1998 American Academy of Neurology

Treating repetitive seizures with a rectal diazepam formulation

A randomized study

J. J. Cereghino, MD, W. G. Mitchell, MD, J. Murphy, MD, R. L. Kriel, MD, W. E. Rosenfeld, MD, E. Trevathan, MD and The North American Diastat Study Group*

From the Oregon Health Sciences University (Dr. Cereghino), Portland, OR; the Children's Hospital of Los Angeles (Dr. Mitchell), CA; the Children's Mercy Hospital (Dr. Murphy), Kansas City, MO; Hennepin County Medical Center (Dr. Kriel), Minneapolis, MN; the Comprehensive Epilepsy Care Center for Children and Adults (Dr. Rosenfeld), St. Louis, MO; and the University of Kentucky School of Medicine (Dr. Trevathan), Lexington, KY.

Address correspondence and reprint requests to Dr Cereghino, Oregon Health Sciences University, 3181 SW Sam Jackson Park Road, CDW3, Portland, OR 97201-3098.

Objective: To evaluate the effectiveness and safety of a single-dose treatment for acute repetitive seizure (ARS) episodes (e.g., clusters) administered in a nonmedical setting by caregivers.

Background: Patients with epilepsy may experience ARS episodes despite optimal anticonvulsant treatment. Such episodes require rapid treatment as medical emergencies. Typically, the patient is treated in an emergency medical setting with IV medication by trained medical personnel.

Methods: The authors undertook a multicenter, randomized, parallel, double-blind study of a single administration of Diastat (diazepam rectal gel) for treating episodes of ARS. ARS episodes and treatment criteria were defined for each patient at the start of the study. Caregivers were taught to determine ARS episode onset, administer a predetermined dose of study medication, monitor outcome, count respirations, and record seizures and adverse events.

Results: A total of 29 centers enrolled 158 patients, of whom 114 patients had a treated ARS episode (Diastat, n = 56; placebo, n = 58). Diastat treatment reduced median seizure frequency (p = 0.029). More Diastat patients were seizure free post-treatment (Diastat, 55%; placebo, 34%; p = 0.031). Kaplan-Meier analysis of the time to the next seizure favored Diastat treatment (p < 0.007). The most common adverse event was somnolence.

Conclusion: Administration of a single rectal dose of Diastat was significantly more effective than placebo in reducing the number of seizures following an episode of ARS. Caregivers could administer treatment safely and effectively in a nonmedical setting.

*The investigators and institutions of the North American Diastat Study Group are listed in the Appendix on page 1281.

Supported by a grant from Athena Neurosciences, Inc.

Received April 25, 1998. Accepted in final form July 23, 1998.




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