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Safety and Efficacy of Divalproex Sodium Monotherapy in Partial Epilepsy

A Double-blind, Concentration-response Design Clinical Trial

The Depakote Monotherapy for Partial Seizures Study Group*.
*See page 187 for members of the Depakote Monotherapy for Partial Seizures Study Group.
From the Department of Neurology (Dr. Beydoun), University of Michigan Medical Center, Ann Arbor, MI; Veterans Affairs Medical Center (Dr. Sackellares), Gainesville, FL; and Abbott Laboratories (Dr. Shu), Abbott Park, IL.
Supported by a grant from Abbott Laboratories, North Chicago, IL.
Received March 1, 1996. Accepted in final form June 13, 1996.
Address correspondence and reprint requests to Dr. A. Beydoun, Department of Neurology, University of Michigan Medical Center, 1500 East Medical Center Drive, University Hospital 1 B300/0036, Ann Arbor, MI 48109.

This is the first randomized, double-blind, parallel-group, multicenter trial that evaluated the efficacy of divalproex sodium monotherapy by comparing seizure frequency in 143 patients with poorly controlled partial epilepsy randomly assigned to high (80 to 150 micro g/mL; 555 to 1,040 micro mol/L) or low (25 to 50 micro g/mL; 175 to 345 micro mol/L) plasma valproate groups. There was a statistically significant reduction from baseline in the 8-week frequency of complex partial (p = 0.001) and secondarily generalized tonic-clonic seizures (p = 0.018) for patients in the high, compared with the low, plasma valproate group. Compared with baseline, there was a 30% median reduction in complex partial seizures for patients in the high group and a 19% increase for those in the low group. The median reduction for secondarily generalized tonic-clonic seizures was 70% for patients in the high group compared with a 22% increase in the low group. Adverse events that occurred significantly more frequently in the high group included tremors, thrombocytopenia, alopecia, asthenia, diarrhea, vomiting, and anorexia. This study demonstrates the efficacy of divalproex sodium as monotherapy for the treatment of partial-onset seizures and supports its role as one of the first-line antiepileptic drug treatments for patients with partial epilepsy.

NEUROLOGY 1997;48: 182-188

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