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From the Beth Israel Deaconess Medical Center Comprehensive Epilepsy Program and Departments of Neurology (Dr. Schachter), Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA; the Hospital for Joint Diseases (Dr. Vazquez), New York, NY; Barrow Neurological Institute (Dr. Fisher), Phoenix, AZ; University of California at San Francisco (Dr. Laxer), CA; EPI-CARE Center (Dr. Montouris), Memphis, TN; Southwestern Medical Center (Dr. Combs-Cantrell), Dallas, TX; University of Alabama Epilepsy Center (Dr. Faught), Birmingham, AL; University of Texas Medical School (Dr. Willmore), Houston, TX; Medical College of Wisconsin (Dr. Morris), Milwaukee, WI; University of Washington Regional Epilepsy Center at Harborview (Dr. Ojemann), Seattle, WA; and Novartis Pharmaceuticals Corporation (Drs. Bennett, Mesenbrink, D’Souza, and Kramer), East Hanover, NJ.
Address correspondence and reprint requests to Dr. Steven C. Schachter, Department of Neurology, Beth Israel Deaconess Medical Center, KS-478, 330 Brookline Avenue, Boston, MA 02215; e-mail: Sschacht{at}bidmc.harvard.edu
OBJECTIVE: To evaluate the efficacy and safety of oxcarbazepine in a placebo-control trial.
METHODS: A multicenter, double-blind, randomized, placebo-control, two-arm parallel group, monotherapy design was used to compare oxcarbazepine administered 1,200 mg twice daily to placebo in hospitalized patients with refractory partial seizures, including simple and complex partial seizures and partial seizures evolving to secondarily generalized seizures. Patients exited the trial after completing the 10-day double-blind treatment phase or after experiencing four partial seizures, two new-onset secondarily generalized seizures, serial seizures, or status epilepticus, whichever came first.
RESULTS: Analysis of the primary efficacy variable—time to meeting one of the exit criteria—showed a statistically significant effect in favor of oxcarbazepine (p = 0.0001). The secondary efficacy variables—percentage of patients who met one of the exit criteria (p = 0.0001) and total partial seizure frequency per 9 days during the double-blind treatment (p = 0.0001)—were also statistically significant in favor of oxcarbazepine.
CONCLUSION: These results demonstrate that oxcarbazepine given as monotherapy is effective and safe for the treatment of partial seizures in this paradigm.
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