Long-Term Open-Label Efficacy, Safety, and Tolerability Study of Trileptal[reg] in Patients with Medically Intractable Partial Seizures.
Abstract number :
1.270
Submission category :
Year :
2001
Submission ID :
305
Source :
www.aesnet.org
Presentation date :
12/1/2001 12:00:00 AM
Published date :
Dec 1, 2001, 06:00 AM
Authors :
S.C. Schachter, MD, Neurology, Harvard Medical School, Boston, MA; B. Vazquez, MD, Neurology, New York University, New York City, NY; R.S. Fisher, MD, PhD, Neurology, Stanford University, Stanford, CA; A. Beydoun, MD, Neurology, University of Michigan, An
RATIONALE: Trileptal[reg] (oxcarbazepine) is approved as monotherapy and adjunctive therapy for partial seizures. Efficacy has been established by double-blind studies utilizing a variety of study designs. Application of results from controlled trials to clinical practice is limited, however, by the relatively short duration of the trials. The purpose of this study was to evaluate the long-term efficacy, safety and tolerability of Trileptal[reg] in patients who previously participated in a presurgical Trileptal[reg] study.
METHODS: Protocol 004E was an open-label, outpatient, long-term efficacy, safety, and tolerability study of Trileptal[reg] in patients who had completed the monotherapy inpatient presurgical trial (Protocol 004). Enrolled patients had partial seizures with or without secondary generalization and were titrated to their most effective dose of Trileptal[reg]. The titration rate as well as treatment with concomitant antiepileptic drugs (AEDs) was at the discretion of study investigators. Study visits occurred every 2 weeks for the first 4 visits, and every 12 weeks thereafter. Seizure frequency, safety, and tolerability were assessed during the first 52 weeks of open-label treatment.
RESULTS: Of 102 patients randomized in the presurgical study, 97 patients (age 11-62; mean 33) participated in the open-label extension study, of which 27 patients were maintained on Trileptal[reg] monotherapy. Concomitant AEDs in the remaining 70 patients included phenytoin (24%), carbamazepine (23%), lamotrigine (23%), gabapentin (20%), valproate (8%), and topiramate (1%). Five patients (5%) were seizure-free throughout the 52-week observation period. The most commonly occurring adverse events reported by patients were headache (29%), dizziness (27%), diplopia (20%), fatigue (20%), nausea (14%), vomiting (12%), dyspepsia (11%), somnolence (10%), and insomnia (10%). Diplopia and fatigue were more often seen in patients treated with combination therapy than Trileptal[reg] monotherapy. Fifty-six (58%) patients completed the first 52 weeks of treatment; among the other 41 patients, 12 prematurely discontinued because of adverse events and 22 (23%) due to insufficient seizure control.
CONCLUSIONS: In this long-term extension study in patients with medically intractable partial seizures who participated in a presurgical study of Trileptal[reg], 58% of the study participants completed 52 weeks of treatment, including 5 patients who were seizure-free. Trileptal[reg] as monotherapy and adjunctive therapy was generally well tolerated. The results of this study support the long-term use of Trileptal[reg] in patients with difficult-to-control partial seizures.
Support: Novartis Pharmaceuticals
Disclosure: Salary - Joseph D[ssquote]Souza is employed by Novartis Pharmaceuticals.; Grant - Drs. Schachter, Vazquez, Fisher, and Beydoun have received research grants from Novartis Pharmaceuticals.