A multicenter, placebo-controlled, double-blind study of efficacy of a new form of carbamazepine (Carbatrol) in refractory epileptic patients.

Author(s): Sobaniec W, Kulak W, Smigielska-Kuzia J, Bockowski L, Majkowski J, Jedrzejczak J

Affiliation(s): Department of Pediatric Neurology and Rehabilitation, Medical University of Bialystok, Waszyngtona 17, PL 15-274, Bialystok, Poland.

Publication date & source: 2004-03, Pol J Pharmacol., 56(2):195-201.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

Carbatrol (CBR) is a new multiple-unit, sustained-release dosage form of carbamazepine (CBZ) developed by Pharmavene. We present a multicenter, outpatient, randomized, double-blind parallel group study (No PI 101) carried out in two centers in Poland. CBR was evaluated in 47 patients with uncontrolled partial onset seizures. During the 28-day baseline period, patients were required to have at least two seizures and to take CBZ at a therapeutic level, a second antiepileptic drug was allowed but not valproic acid (VPA ). Patients were randomized to VPA or to CBR (dosages 800, 1200, 1600 mg/day). Criteria for escape relative to baseline were: two-fold increase in monthly seizure frequency, two-fold increase in 2-day seizure frequency, two-fold increase in weekly seizure frequency, single generalized tonic-clonic seizure (GTCs) if none occurred during baseline or prolongation of GTCs. The primary efficacy variable was the number of patients escaping in each treatment group. Nineteen patients on VPAand 7 on CBR met escape criteria. CBR adverse experiences were all mild or moderate in severity. CBR therapy was effective in the treatment of partial complex seizures with or without generalization.