title: A multicenter, placebo-controlled, double-blind study of efficacy of a new form of carbamazepine (Carbatrol) in refractory epileptic patients.
abstract: 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.
authors.affiliation: Department of Pediatric Neurology and Rehabilitation, Medical University of Białystok, Waszyngtona 17, PL 15-274, Białystok, Poland.
authors.forename: Wojciech
authors.initials: W
authors.lastname: Sobaniec
authors.forename: Wojciech
authors.initials: W
authors.lastname: Kułak
authors.forename: Joanna
authors.initials: J
authors.lastname: Smigielska-Kuzia
authors.forename: Leszek
authors.initials: L
authors.lastname: Boćkowski
authors.forename: Jerzy
authors.initials: J
authors.lastname: Majkowski
authors.forename: Joanna
authors.initials: J
authors.lastname: Jedrzejczak
mesh_terms: D000293:Adolescent; D000328:Adult; D002220:Carbamazepine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D002626:Chemistry, Pharmaceutical; D016009:Chi-Square Distribution; D003692:Delayed-Action Preparations / Q000009:adverse effects / Q000627:therapeutic use; D004311:Double-Blind Method; D004827:Epilepsy / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged
chemical_list: D003692:Delayed-Action Preparations; D002220:Carbamazepine