title: Felbamate: a clinical trial for complex partial seizures.
abstract: We performed a randomized, double-blind, three-period cross-over study of felbamate (FBM, 2-phenyl-1,3-propanediol dicarbamate: Carter-Wallace 554) in patients with complex partial seizures. Patients continued carbamazepine (CBZ) throughout the study and were observed in the hospital for the entire trial period. The entry criteria required at least six seizures in a 3-week baseline period (and no more than 1 week with a single seizure) with CBZ alone. Thirty subjects were randomized. Two left the study after randomization, 1 owing to seizure exacerbation, and 1 owing to hyponatremia, which may have been related to CBZ therapy. The daily dosage of 50 mg/kg (maximum 3,000 mg) FBM per day was well tolerated by all 28 patients who completed the study. Only mild adverse experience were observed during the trial. FBM reduced CBZ level (p less than 0.0001; 95% confidence interval -28%, -20%). There was no significant difference in seizure frequency between placebo and FBM periods (one-sided p = 0.172), but when a correction was made for the lower CBZ level noted during FBM periods, the data suggested a strong antiseizure effect of FBM.
authors.affiliation: Clinical Epilepsy Section Medical Neurology Branch, NINDS, National Institutes of Health, Bethesda, Maryland 20892.
authors.forename: W H
authors.initials: WH
authors.lastname: Theodore
authors.forename: R F
authors.initials: RF
authors.lastname: Raubertas
authors.forename: R J
authors.initials: RJ
authors.lastname: Porter
authors.forename: F
authors.initials: F
authors.lastname: Nice
authors.forename: O
authors.initials: O
authors.lastname: Devinsky
authors.forename: P
authors.initials: P
authors.lastname: Reeves
authors.forename: E
authors.initials: E
authors.lastname: Bromfield
authors.forename: B
authors.initials: B
authors.lastname: Ito
authors.forename: M
authors.initials: M
authors.lastname: Balish
mesh_terms: D000328:Adult; D000927:Anticonvulsants / Q000627:therapeutic use*; D002220:Carbamazepine / Q000627:therapeutic use; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004833:Epilepsy, Temporal Lobe / Q000188:drug therapy*; D000078328:Felbamate; D005260:Female; D006760:Hospitalization; D006801:Humans; D008297:Male; D008875:Middle Aged; D048448:Phenylcarbamates; D010919:Placebos; D011409:Propylene Glycols / Q000627:therapeutic use*
chemical_list: D000927:Anticonvulsants; D048448:Phenylcarbamates; D010919:Placebos; D011409:Propylene Glycols; D002220:Carbamazepine; D000078328:Felbamate