Felbamate in the treatment of partial-onset seizures.
Felbamate (FBM, Felbatol/Taloxa) has been the object of several trials that are innovative and unique. First, FBM is the first antiepileptic drug (AED) to have been submitted to a controlled efficacy study in patients with the Lennox-Gastaut syndrome (LGS) before being submitted for regulatory approval. Second, FBM was tested in patients discontinued from other AEDs for presurgical monitoring. Third, FBM was the first experimental AED to have been tested in controlled monotherapy trials. Overall, these studies succeeded in demonstrating that FBM is relatively safe and effective against both partial-onset seizures and the generalized seizures occurring in the LGS. The results of some of these studies could not always be expressed by using the more familiar concept of percent seizure reduction because, for ethical reasons, the efficacy variable had to be defined in terms of time to the nth seizure or in terms of escape criteria. This may make it more difficult to evaluate just how effective FBM is in comparison with other AEDs. Another reason why the efficacy of FBM cannot yet be fully assessed is that in all the studies the FBM dosage was limited to a maximum of 3,600 mg/day or 45 mg/kg/day. At this dosage, FBM produced no toxicity in the majority of patients, and its full therapeutic toxicity in the majority of patients, and its full therapeutic effect may have to be re-evaluated in the future at higher dosages.
Department of Neurology, Washington University, St. Louis, MO 63110.
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Bourgeois
D000328:Adult; D000927:Anticonvulsants / Q000009:adverse effects / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D015507:Drugs, Investigational / Q000627:therapeutic use; D004828:Epilepsies, Partial / Q000188:drug therapy*; D000078328:Felbamate; D006801:Humans; D015337:Multicenter Studies as Topic; D048448:Phenylcarbamates; D010919:Placebos; D011409:Propylene Glycols / Q000009:adverse effects / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic
D000927:Anticonvulsants; D015507:Drugs, Investigational; D048448:Phenylcarbamates; D010919:Placebos; D011409:Propylene Glycols; D000078328:Felbamate