Chapter 7 Clinical Trials in Epilepsy

Abstract

Publisher Summary This chapter discusses the controlled trials of antiepileptic drugs. It summarizes double-blind randomized controlled trials (RCTs). Conventional antiepileptic drugs are phenobarbital, phenytoin, carbamazepine, and sodium valproate. On comparing phenobabital with chlorazepate, a trend to improve seizure control was found with phenobarbital, but chlorazepate had less toxicity. Phenobarbital was also compared with phenytoin, primidone, and carbamazepine in the treatment of 622 untreated or undertreated adults with simple or complex partial seizures (n = 265) or secondarily generalized seizures. Phenytoin was introduced for the treatment of epilepsy in 1938 in the United States of America and soon after World War II in Europe. To the best of knowledge, no double-blind, placebo-controlled trial was ever performed. Conversely, as its efficacy and safety have been made evident, newer drugs have been compared against phenytoin. Sodium valproate was marketed in France in 1967 and a decade later in the United Kingdom. The Food and Drug Administration (FDA) approved it in 1978 for use as sole or adjunctive therapy in the treatment of absence seizures and many years later for use in more frequent types of epilepsies. Recent antiepileptic drugs include felbamate, gabapentin, lamotrigine, and oxcarbazepine.