Proof of efficacy trials: seizure types

For proof of efficacy studies, ideally the seizure types included should al so be the most common types of seizures so that an efficacy trial can recru it patients easily and in the shortest possible time frame, provide efficac y data that is valid for a large portion of the epilepsy population, includ e readily identifiable seizure types that are simple to count, and include seizures that occur frequently enough so that the trial can be short (3 mon ths). Partial seizures are the most common seizure type in an adult populat ion and therefore they represent the first choice for proof of efficacy stu dies, provided that data in experimental models support efficacy in this se izure type. Because there are already several antiepileptic drugs (AEDs) av ailable which are effective for primary generalized seizure types, and pati ents with refractory primary generalized seizures are not so plentiful, and including these seizures as primary types to prove efficacy would be time consuming, expensive and therefore not feasible. It is concluded that, wher eas proof of concept studies may include other seizure types, the first pro of of efficacy studies should be undertaken in patients with frequent (> 3/ month) partial seizures. (C) 2001 Elsevier Science B.V. All rights reserved .