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Titolo:
Proof of efficacy trials: seizure types
Autore:
Ben-Menachem, E;
Indirizzi:
Sahlgrens Univ Hosp, Dept Clin Neurosci, S-41345 Gothenburg, Sweden Sahlgrens Univ Hosp Gothenburg Sweden S-41345 S-41345 Gothenburg, Sweden
Titolo Testata:
EPILEPSY RESEARCH
fascicolo: 1-3, volume: 45, anno: 2001,
pagine: 31 - 34
SICI:
0920-1211(200105)45:1-3<31:POETST>2.0.ZU;2-5
Fonte:
ISI
Lingua:
ENG
Soggetto:
TONIC CLONIC SEIZURES; ANTIEPILEPTIC DRUGS; EPILEPSY; CARBAMAZEPINE;
Keywords:
proof of efficacy trials; seizure types; partial seizures; antiepileptic drugs;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
6
Recensione:
Indirizzi per estratti:
Indirizzo: Ben-Menachem, E Sahlgrens Univ Hosp, Dept Clin Neurosci, S-41345 Gothenburg, Sweden Sahlgrens Univ Hosp Gothenburg Sweden S-41345 rg, Sweden
Citazione:
E. Ben-Menachem, "Proof of efficacy trials: seizure types", EPILEPSY R, 45(1-3), 2001, pp. 31-34

Abstract

For proof of efficacy studies, ideally the seizure types included should also be the most common types of seizures so that an efficacy trial can recruit patients easily and in the shortest possible time frame, provide efficacy data that is valid for a large portion of the epilepsy population, include readily identifiable seizure types that are simple to count, and includeseizures that occur frequently enough so that the trial can be short (3 months). Partial seizures are the most common seizure type in an adult population and therefore they represent the first choice for proof of efficacy studies, provided that data in experimental models support efficacy in this seizure type. Because there are already several antiepileptic drugs (AEDs) available which are effective for primary generalized seizure types, and patients with refractory primary generalized seizures are not so plentiful, and including these seizures as primary types to prove efficacy would be timeconsuming, expensive and therefore not feasible. It is concluded that, whereas proof of concept studies may include other seizure types, the first proof of efficacy studies should be undertaken in patients with frequent (> 3/month) partial seizures. (C) 2001 Elsevier Science B.V. All rights reserved.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 02/04/20 alle ore 12:52:46