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A randomized trial on the treatment of the first epileptic seizure scientific background, rationale, study design and protocol

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Abstract

Observational studies suggest that the sooner treatment is started after the onset of seizures the better is the outcome of the disease. However, when to start antiepileptic treatment is still debated and this may explain the different behaviour of practising physicians. For these reasons, a multicenter randomized controlled trial comparing the treatment of the first seizure and the treatment of the recurrences (the two most common strategies in clinical practice) has been started in Italy. The scientific background, the study rationale and design, and the general characteristics of the study population (498 patients) are presented here.

Sommario

I risultati di studi osservazionali indicano che quanto più precoce è il trattamento delle crisi epilettiche tanto migliore è la prognosi della malattia. Comunque, è tuttora discusso quando iniziare il trattamento. Ciò tende a giustificare la variabilità degli approcci terapeutici attuati nella pratica clinica corrente. Per tali motivi, è stato intrapreso in Italia uno studio clinico controllato multicentrico volto a comparare le due modalità terapeutiche più comuni, cioè l'inizio del trattamento dopo la prima crisi epilettica ed il trattamento solo dopo una ricorrenza delle crisi. Nel presente articolo sono illustrati i principali dati bibliografici di riferimento, il razionale ed il disegno dello studio, e le caratteristiche principali della popolazione in esame (498 casi).

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Author information

Authors and Affiliations

  1. Istituto di Ricerche Biomediche Avanzate, CNR, Via Eritrea, 62-29157, Milano

    Beghi E., Musicco M., Viani F., Bordo B., Hauser W. A. & Nicolosi A.

  2. Istituto di Ricerche Farmacologiche “Mario Negri”, Via Eritrea, 62-29157, Milano

    Beghi E., Musicco M., Viani F., Bordo B., Hauser W. A. & Nicolosi A.

  3. Sezione di Neuroepidemiologia della SIN, Via Eritrea, 62-29157

    Beghi E., Musicco M., Viani F., Bordo B., Hauser W. A. & Nicolosi A.

  4. Clinica Neurologica, Ospedale S. Gerardo, Monza

    Beghi E., Musicco M., Viani F., Bordo B., Hauser W. A. & Nicolosi A.

Authors
  1. Beghi E.
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  2. Musicco M.
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  3. Viani F.
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  4. Bordo B.
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  5. Hauser W. A.
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  6. Nicolosi A.
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Additional information

Principal investigators:Musicco M., Beghi E., Bordo B., Viani F.

Advisory Board:W. Allen Hauser, Ettore Marubini, Laura Fratiglioni, Alfredo Nicolosi.

Members:G. Bogliun, Ospedale “San Gerardo”, Monza;P. Aloisi, G. Cerone, C. Porto, Ospedale “Santa Maria di Collemaggio”, L'Aquila;P. Bassi, C. Francesconi, P. Gambaro, Ospedale “Luigi Sacco”, Milano;P. Basso, Centro Regionale per l'Epilessia, Gallarate;R. Freschi, S. Meregalli, Ospedale di Legnano;E. Boati, A. Mamoli, B. Galavotti, M. Camerlingo, M.R. Rottoli, Ospedali Riuniti, Bergamo;E. Bottacchi, L. Carenini, M. Leone, L. Sironi, Ospedale Regionale, Aosta;G.L. Casara, G. Matticchio, Ospedale Policlinico, Padova;E. Covezzi, G. Tortorici, Ospedale Civile, Pordenone;E. Franzoni, V. Marchiani, Ospedale “Sant'Orsola”, Bologna;G. Giuliani, S. Polonara, S. Terziani (Clinica Neurologica),A. Quattrini, A. Ortenzi, A. Paggi (Centro per l'Epilessia), Ospedale Generale Regionale “Torrette” and Ospedale “Umberto I”, Ancona;R. Daniele, G. Mattioli, G. Saladino, Ospedzale “Monaldi”, Napoli;F. Iemolo, G. D'Asta, Ospedale Civile, Vittoria;C. Geda, G.F. Ferrari, M.A. Binetti, A. Martini, M.T. Perenchio, Ospedale Civile Ivrea;R. Lisi, Ospedale di Fidenza;C. Lona, Ospedale Regionale, Bolzano;A. Bianchi, S. Severi, L.P. Zolo, Ospedale Civile, Arezzo;V. Montano, F. Fassio, M. Novellone, Ospedale Civile, Asti;L. Vignolo, (Clinica Neurologica),L. Antonini, M.P. Pasolini (Divisione Neurofisiopatologia, Centro Regionale per l'Epilessia), Ospedale Civile, Brescia;G. Rossi, Ospedale Civile, Rovereto;S. Feller, S. Sbrascini, Ospedale Civile, Garbagnate;P.G. Zagnoni, Ospedale “Santa Croce”, Cuneo;D. Zerbi, D. Clerici, Ospedale Civile, Saronno;A. Romeo, M.P. Gulotta, Centro Regionale di Epilettologia Infantile, Milano;B. Lucci, Ospedale di Udine;E. Russo, S. Mazza, Università Cattolica, Roma;M. De Mattei, R. Cremo, Ospedale “Molinette”, Torino;S. Gentile, N. Lovera, D. Piazza, Ospedale “Giovanni Bosco”, Torino.Clinical Monitors:I. Currado, A. Solari, Istituto di Tecnologie Biomediche Avanzate, CNR, Milano,A. Ciccone, Istituto di Ricerche Farmacologiche “M. Negri”, Milano.

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Beghi, E., Musicco, M., Viani, F. et al. A randomized trial on the treatment of the first epileptic seizure scientific background, rationale, study design and protocol. Ital J Neuro Sci 14, 293–301 (1993). https://doi.org/10.1007/BF02339295

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