Authors
Timothée Lenglet, Lucette Lacomblez, Jean-Louis Abitbol, Albert Ludolph, Jesús S Mora, Wim Robberecht, Pamela J Shaw, Rebecca M Pruss, Valerie Cuvier, Vincent Meininger, Mitotarget Study Group, Vincent Meininger, Pr Lucette Lacomblez, François Salachas, Gaëlle Bruneteau, Pierre‐François Pradat, Timothée Lenglet, Marie Lebouteux, Vanessa Pibiri, Jean Pouget, Annie Verschueren, Emmanuelle Campana‐Salort, Sharam Attarian, Philippe Couratier, Blerta Nicolaud, Géraldine Lautrette, William Camu, Raoul Morales, Nicolas Pageot, Claude Desnuelle, Marie‐Hélène Soriani, Emilien Delmont, Alain Destee, Véronique Danel‐Brunaud, David Devos, Nadia Vandenberghe, Emmanuel Broussolle, Christophe Vial, Rubén Martires Blanco Díaz, Françoise Bouhour, Jesús S Mora Pardina, Delia Chaverri, Javier Mascías, María Hernández, Saul Marín, Teresa Salas, Yolanda Moran, Wim Robberecht, Philip Van Damme, Jelle Demeestere, Ammar Al‐Chalabi, Nigel Leigh, Carlos Guevara, Nikolay Dimitrov, Lokesh Wijesekera, Pamela Shaw, Christopher J McDermott, Muhammad Rafiq, Albert Ludolph, Johannes Dorst, Stefan Waibel, Ulriche Weiland, Corinna Hendrich, Reinhardt Dengler, Suzanne Petri, Katja Maureen Kollewe, Sonja Schmalbach, Anna‐Lena Cordes, Klaus Rath, Linda Bonzel, Seza Bolat, Thomas Meyer, André Maier, Jörn Dullinger, Peter Linke, Teresa Holm, Nadja Borisow, Stephan Zierz, Frank Hanisch
Publication date
2014/3
Journal
European journal of neurology
Volume
21
Issue
3
Pages
529-536
Description
Background and purpose
To assess the efficacy and safety of olesoxime, a molecule with neuroprotective properties, in patients with amyotrophic lateral sclerosis (ALS) treated with riluzole.
Methods
A double‐blind, randomized, placebo‐controlled, multicenter trial of 18 months’ duration was conducted in 512 subjects, with probable or definite ALS and a slow vital capacity (SVC) ≥70%, receiving 330 mg olesoxime daily or matching placebo and 50 mg riluzole twice a day in all. The primary intention‐to‐treat (ITT) outcome analysis was 18 months’ survival. Secondary outcomes were rates of deterioration of the revised ALS functional rating scale (ALSFRS‐R), focusing on the 9‐month assessment, SVC and manual muscle testing. Blood levels, safety and tolerability of olesoxime were also assessed.
Results
At 18 months, 154 of the 512 ITT patients had died (79 of 253 placebo, 75 of 259 olesoxime). Estimated …
Scholar articles
T Lenglet, L Lacomblez, JL Abitbol, A Ludolph, JS Mora… - European journal of neurology, 2014