Trophos announces final patient completion of pivotal phase three efficacy study of olesoxime in Amyotrophic Lateral Sclerosis
Trophos SA announced that the last patient has now completed the major pivotal phase three efficacy study of olesoxime in amyotrophic lateral sclerosis (ALS).
Over 500 patients were enrolled in the study and the last patient completed the prescribed study protocol procedures on 15th September. Work is now ongoing to finalise the analysis of the data. Efficacy and safety top-line results are expected in the fourth quarter of 2011.
The study is part of the EU FP7 three-year MitoTarget project, comprising a pan-European consortium of leading experts in ALS and spearheaded by Trophos. The trial protocol has benefited from EMEA Scientific Advice procedure.
"We are very pleased with the speed and efficiency of the completion of the treatment of over 500 patients in this key clinical study of olesoxime in ALS. This reflects the motivation and hard work of all involved and the commitment of the patients, their carers and the teams at the clinical sites," said Jean-Louis Abitbol, chief medical officer at Trophos. "We are all looking forward with great anticipation to the results of the study, due before the end of the year.”
This phase three study is an 18-month randomized, parallel group, double-blind trial evaluating the efficacy and safety of olesoxime against a placebo in patients diagnosed with ALS between six and thirty six months before enrolment who are already treated with riluzole. Olesoxime is dosed at 330 mg oral capsules once a day and riluzole is dosed in both arms at 50 mg twice a day. The study is being undertaken in 15 centers in France, Germany, UK, Belgium and Spain.
The primary end-point of the study is the overall 18 month survival rate. Secondary end-points include the ALS Functional Rating Scale, time to assisted ventilation, vital capacity (a measure of respiratory function), Manual Muscular Testing and quality of life. Safety and tolerability is closely monitored and an independent Data Safety Monitoring Board is overseeing the trial.
The study is sponsored by Trophos and is being performed by a consortium of prominent European clinical investigators, all of whom have extensive prior experience conducting and collaborating in large multi-center clinical trials in ALS.
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