The purpose of the assay is to assess the safety of TRO19622 330 mg QD as add-on therapy to riluzole 50 mg bid in the treatment of patients suffering from ALS, after completion of the preceding clinical trial (TRO19622 CL E Q 1015-1) in an open label extension.
Entry of a patient into this safety study is intended to occur immediately after the patient has finished participating in the preceding efficacy study (Protocol TRO19622 CL E Q 1015-1). The Investigator will explain to the patients the nature of this open-label safety study, its procedures, requirements and restrictions so as to obtain their written informed consent. Each patient will be treated with olesoxime (TRO19622) until the results of the double-blind trial become available with a maximum of 15 months. Follow-up visits will take place every 3 months (+/- 2 weeks). Safety assessments will be performed at all visits (every 3 months).
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
271
2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzol 50mg bid
University Hospital Gasthuisberg - Dept Neurology - Herestraat 49
Leuven, Belgium
The primary outcome measure will be the safety assessment.
safety criteria will be: * Occurrence of AEs, * Physical examination, * Laboratory tests, * Vital signs and ECG,
Time frame: Safety assessment will be calculated from the date of enrollment for a maximum of 15 months.
Secondary Outcome Measures
Secondary Outcome Measures will be: * Survival time * Total score of the 48-point ALS Functional Rating Scale Revised * Slow Vital capacity (SVC) as a percentage of predicted SVC only if the SVC is performed by the site in a routine-way during standard ALS visit. This test will not be performed for the sole purpose of the study
Time frame: Every 3 month, from the date of enrollment for a maximum of 15 months.
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Groupe Hospitalier PITIE-SALPETRIERE - Fédération des Maladies du Système Nerveux
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Charité Universitätsmedizin Berlin, Campus Virchow-Klinikum, Neurologische Poliklinik Ambulanz für ALS und andere Motoeneuronenerkrankungen
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Universitätsklinik und Poliklinik für Neurologie - Martin-Luther-Universität Halle-Wittenberg
Halle, Germany
...and 5 more locations