An Open Label safety Extension study of olesoxime (TRO19622) in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole. - OLE safety study of TRO19622 for ALS patients treated with riluzole

• Conditions: Disease under investigation : Amyotrophic lateral Sclerosis; MedDRA version: 14.0Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem Organ Class: 10029205 - Nervous system disorders

• Registration Number: EUCTR2010-021179-10-GB
• Lead Sponsor: TROPHOS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-31
• Last Update Posted: 3 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

Patients must have completed the 18-month safety and efficacy study of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole (Protocol TRO19622 CL E Q 1015-1). • Both the investigator and the patient will decide based on previous good tolerance and other clinical grounds whether or not to participate to the open-label extension. • If patients were on anti-vitamin K during the double-blind period, when entering the open-label extension, coagulation tests should be monitored in exactly the same conditions as if a new anticoagulant treatment was initiated and the dose of anti-vitamin K should be adjusted accordingly(see secti on 8.3.11). • Patients enrolling from this prior safety and efficacy study must: – If female of childbearing age of potential, continue to use adequate birth control methods and have a negative serum pregnancy test at the preceding double-blind protocol termination visit. Male and female partners must agree to use an effective method of birth control during their participation in the trial and for at least 15 days after the last IMP dose. Both partners must use reliable methods of contraception with 2 independent methods. The following measures are acceptable: Hormone contraceptives (e.g. oral contraceptives or comparable methods), intrauterine device, condoms with spermicidal coating or in combination with spermicidal creams, total abstinence or sterilisation performed in the past. – Be able to follow the investigator’s instructions and be able to comply with the visit schedule and visit requirements; and – Sign a written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Patients may not participate to this study if they have an ongoing, unresolved, clinically significant medical problem (including patients having serious adverse events or non-serious, but medically significant adverse events during the preceding safety and efficacy study that was assessed to be related to the study medication by the investigator)that is on the judgment of the investigator would make it unsafe for the patient to participate in the trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified