Safety Study of Olesoxime in Patients With Stable Relapsing Remitting Multiple Sclerosis Treated With Interferon Beta.

Exclusion Criteria

• •Any relapse of multiple sclerosis within the past 6 months prior to Screening Visit/Visit -1
• •Any change in Interferon treatment within the past year prior to Screening Visit (Visit -1)
• •Expected use of another disease modifying therapy from Screening Visit/Visit -1 to Visit 3/Final Visit
• •Patients unable to undergo MRI scan
• •Current or expected use of a medication that could interfere with olesoxime pharmacology (e.g. tamoxifen)
• •Current or expected use of lipid lowering agents (ezetimibe, bile salt chelators, fibrates, phytosterols) other than statins
• •Known hypersensitivity to olesoxime or any of its components
• •History of alcohol or drug abuse within the last 6 months, or addiction within the last 2 years prior to Baseline Visit
• •Positive urinary pregnancy test at Baseline Visit
• •History of hepatitis B/C or HIV positive serology
• •Hepatic impairment (aspartate aminotransferase (AST) and alanine aminotransferase (ALT)\> 3 × ULN) at Baseline Visit
• •History of renal impairment defined by a serum creatinine value \> 176 μmol/L (2.0 mg/dL) at Baseline Visit
• •Abnormal and clinically significant ECG at Screening Visit/Visit -1 as assessed by a cardiologist
• •Current or expected use of oral or intramuscular corticosteroids within 3 months prior to the Screening Visit. Only stable dose regimens of inhaled and topical corticosteroids are allowed during the study
• •History of any clinically relevant gastrointestinal (GI), respiratory, psychiatric, neurological, kidney, liver, cardiac diseases, bleeding disorder, other disease/condition or abnormal physical finding which may interfere with the study objectives or put the patient's safety at risk, as judged by the Investigator
• •Patients with an active chronic disease (or stable but treated with immune therapy) of the immune system other than Multiple Sclerosis (MS)
• •History of malignancy of any organ, treated or non-treated within the past 5 years
• •Current participation or participation within 30 days prior to study entry, in another investigational drug or device study, or previous enrolment in the present study
• •Any direct involvement with the study conduct at site or any family link with study site staff
• •Pregnant, parturient or lactating women, as per Public Health Code (CSP)(Article L-1121-5)
• •Persons deprived of their liberty by a judicial or administrative decision, and those admitted to a health or social facility, as per CSP (Article L-1121-6)
• •Persons covered by a measure of legal protection or unable to provide a written, dated and signed informed consent, as per CSP(Article L-1121-8)
• •Patient without Social Security Insurance