Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Men and women ≥ 18 years old
Diagnosed with Relapsing Remitting Multiple Sclerosis. Patients must be stable defined as free from relapsing episode for at least 6 months prior to Baseline
Patients must be treated with Interferon beta for at least one year
Patients must have an Expanded Disability Status Scale (EDSS) score ≤ 5
Female patients must be post-menopausal (defined as at least 12 months post cessation of menses), surgically sterile or, if of childbearing potential, using a reliable method of contraception for at least 3 months prior to Baseline and during the study. In addition, female patients must not be lactating
Patients must be able to understand and comply with study requirements
Patients must provide a written, dated and signed informed consent prior to any study procedure

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