Omega-3 Fatty Acid Treatment in Multiple Sclerosis

Treatment tested

• Omega-3 fatty acids

Other measures (11)

Inclusion Criteria: A patient may be included if he/she; * Is aged between 18 and 55 years (both included). * Has multiple sclerosis according to the McDonald criteria (McDonald 2001) * Has a stable disease during the last month period prior to inclusion, and a disability equivalent to EDSS of 5.5 or less (Kurtzke 1983). * Has shown disease activity defined as at least one relapse or at least one new MRI lesion (T1 enhancing or T2 lesion - ref. McDonald criteria) during the year prior to inclusion. * Is prepared to and considered able to follow the protocol and to attend the planned visits during the whole study period. * Is using adequate contraceptive methods and has negative pregnancy test results (female of childbearing potential must). * Has given written informed consent. Exclusion Criteria: A patient has to be excluded if he/she; * Has received continuous for more than one-week treatment with unsaturated fatty acids (omega-3) within 3 months prior to inclusion in the study. * Has an active RRMS disease that would strongly be recommended for standard immunomodulatory treatment by the treating neurologist. * Has received treatment with interferon-beta or glatiramer acetate within 6 months prior to inclusion in the study. * Has received treatment with lymphoid irradiation, mitoxantrone, cyclophosphamide or long-term glucocorticoids. * Has received treatment with azathioprine, cyclosporine or other immunosuppressive agents within the year prior to inclusion in the study. * Has received treatment with glucocorticoids or ACTH within two month prior to inclusion in the study. * Has experienced a relapse within one month prior to the inclusion in the study. * Has converted to secondary progressive MS. * Has suffered from major depression or any other psychiatric disorder that would preclude safe participation in the protocol. * Has diabetes mellitus. * Has alcohol or drug abuse. * Has cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (NYHA III or IV), or malignant hypertension. * Has renal insufficiency. * Has ASAT or ALAT > 2,5 x normal upper limit. * Has leukopenia \< 2500 leukocytes per µl or thrombocytopenia \<100 000 thrombocytes per µl. * Has any systemic disease, which can influence his/her safety and compliance, or the evaluation of the disability. * Has thromboembolic disease that needs anticoagulative treatment. * Have formerly shown severe reactions against study drug, interferon-beta or gadolinium (MRI contrast). * Is breastfeeding or is pregnant.

Based on previous clinical studies indicating beneficial treatment effects of omega-3 fatty acids in multiple sclerosis, and the increasing evidence of anti-inflammatory effects of omega-3 fatty acids, this study aims to evaluate treatment effects of concentrated omega-3 fatty acids (Triomar™) in MS, both as monotherapy and in combination with standard immunomodulatory therapy defined as interferon-beta 1a (Rebif™).