Omega-3 Fatty Acid Treatment in Multiple Sclerosis

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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™).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Haukeland University Hospital
• Collaborators: Amersham Health; Pronova BioPharma; Serono Nordic; The Multiple Sclerosis National Competence Centre; The Norwegian Multiple sclerosis Society

Criteria

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.