Status:
COMPLETED
Omega-3 Fatty Acid Treatment in Multiple Sclerosis
Lead Sponsor:
Haukeland University Hospital
Collaborating Sponsors:
The Multiple Sclerosis National Competence Centre
The Norwegian Multiple sclerosis Society
Conditions:
Relapsing-Remitting Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
PHASE3
Brief 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...
Detailed Description
Patients with relapsing-remitting multiple sclerosis with evidence of disease activity defined as at least one relapse or at least one new MRI lesion during the year prior to inclusion will be include...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
End Date :
July 1 2008
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00360906
Start Date
December 1 2004
End Date
July 1 2008
Last Update
August 7 2006
Active Locations (1)
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1
Department of Neurology, Haukeland University Hospital
Bergen, Norway, N-5021