Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
100 participants
INTERVENTIONAL
2004-12-31
2008-07-31
Brief Summary
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Detailed Description
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Eligible patients will be randomised for daily treatment with either oral omega-3 fatty acid (Triomar™) or placebo. After six months all patients will in addition receive interferon-beta 1a (Rebif™) 44 mcg subcutaneous three times per week for another 18 months.
The patients will undergo monthly contrast enhanced MRI for the first nine months and thereafter at months 12 and 24. They will also be examined by clinical and laboratory tests at six months intervals in addition to month 9 (3 months after start of IFNB treatment). Fatigue and QoL registration will be performed at baseline and at months 6, 12 and 24. Tests for circulating neutralising antibodies against interferon-beta will be performed during the study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Triomar™ (omega-3 fatty acids)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
55 Years
ALL
No
Sponsors
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The Multiple Sclerosis National Competence Centre
UNKNOWN
The Norwegian Multiple sclerosis Society
UNKNOWN
Pronova BioPharma
INDUSTRY
Serono Nordic
UNKNOWN
Amersham Health
INDUSTRY
Haukeland University Hospital
OTHER
Principal Investigators
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Kjell-Morten Myhr, MD, PhD
Role: STUDY_CHAIR
Dep. of Neurology, Haukeland University Hospital
Antonie G. Beiske, MD
Role: PRINCIPAL_INVESTIGATOR
Dep. of Neurology, Akershus University Hospital
Harald Hovdal, MD
Role: PRINCIPAL_INVESTIGATOR
Dep. of Neurology, Trondheim University Hospital
Rune Midgard, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Dep. of Neurology, Molde Hospital
Ingrid K. Bjørnå, MD
Role: PRINCIPAL_INVESTIGATOR
Dep. of Neurology, Buskerud Hospital
Olaf A. Henriksen, MD
Role: PRINCIPAL_INVESTIGATOR
Dep. of Neurology Nordland Hospital
Jan Schepel, MD
Role: PRINCIPAL_INVESTIGATOR
Dep. of Neurology Haugesund Hospital
Randi Eikeland, MD
Role: PRINCIPAL_INVESTIGATOR
Dep. of Neurology Arendal Hospital
Terje Kristensen, MD
Role: PRINCIPAL_INVESTIGATOR
Dep. of Neurology Fredrikstad Hospital
Halfdan Kierulf, MD
Role: PRINCIPAL_INVESTIGATOR
Dep. of Neurology Rikshospitalet University Hospital
Frøydis Dalane, MD
Role: PRINCIPAL_INVESTIGATOR
Dep. of Neurology, Telemark Hospital
Alla Bru, MD
Role: PRINCIPAL_INVESTIGATOR
Dep. of Neurology, Stavanger University Hospital
Grethe Kleveland, MD
Role: PRINCIPAL_INVESTIGATOR
Dep. of Neurology, Lillehammer Hospital
Locations
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Department of Neurology, Haukeland University Hospital
Bergen, , Norway
Countries
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References
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Nordvik I, Myhr KM, Nyland H, Bjerve KS. Effect of dietary advice and n-3 supplementation in newly diagnosed MS patients. Acta Neurol Scand. 2000 Sep;102(3):143-9. doi: 10.1034/j.1600-0404.2000.102003143.x.
Lie IA, Kerklingh E, Wesnes K, van Nederpelt DR, Brouwer I, Torkildsen O, Myhr KM, Barkhof F, Bo L, Vrenken H. The effect of gadolinium-based contrast-agents on automated brain atrophy measurements by FreeSurfer in patients with multiple sclerosis. Eur Radiol. 2022 May;32(5):3576-3587. doi: 10.1007/s00330-021-08405-8. Epub 2022 Jan 3.
Varhaug KN, Barro C, Bjornevik K, Myhr KM, Torkildsen O, Wergeland S, Bindoff LA, Kuhle J, Vedeler C. Neurofilament light chain predicts disease activity in relapsing-remitting MS. Neurol Neuroimmunol Neuroinflamm. 2017 Nov 28;5(1):e422. doi: 10.1212/NXI.0000000000000422. eCollection 2018 Jan.
Torkildsen O, Wergeland S, Bakke S, Beiske AG, Bjerve KS, Hovdal H, Midgard R, Lilleas F, Pedersen T, Bjornara B, Dalene F, Kleveland G, Schepel J, Olsen IC, Myhr KM. omega-3 fatty acid treatment in multiple sclerosis (OFAMS Study): a randomized, double-blind, placebo-controlled trial. Arch Neurol. 2012 Aug;69(8):1044-51. doi: 10.1001/archneurol.2012.283.
Other Identifiers
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OFAMS, REK VEST, 005.04
Identifier Type: -
Identifier Source: secondary_id
NSD-10842
Identifier Type: -
Identifier Source: org_study_id