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Sponsors and Collaborators: |
Haukeland University Hospital The Multiple Sclerosis National Competence Centre The Norwegian Multiple sclerosis Society Pronova Biocare Serono Nordic Amersham |
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Information provided by: | Haukeland University Hospital |
ClinicalTrials.gov Identifier: | NCT00360906 |
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™).
Condition | Intervention | Phase |
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Relapsing-Remitting Multiple Sclerosis |
Drug: Triomar™ (omega-3 fatty acids) |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Omega-3 Fatty Acid Treatment in Multiple Sclerosis |
Estimated Enrollment: | 100 |
Study Start Date: | December 2004 |
Estimated Study Completion Date: | July 2008 |
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 included in the study.
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.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A patient may be included if he/she;
Exclusion Criteria:
A patient has to be excluded if he/she;
Norway | |
Department of Neurology, Haukeland University Hospital | |
Bergen, Norway, N-5021 |
Study Chair: | Kjell-Morten Myhr, MD, PhD | Dep. of Neurology, Haukeland University Hospital |
Principal Investigator: | Antonie G. Beiske, MD | Dep. of Neurology, Akershus University Hospital |
Principal Investigator: | Harald Hovdal, MD | Dep. of Neurology, Trondheim University Hospital |
Principal Investigator: | Rune Midgard, MD, PhD | Dep. of Neurology, Molde Hospital |
Principal Investigator: | Ingrid K. Bjørnå, MD | Dep. of Neurology, Buskerud Hospital |
Principal Investigator: | Olaf A. Henriksen, MD | Dep. of Neurology Nordland Hospital |
Principal Investigator: | Jan Schepel, MD | Dep. of Neurology Haugesund Hospital |
Principal Investigator: | Randi Eikeland, MD | Dep. of Neurology Arendal Hospital |
Principal Investigator: | Terje Kristensen, MD | Dep. of Neurology Fredrikstad Hospital |
Principal Investigator: | Halfdan Kierulf, MD | Dep. of Neurology Rikshospitalet University Hospital |
Principal Investigator: | Frøydis Dalane, MD | Dep. of Neurology, Telemark Hospital |
Principal Investigator: | Alla Bru, MD | Dep. of Neurology, Stavanger University Hospital |
Principal Investigator: | Grethe Kleveland, MD | Dep. of Neurology, Lillehammer Hospital |
Study ID Numbers: | NSD-10842, OFAMS, REK VEST, 005.04 |
Study First Received: | August 4, 2006 |
Last Updated: | August 4, 2006 |
ClinicalTrials.gov Identifier: | NCT00360906 |
Health Authority: | Norway: Norwegian Medicines Agency |
RRMS Omega-3 Treatment |
Autoimmune Diseases Multiple Sclerosis Demyelinating Diseases Multiple sclerosis Demyelinating Autoimmune Diseases, CNS |
Demyelinating diseases Sclerosis Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases of the Nervous System |
Pathologic Processes Immune System Diseases Nervous System Diseases |