Omega-3 Fatty Acid Treatment in Multiple Sclerosis

NCT00360906 | Completed Phase 2

• 2 other identifiers: NSD-10842OFAMS, REK VEST, 005.04
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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, 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™).

Conditions

Relapsing-Remitting Multiple Sclerosis

Keywords

RRMS; Omega-3; Treatment

Outcome Measures

Primary Outcomes (2)

• MRI disease activity measured by the number of new T1-enhancing lesions during the six months of treatment.

• MRI disease activity measured by the number of new T1-hypo-intensive lesions (black holes) after 24 months of treatment.

Secondary Outcomes (11)

• MRI disease activity measured by the number of new T1-enhancing lesions during the first 9 months and the whole study period of 24 months.

• Brain atrophy measured by total MRI brain volume at month 6 and month 24

• The number of relapses during the first six months and the whole study period of 24 months.

• The increase in disability as measured by Expanded Disability Status Scale (EDSS) during the first six months and the whole study period of 24 months.

• Changes in the Multiple Sclerosis Functional Composite (MSFC) score during the first six months and the whole study period of 24 months.

Interventions

Triomar™ (omega-3 fatty acids) DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• 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.

You may not qualify if:

• A patient has to be excluded if he/she;
• Has an active RRMS disease that would strongly be recommended for standard immunomodulatory treatment by the treating neurologist.
• Has received treatment with lymphoid irradiation, mitoxantrone, cyclophosphamide or long-term glucocorticoids.
• 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.

Sponsors & Collaborators

• Haukeland University Hospital: lead
• The Multiple Sclerosis National Competence Centre: collaborator
• The Norwegian Multiple sclerosis Society: collaborator
• Pronova BioPharma: collaborator
• Serono Nordic: collaborator
• Amersham Health: collaborator

Study Sites (1)

Department of Neurology, Haukeland University Hospital

Bergen, N-5021, Norway

Location

Related Publications (4)

• 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.

  PMID: 10987373 BACKGROUND

• 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.

  PMID: 34978580 DERIVED

• 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.

  PMID: 29209636 DERIVED

• 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.

  PMID: 22507886 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Kjell-Morten Myhr, MD, PhD

  Dep. of Neurology, Haukeland University Hospital

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 4, 2006
• First Posted: August 7, 2006
• Study Start: December 1, 2004
• Study Completion: July 1, 2008
• Last Updated: August 7, 2006

Record last verified: 2006-08

Locations

NO (1)