Relapsing-Remitting Multiple SclerosisPhase 2/3NCT00360906

Omega-3 Fatty Acid Treatment in Multiple Sclerosis

A Phase 2/3 study testing Triomar™ (omega-3 fatty acids) in people with Relapsing-Remitting Multiple Sclerosis, run by Haukeland University Hospital at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Relapsing-Remitting Multiple Sclerosis
What is being tested?: Triomar™ (omega-3 fatty acids)
How many people: 100 participants
Where: 1 siteNorway
Study dates: Dec 2004to Jul 2008
Phase: Phase 2/3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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.

Show all 20Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Norway1 site

Department of Neurology, Haukeland University Hospital
Bergen, N-5021

Other trials in Norway

About this study

Read the 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 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.

Conditions: Relapsing-Remitting Multiple Sclerosis
Being tested: Triomar™ (omega-3 fatty acids)
Keywords: RRMS, Omega-3, Treatment
Medical subject headings: Multiple Sclerosis, Relapsing-Remitting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Triomar™ (omega-3 fatty acids)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
MRI disease activity as measured by the number of new or enlarging T2 lesions and enhancing T1 lesions during the first six months and the whole study period of 24 months.
Changes in serum concentrations of mono-unsaturated fatty acids, saturated fatty acids, omega-3- and omega-6 fatty acids during the study.
Changes in immune responses during the first six months and the whole study period of 24 months.
The occurrence of adverse events during the first six months and the whole study period of 24 months.
The occurrence of adverse events during the first three months of interferon-beta 1a (Rebif®) treatment.
The occurrence of neutralising antibodies against interferon-beta 1a (Rebif®) during the study.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2004Jul 2008

First posted7 Aug 2006 (estimated)
Study startDec 2004
Study completionJul 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Relapsing-Remitting Multiple SclerosisStudies of the same condition, open and under way.
More trials run by Haukeland University HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 100 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00360906
Sponsor's protocol ID: NSD-10842
Other IDs: OFAMS, REK VEST, 005.04
Status last verified: Aug 2006
First submitted: 4 Aug 2006
Last updated: 7 Aug 2006
Results posted: No

Publications

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.
PubMed 10987373
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.
PubMed 34978580
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.
PubMed 29209636
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.
PubMed 22507886

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)
PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting
Recruiting
Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study
Multiple Sclerosis (MS) - Relapsing-remitting, Upper Extremity Dysfunction
Not yet recruiting
Treatment of Memory Retrieval Impairments in MS With HDtDCS to the LIFG in a Placebo Controlled Trial
Multiple Sclerosis, Relapsing-remitting Multiple Sclerosis (RRMS)
Recruiting
Monthly Monitoring of Plasma NfL in Treated Relapsing-remitting Multiple Sclerosis to Detect Persistent Infraclinical Disease Activity
Multiple Sclerosis (MS) - Relapsing-remitting
Active, not recruitingPhase 4
Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis
Multiple Sclerosis

All Relapsing-Remitting Multiple Sclerosis trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Omega-3 Fatty Acid Treatment in Multiple Sclerosis
ClinicalTrials.gov ID: NCT00360906
Acronym / sponsor ID: NSD-10842
Conditions: Relapsing-Remitting Multiple Sclerosis
Keywords: RRMS, Omega-3, Treatment
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants
Lead sponsor: Haukeland University HospitalUniversity, hospital or other
Collaborators: The Multiple Sclerosis National Competence Centre, The Norwegian Multiple sclerosis Society, Pronova BioPharma, Serono Nordic, Amersham Health
Study start: Dec 2004
Study completion: Jul 2008
First posted: 7 Aug 2006 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (20 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Triomar™ (omega-3 fatty acids)	Drug	–

Primary outcome

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.

11 secondary outcomes

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.
MRI disease activity as measured by the number of new or enlarging T2 lesions and enhancing T1 lesions during the first six months and the whole study period of 24 months.
Changes in serum concentrations of mono-unsaturated fatty acids, saturated fatty acids, omega-3- and omega-6 fatty acids during the study.
Changes in immune responses during the first six months and the whole study period of 24 months.
The occurrence of adverse events during the first six months and the whole study period of 24 months.
The occurrence of adverse events during the first three months of interferon-beta 1a (Rebif®) treatment.
The occurrence of neutralising antibodies against interferon-beta 1a (Rebif®) during the study.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2006.
Background: PubMed 10987373Nordvik 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.
Derived from this study: PubMed 34978580Lie 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.
Derived from this study: PubMed 29209636Varhaug 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.
Derived from this study: PubMed 22507886Torkildsen 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.

Related trials for Relapsing-Remitting Multiple Sclerosis

Active, not recruiting
Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)
PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting
Recruiting
Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study
Multiple Sclerosis (MS) - Relapsing-remitting, Upper Extremity Dysfunction
Not yet recruiting
Treatment of Memory Retrieval Impairments in MS With HDtDCS to the LIFG in a Placebo Controlled Trial
Multiple Sclerosis, Relapsing-remitting Multiple Sclerosis (RRMS)
Recruiting
Monthly Monitoring of Plasma NfL in Treated Relapsing-remitting Multiple Sclerosis to Detect Persistent Infraclinical Disease Activity
Multiple Sclerosis (MS) - Relapsing-remitting
Active, not recruitingPhase 4
Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis
Multiple Sclerosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kjell-Morten Myhr, MD, PhD study chair

Dep. of Neurology, Haukeland University Hospital

Antonie G. Beiske, MD principal investigator

Dep. of Neurology, Akershus University Hospital

Harald Hovdal, MD principal investigator

Dep. of Neurology, Trondheim University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Triomar™ (omega-3 fatty acids) in people with Relapsing-Remitting Multiple Sclerosis, run by Haukeland University Hospital at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MRI disease activity measured by the number of new T1-enhancing lesions during the six months of treatment.. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00360906, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2006.