Placebo vs. Linoleic Acid Controlled Assessment of Treatment Efficacy in MS

Study Overview
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Brief Summary
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Several investigations have suggested that polyunsaturated fatty acids may promote therapeutic effects in MS. This pilot study will determine whether omega-6 polyunsaturated fatty acids (PUFAs),in the form of linoleic acid,can reduce disease activity and prevent disability progression in patients with relapsing MS.This study will seek to measure disease activity as seen on MRI scans in addition to measuring relapse rates.

Detailed Description
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Participants who meet inclusion criteria will start placebo treatment by taking olive oil for 2 months. This period will include screening activities including 3 monthly MRIs. Those with 2 enhancing lesions on three placebo run-in period MRIs will continue in the study and receive omega-6 PUFA (linoleic acid) for 6 months. Brain MRIs will be repeated after 4,5, and 6 months after treatment.

Official Title
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Phase II Study of Linoleic Acid in Relapsing Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: Linoleic Acid/Oleic Acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Relapsing MS treated with FDA-approved dosage of interferon-beta (Avonex,Betaseron,Rebif), glatiramer acetate for at least 6 months OR no immunotherapy for at least 3 months at least one clinical exacerbation or at least one gadolinium enhancing lesion on brain MRI in the past 12 months at least two gadolinium enhancing lesions on three brain MRIs obtained during the placebo run-in period women of childbearing potential may participate provided that they are using adequate birth control methods for the duration of the study. Women of childbearing potential must have a negative pregnancy test at baseline and be non-lactating. willing and able to provide informed consent Exclusion Criteria: corticosteroids within 1 month prior to screening treatment with other immunotherapies (other than interferon-beta, glatiramer acetate or sporadic corticosteroids) within 3 months prior to screening any significant medical condition or laboratory abnormality which may interfere with the subject's ability to participate in the study, including peptic ulcer disease, avascular necrosis and hepatic insufficiency history of hypersensitivity or intolerability to vegetable oils or their constituents unable to perform any of the required study procedures

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>placebo/active crossover | Drug: Linoleic Acid/Oleic Acid<br>* Dietary Supplement: Linoleic acid emulsion 30g bid/Oleic acid emulsion 30g bid<br>* Other names: sunflower oil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Within patient change in the sum of gadolinium-enhancing lesions on brain MRIs obtained during the treatment period compared to pre-treatment. |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annualized relapse rate |  | 9 months | 
| Changes in depression and fatigue symptoms on standardized questionnaires (Beck Depression Scale and Modified Fatigue Impact Scale). |  | 9 months | 
| Changes in T2 lesion counts/volume, change in T1 hypointense lesion counts/volume, white matter volume and gray matter volume |  | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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relapsing multiple sclerosis, polyunsaturated fatty acids, omega-6 fatty acids