Placebo vs. Linoleic Acid Controlled Assessment of Treatment Efficacy
Phase II Study of Linoleic Acid in Relapsing Multiple Sclerosis
What it found
The trial ended early for another reason (see below).
Reason given: funding stopped due to slow enrollment.
This trial finished 14 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Linoleic acid
What it measured
Main measures
Within patient change in the sum of gadolinium-enhancing lesions on brain MRIs obtained during the treatment period compared to pre-treatment.
9 months
MRI lesions
Other measures (3)
Annualized relapse rate
9 months
RelapsesChanges in depression and fatigue symptoms on standardized questionnaires (Beck Depression Scale and Modified Fatigue Impact Scale).
9 months
FatigueMood and sleepChanges in T2 lesion counts/volume, change in T1 hypointense lesion counts/volume, white matter volume and gray matter volume
9 months
MRI lesionsBrain volume loss
Who could take part
Relapsing MS · 18 to 70
Show the full criteria
Inclusion criteria
1. Relapsing MS 2. 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 3. at least one clinical exacerbation or at least one gadolinium enhancing lesion on brain MRI in the past 12 months 4. at least two gadolinium enhancing lesions on three brain MRIs obtained during the placebo run-in period 5. 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. 6. willing and able to provide informed consent
Exclusion criteria
1. corticosteroids within 1 month prior to screening 2. treatment with other immunotherapies (other than interferon-beta, glatiramer acetate or sporadic corticosteroids) within 3 months prior to screening 3. 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 4. history of hypersensitivity or intolerability to vegetable oils or their constituents 5. unable to perform any of the required study procedures
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Mar 2008
Main results due
Sept 2012
Finished
Sept 2012