Placebo vs. Linoleic Acid Controlled Assessment of Treatment Efficacy in MS
Stopped early · Phase 1
Conditions studied: Multiple Sclerosis
In brief
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.
Key facts
- Study ID
- NCT00638196
- Run by
- University of Rochester
- People needed
- 9
- Starts
- 2008-03-01
- Expected to finish
- 2012-09-01
- Last updated by the study team
- 2015-08-11
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Rochester — Rochester, New York, United States
Full record on ClinicalTrials.gov
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