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



Status:Terminated
Conditions:Neurology, Multiple Sclerosis
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - 70
Updated:4/21/2016
Start Date:March 2008
End Date:September 2012

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Phase II Study of Linoleic Acid in Relapsing Multiple Sclerosis

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.

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.

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
We found this trial at
1
site
60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Rochester, NY
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