Status:
TERMINATED
Placebo vs. Linoleic Acid Controlled Assessment of Treatment Efficacy in MS
Lead Sponsor:
University of Rochester
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
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 l...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00638196
Start Date
March 1 2008
End Date
September 1 2012
Last Update
August 11 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Rochester
Rochester, New York, United States, 14642