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Placebo vs. Linoleic Acid Controlled Assessment of Treatment Efficacy in MS (PLACATE-MS)
This study is not yet open for participant recruitment.
Study NCT00638196   Information provided by University of Rochester
First Received: March 10, 2008   Last Updated: March 17, 2008   History of Changes

March 10, 2008
March 17, 2008
March 2008
September 2009   (final data collection date for primary outcome measure)
Within patient change in the sum of gadolinium-enhancing lesions on brain MRIs obtained during the treatment period compared to pre-treatment. [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00638196 on ClinicalTrials.gov Archive Site
  • Annualized relapse rate [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Changes in depression and fatigue symptoms on standardized questionnaires (Beck Depression Scale and Modified Fatigue Impact Scale). [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Changes in T2 lesion counts/volume, change in T1 hypointense lesion counts/volume, white matter volume and gray matter volume [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Same as current
 
Placebo vs. Linoleic Acid Controlled Assessment of Treatment Efficacy in MS
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.

Phase I
Interventional
Treatment, Single Blind (Subject), Uncontrolled, Crossover Assignment, Safety/Efficacy Study
Multiple Sclerosis
Dietary Supplement: Linoleic Acid/Oleic Acid
Experimental: placebo/active crossover
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Not yet recruiting
20
September 2009
September 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: Janet Vaughan, RNP 585-273-2445 janet_vaughan@urmc.rochester.edu
United States
 
NCT00638196
Steven R. Schwid, University of Rochester
22084
University of Rochester
 
Principal Investigator: Steven Schwid, MD University of Rochester
University of Rochester
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP