Placebo vs. Linoleic Acid Controlled Assessment of Treatment Efficacy in MS (PLACATE-MS)

This study has been terminated.
(funding stopped due to slow enrollment.)
Sponsor:
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
NCT00638196
First received: March 10, 2008
Last updated: September 16, 2011
Last verified: September 2011

March 10, 2008
September 16, 2011
March 2008
September 2012   (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
Not Provided
Not Provided
 
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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Multiple Sclerosis
Dietary Supplement: Linoleic Acid/Oleic Acid
Linoleic acid emulsion 30g bid/Oleic acid emulsion 30g bid
Other Name: sunflower oil
Experimental: 1
placebo/active crossover
Intervention: Dietary Supplement: Linoleic Acid/Oleic Acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
20
September 2012
September 2012   (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 information is only displayed when the study is recruiting subjects
United States
 
NCT00638196
22084
Yes
University of Rochester
University of Rochester
Not Provided
Principal Investigator: Andrew D Goodman, MD University of Rochester
University of Rochester
September 2011

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