Placebo vs. Linoleic Acid Controlled Assessment of Treatment Efficacy in MS - Full Text View

Sponsor:	University of Rochester
Information provided by (Responsible Party):	University of Rochester
ClinicalTrials.gov Identifier:	NCT00638196

Purpose

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.

Condition	Intervention	Phase
Multiple Sclerosis	Dietary Supplement: Linoleic Acid/Oleic Acid	Phase I

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Phase II Study of Linoleic Acid in Relapsing Multiple Sclerosis

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Oleic acid

U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	20
Study Start Date:	March 2008
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 placebo/active crossover	Dietary Supplement: Linoleic Acid/Oleic Acid Linoleic acid emulsion 30g bid/Oleic acid emulsion 30g bid Other Name: sunflower oil

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 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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00638196

Locations

United States, New York
University of Rochester
Rochester, New York, United States, 14642

Sponsors and Collaborators

University of Rochester

Investigators

Principal Investigator:

Andrew D Goodman, MD

University of Rochester

More Information

No publications provided

Responsible Party:	University of Rochester
ClinicalTrials.gov Identifier:	NCT00638196 History of Changes
Other Study ID Numbers:	22084
Study First Received:	March 10, 2008
Last Updated:	September 16, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Rochester:

relapsing multiple sclerosis
polyunsaturated fatty acids
omega-6 fatty acids

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases

Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012