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

NCT ID: NCT00638196

Last Updated: 2015-08-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2012-09-30

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 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.

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.

Conditions

Multiple Sclerosis

Study Design

• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

placebo/active crossover

Group Type: EXPERIMENTAL

Linoleic Acid/Oleic Acid

Intervention Type: DRUG

Dietary Supplement: Linoleic acid emulsion 30g bid/Oleic acid emulsion 30g bid

Interventions

Linoleic Acid/Oleic Acid

Dietary Supplement: Linoleic acid emulsion 30g bid/Oleic acid emulsion 30g bid

Intervention Type: DRUG

Other Intervention Names

sunflower oil

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Andrew Goodman

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew D Goodman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of Rochester

Rochester, New York, United States

Countries

United States

Other Identifiers

22084

Identifier Type: -

Identifier Source: org_study_id