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

August 7, 2015 updated by: Andrew Goodman, University of Rochester

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
placebo/active crossover
Drug: Linoleic Acid/Oleic Acid
Dietary Supplement: Linoleic acid emulsion 30g bid/Oleic acid emulsion 30g bid
Other Names:
  • sunflower oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Annualized relapse rate
Time Frame: 9 months
9 months
Changes in depression and fatigue symptoms on standardized questionnaires (Beck Depression Scale and Modified Fatigue Impact Scale).
Time Frame: 9 months
9 months
Changes in T2 lesion counts/volume, change in T1 hypointense lesion counts/volume, white matter volume and gray matter volume
Time Frame: 9 months
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (ACTUAL)

September 1, 2012

Study Completion (ACTUAL)

September 1, 2012

Study Registration Dates

First Submitted

March 10, 2008

First Submitted That Met QC Criteria

March 17, 2008

First Posted (ESTIMATE)

March 18, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 11, 2015

Last Update Submitted That Met QC Criteria

August 7, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22084

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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