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

Primary Purpose

Multiple Sclerosis

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Linoleic Acid/Oleic Acid

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring relapsing multiple sclerosis, polyunsaturated fatty acids, omega-6 fatty acids

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

placebo/active crossover

Outcomes

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.

Secondary Outcome Measures

Annualized relapse rate

Changes in depression and fatigue symptoms on standardized questionnaires (Beck Depression Scale and Modified Fatigue Impact Scale).

Changes in T2 lesion counts/volume, change in T1 hypointense lesion counts/volume, white matter volume and gray matter volume

Full Information

NCT ID

NCT00638196

First Posted

March 10, 2008

Last Updated

August 7, 2015

Sponsor

University of Rochester

1. Study Identification

Unique Protocol Identification Number

NCT00638196

Brief Title

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

Acronym

PLACATE-MS

Official Title

Phase II Study of Linoleic Acid in Relapsing Multiple Sclerosis

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Terminated

Why Stopped

funding stopped due to slow enrollment.

Study Start Date

March 2008 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Rochester

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

Keywords

relapsing multiple sclerosis, polyunsaturated fatty acids, omega-6 fatty acids

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

Participant

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

placebo/active crossover

Intervention Type

Drug

Intervention Name(s)

Linoleic Acid/Oleic Acid

Other Intervention Name(s)

sunflower oil

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Annualized relapse rate

Time Frame

9 months

Title

Changes in depression and fatigue symptoms on standardized questionnaires (Beck Depression Scale and Modified Fatigue Impact Scale).

Time Frame

9 months

Title

Changes in T2 lesion counts/volume, change in T1 hypointense lesion counts/volume, white matter volume and gray matter volume

Time Frame

9 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrew D Goodman, MD

Organizational Affiliation

University of Rochester

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Rochester

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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