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

History of Changes

Tracking Information

First Received Date ^ICMJE

March 10, 2008

Last Updated Date

September 16, 2011

Start Date ^ICMJE

March 2008

Estimated Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00638196 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Phase II Study of Linoleic Acid in Relapsing Multiple Sclerosis

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Multiple Sclerosis

Intervention ^ICMJE

Dietary Supplement: Linoleic Acid/Oleic Acid

Linoleic acid emulsion 30g bid/Oleic acid emulsion 30g bid

Other Name: sunflower oil

Study Arm (s)

Experimental: 1

placebo/active crossover

Intervention: Dietary Supplement: Linoleic Acid/Oleic Acid

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2012

Estimated Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00638196

Other Study ID Numbers ^ICMJE

22084

Has Data Monitoring Committee

Yes

Responsible Party

University of Rochester

Study Sponsor ^ICMJE

University of Rochester

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Andrew D Goodman, MD

University of Rochester

Information Provided By

University of Rochester

Verification Date

September 2011

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

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