NCT00638196

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1 multiple-sclerosis

Timeline
Completed

Started Mar 2008

Longer than P75 for phase_1 multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 18, 2008

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

August 11, 2015

Status Verified

August 1, 2015

Enrollment Period

4.5 years

First QC Date

March 10, 2008

Last Update Submit

August 7, 2015

Conditions

Multiple Sclerosis

Keywords

relapsing multiple sclerosispolyunsaturated fatty acidsomega-6 fatty acids

Outcome Measures

Primary Outcomes (1)

  • Within patient change in the sum of gadolinium-enhancing lesions on brain MRIs obtained during the treatment period compared to pre-treatment.

    9 months

Secondary Outcomes (3)

  • Annualized relapse rate

    9 months

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

    9 months

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

    9 months

Study Arms (1)

1

EXPERIMENTAL

placebo/active crossover

Drug: Linoleic Acid/Oleic Acid

Interventions

Linoleic Acid/Oleic AcidDRUG

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

Also known as: sunflower oil
1

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Sunflower Oil

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Plant OilsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Andrew D Goodman, MD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 10, 2008

First Posted

March 18, 2008

Study Start

March 1, 2008

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

August 11, 2015

Record last verified: 2015-08

Locations

US(1)