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

Multiple Sclerosis Clinical Trial

Official title:
Phase II Study of Linoleic Acid in Relapsing Multiple Sclerosis

Clinical Trial 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.

Clinical Trial 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 Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00638196
Study type Interventional
Source University of Rochester
Contact
Status Terminated
Phase Phase 1
Start date March 2008
Completion date September 2012
View Details
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