The purpose of the study is to determine if lipoic acid can preserve mobility and protect the brain in progressive forms of multiple sclerosis.
This two-year study will determine if daily oral intake of lipoic acid will prove superior to placebo in reducing injury to the brain and maintaining mobility in progressive MS. Mobility will be assessed with the timed 25-foot walk test and 2-minute timed walk test as well as fall counts. Neuroprotection will be measured by the extent of brain volume loss seen on MRI.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
115
1200 mg taken by mouth daily for two years starting on day one of the study and ending on the last day of study participation.
The placebo comparator will be taken by mouth daily for two years starting on day one of the study and ending on the last day of study participation
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Colorado
Aurora, Colorado, United States
Washington DC VA Medical Center, Washington, DC
Washington D.C., District of Columbia, United States
Change in Mobility: Timed 25 Foot Walk
T25FW was transformed to walking speed by dividing 25 feet by the completion time in seconds (ft/sec). The change in walking speed across 24 months was compared between treatment groups using a mixed models analysis.
Time frame: 24 months
Change in Mobility: 2-minute Timed Walk
The score is the distance, in meters, the subject walks in 2 minutes. The change in walking distance across 24 months was compared between treatment groups using a mixed models analysis.
Time frame: 24 months
Mobility: Fall Count
Change in number of falls recorded from Baseline to year 2
Time frame: 24 months
Brain Atrophy by MRI
Change in whole brain volume from baseline to 24 months
Time frame: 24 months
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VA Portland Health Care System, Portland, OR
Portland, Oregon, United States
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, United States
University of Utah
Salt Lake City, Utah, United States
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, United States
University of Vermont
Burlington, Vermont, United States
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States
Swedish Medical Center
Seattle, Washington, United States
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