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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03161028
Other study ID # B2682-R
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date July 1, 2018
Est. completion date June 30, 2024

Study information

Verified date January 2024
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to determine if lipoic acid can preserve mobility and protect the brain in progressive forms of multiple sclerosis.


Description:

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 115
Est. completion date June 30, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Diagnosis of progressive MS as defined by the study - Able to give informed consent and to adhere to study procedures. - Expanded Disability Status Scale (EDSS) 3.0 - 6.5: ambulatory for at least 20 meters without rest and use of bilateral aids (canes, crutches, walker) or better. Exclusion Criteria: - A self-reported medical or neurological problem other than MS that is a cause of progressive or fluctuating gait dysfunction - Unable to undergo MRI - Unable to follow directions in English as standardized scales are not all validated in other languages. - Current major disease or disorder other than MS (e.g., cancer, renal disease, end-stage cardiopulmonary disease, post-traumatic stress disorder, etc.) that may interfere with study procedures. Note: Stable abnormal laboratory values of no more than Grade 1 determined to not be of clinical significance to the primary treating physician for that condition may be permitted per local site investigator discretion. - Pregnant or breast-feeding. - Insulin-dependent diabetes or diabetes not controlled on oral diabetes medications. - Scheduled (every 3 months or more frequently) IV or oral steroids in the year prior to enrolment. - IV or oral steroids in the 60 days prior to enrolment. - Use of LA in the prior 2 years exceeding the equivalent of 1200mg daily for 3 months. - Participation in the pilot LA in SPMS trial.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lipoic acid
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.
Placebo
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

Locations

Country Name City State
Canada Ottawa Hospital Research Institute Ottawa Ontario
United States University of Colorado Aurora Colorado
United States University of Alabama at Birmingham Birmingham Alabama
United States University of Vermont Burlington Vermont
United States VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX Dallas Texas
United States VA Portland Health Care System, Portland, OR Portland Oregon
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 Swedish Medical Center Seattle Washington
United States VA Puget Sound Health Care System Seattle Division, Seattle, WA Seattle Washington
United States Washington DC VA Medical Center, Washington, DC Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Safety: laboratory safety monitoring, adverse event monitoring Adverse events and safety labs from baseline to year 2 Adverse events and safety labs from baseline to year 2
Primary Mobility: Timed 25 Foot Walk Change in Timed 25 Foot Walk from baseline to year 2 Change in Timed 25 Foot Walk from baseline to year 2
Secondary Mobility: 2-minute timed walk Change in 2-minute timed walk from baseline to year 2 Change in 2-minute timed walk from baseline to year 2
Secondary Mobility: Fall count Change in number of falls recorded from baseline to year 2 Change in number of falls recorded from baseline to year 2
Secondary Brain Atrophy by MRI % change brain volume from baseline to year 2 % change brain volume from baseline to year 2
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