Lipoic Acid for Progressive Multiple Sclerosis (MS)

Phase 2

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: Placebo; Drug: Lipoic acid

• Registration Number: NCT03161028
• Lead Sponsor: VA Office of Research and Development

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-05-18
• Study First Submitted QC: 2017-05-18
• Study First Posted: 2017-05-19
• Study Start: 2018-08-17
• Primary Completion: 2023-12-31
• Study Completion: 2024-06-30
• Results First Submitted: 2024-12-30
• Status Verified: 2025-02
• Results First Submitted QC: 2025-02-11
• Last Update Submitted: 2025-02-11
• Results First Posted: 2025-03-03
• Last Update Posted: 2025-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2: Placebo	Placebo	59 subjects receive placebo daily
Arm 1: Lipoic Acid	Lipoic acid	59 subjects receive oral lipoic acid 1200mg daily

Primary Outcome Measures

Name	Time	Method
Change in Mobility: Timed 25 Foot Walk	24 months	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.

Secondary Outcome Measures

Name	Time	Method
Change in Mobility: 2-minute Timed Walk	24 months	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.
Mobility: Fall Count	24 months	Change in number of falls recorded from Baseline to year 2
Brain Atrophy by MRI	24 months	Change in whole brain volume from baseline to 24 months

Trial Locations

Locations (11)

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, United States

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX; 🇺🇸 Dallas, Texas, United States

University of Vermont; 🇺🇸 Burlington, Vermont, United States

Ottawa Hospital Research Institute; 🇨🇦 Ottawa, Ontario, Canada

Swedish Medical Center; 🇺🇸 Seattle, Washington, United States

University of Colorado; 🇺🇸 Aurora, Colorado, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

VA Salt Lake City Health Care System, Salt Lake City, UT; 🇺🇸 Salt Lake City, Utah, United States

VA Portland Health Care System, Portland, OR; 🇺🇸 Portland, Oregon, United States