Phase 2
N=115
Lipoic Acid for Progressive Multiple Sclerosis (MS)
Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT03161028 ↗Enrolled (actual)
115
Serious AEs
15.7%
Results posted
Mar 2025
Primary outcome: Primary: Change in Mobility: Timed 25 Foot Walk — -0.39; -0.30 feet per second — p=0.51
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lipoic acid (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mobility: Timed 25 Foot Walk |
-0.39; -0.30 | 0.51 |
| SECONDARY Change in Mobility: 2-minute Timed Walk |
-7.25; -8.02 | 0.902 |
| SECONDARY Mobility: Fall Count |
0.65; 0.63 | 0.90 |
| SECONDARY Brain Atrophy by MRI |
-0.58; -7.18 | 0.084 |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03161028). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.