Lipoic Acid for Progressive Multiple Sclerosis (MS)

• Status: Recruiting
• Trial end date: 2023-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Treatments: Thioctic Acid

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.