Purpose

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

Condition

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.
  • Current Grade 1 or greater abnormal creatinine or glomerular filtration rate (GFR) <55.
  • 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

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm 1: Lipoic Acid
59 subjects receive oral lipoic acid 1200mg daily
  • 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.
    Other names:
    • Alpha-lipoic acid
Placebo Comparator
Arm 2: Placebo
59 subjects receive placebo daily
  • Drug: 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

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294
Contact:
Kerry Howard
205-934-1885
kdhoward@uabmc.edu

More Details

NCT ID
NCT03161028
Status
Recruiting
Sponsor
VA Office of Research and Development

Study Contact

Cassidy A Taylor
(503) 220-8262
Cassidy.Taylor@va.gov

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.