Lipoic Acid for Progressive Multiple Sclerosis (MS) (LAPMS)

Lipoic Acid for the Treatment of Progressive Multiple Sclerosis

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

Study Overview

• Status: Active, not recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: Lipoic acid; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 115
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4E9
      • Ottawa Hospital Research Institute
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
  • District of Columbia
    • Washington, District of Columbia, United States, 20422
      • Washington DC VA Medical Center, Washington, DC
  • Oregon
    • Portland, Oregon, United States, 97207-2964
      • VA Portland Health Care System, Portland, OR
  • Texas
    • Dallas, Texas, United States, 75216
      • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
  • Utah
    • Salt Lake City, Utah, United States, 84148
      • VA Salt Lake City Health Care System, Salt Lake City, UT
    • Salt Lake City, Utah, United States, 84148
      • University of Utah
  • Vermont
    • Burlington, Vermont, United States, 05401
      • University of Vermont
  • Washington
    • Seattle, Washington, United States, 98108
      • VA Puget Sound Health Care System Seattle Division, Seattle, WA
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Brain Atrophy by MRI	% change brain volume from baseline to year 2	% change brain volume from baseline to year 2

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Rebecca I. Spain, MD MSPH, VA Portland Health Care System, Portland, OR

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): December 31, 2023
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: May 18, 2017
• First Submitted That Met QC Criteria: May 18, 2017
• First Posted (Actual): May 19, 2017

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: magnetic resonance imaging; gait; multiple sclerosis; mobility; alpha-lipoic acid; thioctic acid; neuroprotective agents; chronic progressive multiple sclerosis
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Disease Attributes; Chronic Disease; Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Vitamin B Complex; Thioctic Acid
• Other Study ID Numbers: B2682-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes