Lipoic Acid for Progressive Multiple Sclerosis (MS)

Multiple Sclerosis Clinical Trial

— LAPMS  

Official title:

Lipoic Acid for the Treatment of Progressive Multiple Sclerosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03161028
• Other study ID #: B2682-R
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 1, 2018
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 115
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Sclerosis

Intervention

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.
• 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

Locations

Country	Name	City	State
Canada	Ottawa Hospital Research Institute	Ottawa	Ontario
United States	University of Colorado	Aurora	Colorado
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of Vermont	Burlington	Vermont
United States	VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX	Dallas	Texas
United States	VA Portland Health Care System, Portland, OR	Portland	Oregon
United States	University of Utah	Salt Lake City	Utah
United States	VA Salt Lake City Health Care System, Salt Lake City, UT	Salt Lake City	Utah
United States	Swedish Medical Center	Seattle	Washington
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	Brain Atrophy by MRI	% change brain volume from baseline to year 2	% change brain volume from baseline to year 2