LAPMS: Lipoic Acid for Progressive Multiple Sclerosis (MS)

Sponsor

VA Office of Research and Development (U.S. Fed)

Overall Status

Active, not recruiting

CT.gov ID

NCT03161028

Collaborator

(none)

115

Enrollment

Locations

Arms

Anticipated Duration (Months)

10.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Drug: Lipoic acid Drug: Placebo	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

115 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Lipoic Acid for the Treatment of Progressive Multiple Sclerosis

Actual Study Start Date :

Jul 1, 2018

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	University of Colorado	Aurora	Colorado	United States	80045
3	Washington DC VA Medical Center, Washington, DC	Washington	District of Columbia	United States	20422
4	VA Portland Health Care System, Portland, OR	Portland	Oregon	United States	97239
5	VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX	Dallas	Texas	United States	75216
6	University of Utah	Salt Lake City	Utah	United States	84148
7	VA Salt Lake City Health Care System, Salt Lake City, UT	Salt Lake City	Utah	United States	84148
8	University of Vermont	Burlington	Vermont	United States	05401
9	VA Puget Sound Health Care System Seattle Division, Seattle, WA	Seattle	Washington	United States	98108
10	Swedish Medical Center	Seattle	Washington	United States	98122
11	Ottawa Hospital Research Institute	Ottawa	Ontario	Canada	K1Y 4E9