Lipoic Acid for Progressive Multiple Sclerosis (MS)

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

Detailed Description
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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.

Official Title
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Lipoic Acid for the Treatment of Progressive Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: Lipoic acid
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: Lipoic Acid<br>59 subjects receive oral lipoic acid 1200mg daily | Drug: Lipoic acid<br>* 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.<br>* Other names: Alpha-lipoic acid;|
| Placebo Comparator: Arm 2: Placebo<br>59 subjects receive placebo daily | Drug: Placebo<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multiple sclerosis, magnetic resonance imaging, gait, neuroprotective agents, thioctic acid, alpha-lipoic acid, mobility, chronic progressive multiple sclerosis