Lipoic Acid for Secondary 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 protect the brain and slow disability in secondary progressive multiple sclerosis.

Detailed Description
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There are no approved medications that are neuroprotective or able to slow disability accumulation in secondary progressive multiple sclerosis (SPMS). This two-year study will determine if daily oral intake of lipoic acid, a natural supplement, will prove superior to placebo in reducing injury to the brain and reducing disability progression in SPMS. Neuroprotection will be measured by the extent of brain volume loss seen on MRI, and disability will be measured by neurological status and quality of life.

Official Title
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Lipoic Acid for Neuroprotection in Secondary Progressive MS

Conditions
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Multiple Sclerosis, Chronic Progressive

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 SPMS Age 40-70 years Able to understand English and able to give informed consent Exclusion Criteria: Unable to undergo MRI testing For ambulatory subjects only, a self-reported medical or neurological condition other than MS that is a cause of progressive or fluctuating problems that affect walking(e.g. worsening neuropathy, uncontrolled lower extremity arthritis, uncontrolled heart or lung disease) For ambulatory subjects only, fixed and/or stable conditions of less than 1 years duration that affect walking (e.g. joint replacement, lumbar stenosis, alcoholism, stroke, etc.) Pregnant or breast-feeding. Current major disease or disorder other than MS (such as cancer, kidney, heart or lung disease, post-traumatic stress disorder) that may interfere with study procedures Natalizumab, mitoxantrone, azathioprine taken in the last 12 months Other immunosuppressants or chemotherapies taken in the last 12 months Scheduled (every 3 months or more frequently) IV steroids used in the last 12 months IV or oral steroids taken in the past 60 days. Lipoic acid taken in the past 60 days. Subject has insulin-dependent diabetes or is not controlled on oral diabetes medications

Ages Eligible for Study
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Minimum Age: 40 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>28 subjects receive oral lipoic acid 1200mg daily | Drug: lipoic acid<br>* 1200 mg taken by mouth daily 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>28 subjects receive placebo daily | Drug: Placebo<br>* The placebo comparator will be taken by mouth daily 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 |
| --- | --- | --- |
| Brain Atrophy by MRI |  | % change brain volume from baseline to year 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability Measures: Mobility |  | Change in Timed 25 Foot Walk from baseline to year 2 | 
| Safety Measure: Adverse Events |  | adverse events recorded from baseline to year 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gait, Multiple Sclerosis, Multiple sclerosis, chronic progressive, Neuroprotective agents, Magnetic resonance imaging, Optical coherence tomography, Thioctic acid, Alpha-lipoic acid