Lipoic Acid for Secondary Progressive Multiple Sclerosis (MS)
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ClinicalTrials.gov Identifier: NCT01188811 |
Recruitment Status :
Completed
First Posted : August 26, 2010
Results First Posted : February 2, 2017
Last Update Posted : February 2, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Sclerosis, Chronic Progressive | Drug: lipoic acid Drug: Placebo | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 54 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Lipoic Acid for Neuroprotection in Secondary Progressive MS |
Study Start Date : | October 2010 |
Actual Primary Completion Date : | August 2015 |
Actual Study Completion Date : | August 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm 1: lipoic acid
28 subjects receive oral lipoic acid 1200mg daily
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Drug: lipoic acid
1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation.
Other Name: alpha lipoic acid |
Placebo Comparator: Arm 2: placebo
28 subjects receive placebo daily
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Drug: Placebo
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 |
- Brain Atrophy by MRI [ Time Frame: % change brain volume from baseline to year 2 ]
- Disability Measures: Mobility [ Time Frame: Change in Timed 25 Foot Walk from baseline to year 2 ]
- Safety Measure: Adverse Events [ Time Frame: adverse events recorded from baseline to year 2 ]

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Ages Eligible for Study: | 40 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01188811
United States, Oregon | |
VA Portland Health Care System, Portland, OR | |
Portland, Oregon, United States, 97239 |
Principal Investigator: | Rebecca Spain, MD MSPH | VA Portland Health Care System, Portland, OR |
Responsible Party: | VA Office of Research and Development |
ClinicalTrials.gov Identifier: | NCT01188811 |
Other Study ID Numbers: |
B7493-W |
First Posted: | August 26, 2010 Key Record Dates |
Results First Posted: | February 2, 2017 |
Last Update Posted: | February 2, 2017 |
Last Verified: | December 2016 |
Multiple Sclerosis Multiple sclerosis, chronic progressive Neuroprotective agents Magnetic resonance imaging |
Optical coherence tomography Gait Thioctic acid Alpha-lipoic acid |
Multiple Sclerosis Multiple Sclerosis, Chronic Progressive Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases |
Immune System Diseases Thioctic Acid Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients |