Status:
COMPLETED
Lipoic Acid for Secondary Progressive Multiple Sclerosis (MS)
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
Oregon Health and Science University
Conditions:
Multiple Sclerosis, Chronic Progressive
Eligibility:
All Genders
40-70 years
Phase:
PHASE2
PHASE3
Brief Summary
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
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 ...
Eligibility Criteria
Inclusion
- Diagnosis of SPMS
- Age 40-70 years
- Able to understand English and able to give informed consent
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT01188811
Start Date
October 1 2010
End Date
August 1 2015
Last Update
February 2 2017
Active Locations (1)
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1
VA Portland Health Care System, Portland, OR
Portland, Oregon, United States, 97239