View Clinical Trial (Medical Research Study)
Lipoic Acid for Neuroprotection in Secondary Progressive MS
| City: |
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Portland |
| State: |
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Oregon |
| Zip Code: |
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97201 |
| Conditions: |
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Multiple Sclerosis, Chronic Progressive |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| 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
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| NCT ID: |
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NCT01188811 |
| Primary Contact: |
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Principal Investigator Rebecca Spain, MD MSPH VA Medical Center, Portland
Elizabeth Heriza Phone: (503) 220-8262 ext. 54594 Email: elizabeth.heriza@va.gov
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| Backup Contact: |
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Email: spainr@ohsu.edu Rebecca Spain, MD MSPH Phone: (503) 346-0768
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| Location Contact: |
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Portland, Oregon 97201 United States
Elizabeth Heriza Phone: 503-220-8262 Email: elizabeth.heriza@va.gov
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 19, 2013 |
| Modifications to this listing: |
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