Clinical Trial: Lipoic Acid for Secondary Progressive Multiple Sclerosis (MS)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Lipoic Acid for Neuroprotection in Secondary Progressive MS
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 Summary: 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.
Sponsor: VA Office of Research and Development
Current Primary Outcome: Brain Atrophy by MRI [ Time Frame: % change brain volume from baseline to year 2 ]
Original Primary Outcome: Brain atrophy by MRI (SIENA) [ Time Frame: 24 months ]
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome:
- Cervical spinal cord atrophy by MRI (SIENA) [ Time Frame: 24 months ]
- Gait [ Time Frame: 24 months ]
- Quality of Life [ Time Frame: 24 months ]
- optical coherence tomography [ Time Frame: 24 months ]Retinal nerve fiber layer atrophy will be measured by collecting OCT readings over 24 months.
Information By: VA Office of Research and Development
Dates:
Date Received: August 25, 2010
Date Started: October 2010
Date Completion:
Last Updated: December 7, 2016
Last Verified: December 2016
