Phase 3
N=54
Lipoic Acid for Secondary Progressive Multiple Sclerosis (MS)
Multiple Sclerosis, Chronic Progressive
Bottom Line
View on ClinicalTrials.gov: NCT01188811 ↗Enrolled (actual)
54
Serious AEs
27.8%
Results posted
Feb 2017
Primary outcome: Primary: Brain Atrophy by MRI — -0.4; -1.3 whole brain percent volume change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- lipoic acid (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brain Atrophy by MRI |
-0.4; -1.3 | — |
| SECONDARY Disability Measures: Mobility |
-1.0; 0.1 | — |
| SECONDARY Safety Measure: Adverse Events |
81; 69; 9; 6 | — |
Summary
The purpose of the study is to determine if lipoic acid can protect the brain and slow disability in secondary progressive multiple sclerosis.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01188811). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.