Phase 3
Completed N=54
Lipoic Acid for Secondary Progressive Multiple Sclerosis (MS)
Multiple Sclerosis, Chronic Progressive
Source: ClinicalTrials.gov NCT01188811 ↗
Enrolled (actual)
54
Serious AEs
27.8%
Results posted
Feb 2017
Primary outcomePrimary: Brain Atrophy by MRI — -0.4; -1.3 whole brain percent volume change
◆ Published Evidence
Highly cited
142citations · ~16 / year
Lipoic acid in secondary progressive MS: A randomized controlled pilot trial.
Summary
The purpose of the study is to determine if lipoic acid can protect the brain and slow disability in secondary progressive multiple sclerosis.
Linked Publications (2)
-
Lipoic acid in secondary progressive MS: A randomized controlled pilot trial.
-
Effects of lipoic acid on walking performance, gait, and balance in secondary progressive multiple sclerosis.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.