Lipoic Acid for Secondary Progressive Multiple Sclerosis (MS)
What it found
The main measure showed a statistically significant benefit.
“After 2 years, the annualized PCBV was significantly less in the LA arm compared with placebo (-0.21 [standard error of the coefficient estimate (SEE) 0.14] vs -0.65 [SEE 0.10], 95% confidence interval [CI] 0.157-0.727, p = 0.002).”Read by software from the paper's abstract
change in annualized percent change brain volume (PCBV) · 2 years
| Group | n | Value |
|---|---|---|
| Lipoic acid | 27 | -0.21 (SEE 0.14) |
| Placebo | 24 | -0.65 (SEE 0.10) |
p = 0.002
Read by software from the paper's abstract
What was tested
Treatment tested
- Thioctic acid
Placebo or sham
- Placebo
Results by group
Brain Atrophy by MRI
% change brain volume from baseline to year 2
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Lipoic Acid | -0.4 whole brain percent volume change | 0.7 (Standard Deviation) | 20 |
| Placebo | -1.3 whole brain percent volume change | 1.1 (Standard Deviation) | 24 |
Lipoic Acid
Placebo
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Lipoic Acid | 28 | 9 (32.1%) | |
| Placebo | 26 | 6 (23.1%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Brain Atrophy by MRI
% change brain volume from baseline to year 2
MRI lesionsBrain volume loss
Other measures (2)
Disability Measures: Mobility
Change in Timed 25 Foot Walk from baseline to year 2
Walking and mobilitySafety Measure: Adverse Events
adverse events recorded from baseline to year 2
Safety
Who could take part
Progressive MS · 40 to 70
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The purpose of the study is to determine if lipoic acid can protect the brain and slow disability in secondary progressive multiple sclerosis.
Papers
Results
Lipoic acid supplementation associated with neural epidermal growth factor-like 1 (NELL1)-associated membranous nephropathy.Kidney Int · 2021
Results
Effects of lipoic acid on walking performance, gait, and balance in secondary progressive multiple sclerosis.Complement Ther Med · 2018
Results
Spain R, Powers K, Murchison C, Heriza E, Winges K, Yadav V, Cameron M, Kim E, Horak F, Simon J, Bourdette D. Lipoic acid in secondary progressive MS: A randomized controlled pilot trial. Neurol Neuroimmunol Neuroinflamm. 2017 Jun 28;4(5):e374. doi: 10.1212/NXI.0000000000000374. eCollection 2017 Sep.After 2 years, the annualized PCBV was significantly less in the LA arm compared with placebo (-0.21 [standard error of the coefficient estimate (SEE) 0.14] vs -0.65 [SEE 0.10], 95% confidence interval [CI] 0.157-0.727, p = 0.002).
Read by software from the paper's abstract
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History
Started
Oct 2010
Main results due
Aug 2015
Finished
Aug 2015
Results posted
Feb 2017
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