CompletedPhase 2Progressive MSNCT03161028

What it found

Missed its main goal

The main measure did not show a significant benefit.

MeasureEstimate95% CIp
Change in Mobility: Timed 25 Foot Walk 0.51

Statistical analysis as posted on ClinicalTrials.gov.

What was tested

Treatment tested

  • Thioctic acid

Placebo or sham

  • Placebo

Results by group

Change in Mobility: Timed 25 Foot Walk

24 months

GroupValueIntervalNumber analysed
Lipoic Acid-0.39 feet per second-0.58–-0.254
Placebo-0.30 feet per second-0.46–-0.1461

Lipoic Acid

-0.39

Placebo

-0.3

p = 0.51

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Lipoic Acid5411 (20.4%)0
Placebo617 (11.5%)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

  • Change in Mobility: Timed 25 Foot Walk

    24 months

    Disability progressionWalking and mobility

Other measures (3)

  • Change in Mobility: 2-minute Timed Walk

    24 months

    Walking and mobility
  • Mobility: Fall Count

    24 months

    Walking and mobility
  • Brain Atrophy by MRI

    24 months

    MRI lesionsBrain volume loss

Who could take part

Progressive MS · 18 to 70

Inclusion Criteria: * Diagnosis of progressive MS as defined by the study * Able to give informed consent and to adhere to study procedures. * Expanded Disability Status Scale (EDSS) 3.0 - 6.5: ambulatory for at least 20 meters without rest and use of bilateral aids (canes, crutches, walker) or better. Exclusion Criteria: * A self-reported medical or neurological problem other than MS that is a cause of progressive or fluctuating gait dysfunction * Unable to undergo MRI * Unable to follow directions in English as standardized scales are not all validated in other languages. * Current major disease or disorder other than MS (e.g., cancer, renal disease, end-stage cardiopulmonary disease, post-traumatic stress disorder, etc.) that may interfere with study procedures. Note: Stable abnormal laboratory values of no more than Grade 1 determined to not be of clinical significance to the primary treating physician for that condition may be permitted per local site investigator discretion. * Pregnant or breast-feeding. * Insulin-dependent diabetes or diabetes not controlled on oral diabetes medications. * Scheduled (every 3 months or more frequently) IV or oral steroids in the year prior to enrolment. * IV or oral steroids in the 60 days prior to enrolment. * Use of LA in the prior 2 years exceeding the equivalent of 1200mg daily for 3 months. * Participation in the pilot LA in SPMS trial.

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 preserve mobility and protect the brain in progressive forms of multiple sclerosis.

Papers

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Related trials

History

    1. Started

      Aug 2018

    2. Main results due

      Dec 2023

    3. Finished

      Jun 2024

    4. Results posted

      Mar 2025

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