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Lipoic Acid for Progressive Multiple Sclerosis (MS)

This study is not yet open for participant recruitment.
Verified June 2017 by VA Office of Research and Development
Sponsor:
ClinicalTrials.gov Identifier:
NCT03161028
First Posted: May 19, 2017
Last Update Posted: June 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
The purpose of the study is to determine if lipoic acid can preserve mobility and protect the brain in progressive forms of multiple sclerosis.

Condition Intervention Phase
Multiple Sclerosis Drug: Lipoic acid Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lipoic Acid for the Treatment of Progressive Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Mobility: Timed 25 Foot Walk [ Time Frame: Change in Timed 25 Foot Walk from baseline to year 2 ]
    Change in Timed 25 Foot Walk from baseline to year 2


Secondary Outcome Measures:
  • Mobility: 2-minute timed walk [ Time Frame: Change in 2-minute timed walk from baseline to year 2 ]
    Change in 2-minute timed walk from baseline to year 2

  • Mobility: Fall count [ Time Frame: Change in number of falls recorded from baseline to year 2 ]
    Change in number of falls recorded from baseline to year 2

  • Brain Atrophy by MRI [ Time Frame: % change brain volume from baseline to year 2 ]
    % change brain volume from baseline to year 2


Other Outcome Measures:
  • Safety: laboratory safety monitoring, adverse event monitoring [ Time Frame: Adverse events and safety labs from baseline to year 2 ]
    Adverse events and safety labs from baseline to year 2


Estimated Enrollment: 100
Anticipated Study Start Date: November 1, 2017
Estimated Study Completion Date: April 1, 2021
Estimated Primary Completion Date: April 1, 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: Lipoic Acid
50 subjects receive oral lipoic acid 1200mg daily
Drug: Lipoic acid
1200 mg taken by mouth daily for two years starting on day one of the study and ending on the last day of study participation.
Other Name: Alpha-lipoic acid
Placebo Comparator: Arm 2: Placebo
50 subjects receive placebo daily
Drug: Placebo
The placebo comparator will be taken by mouth daily for two years starting on day one of the study and ending on the last day of study participation

Detailed Description:
This two-year study will determine if daily oral intake of lipoic acid will prove superior to placebo in reducing injury to the brain and maintaining mobility in progressive MS. Mobility will be assessed with the timed 25-foot walk test and 2-minute timed walk test as well as fall counts. Neuroprotection will be measured by the extent of brain volume loss seen on MRI.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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) 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.
  • 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.
  • Lipoic acid in the 30 days prior to enrolment.
  • Participation in the pilot LA in SPMS trial.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03161028


Contacts
Contact: Anna E Orban (800) 949-1004 anna.orban@va.gov

Locations
United States, Oregon
VA Portland Health Care System, Portland, OR Not yet recruiting
Portland, Oregon, United States, 97239
Contact: Anna E Orban    800-949-1004    anna.orban@va.gov   
Principal Investigator: Rebecca I. Spain, MD MSPH         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Rebecca I. Spain, MD MSPH VA Portland Health Care System, Portland, OR
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03161028     History of Changes
Other Study ID Numbers: B2682-R
First Submitted: May 18, 2017
First Posted: May 19, 2017
Last Update Posted: June 6, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by VA Office of Research and Development:
multiple sclerosis
magnetic resonance imaging
gait
neuroprotective agents
thioctic acid
alpha-lipoic acid
mobility
chronic progressive multiple sclerosis

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Thioctic Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances