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Lipoic Acid for Progressive Multiple Sclerosis (MS)

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ClinicalTrials.gov Identifier: NCT03161028
Recruitment Status : Not yet recruiting
First Posted : May 19, 2017
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
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 or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Lipoic acid Drug: Placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 118 participants
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
Estimated Study Start Date : July 1, 2018
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. 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

  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

  3. 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:
  1. 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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.
  • 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.

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: Cassidy A Taylor (503) 220-8262 Cassidy.Taylor@va.gov
Contact: Carin Waslo (503) 418-2141 waslo@ohsu.edu

Locations
United States, Alabama
University of Alabama at Birmingham Not yet recruiting
Birmingham, Alabama, United States, 35294
Contact: Kerry Howard    205-934-1885    kdhoward@uabmc.edu   
Contact: John Rinker II, MD       jrinker@uabmc.edu   
United States, District of Columbia
Washington DC VA Medical Center, Washington, DC Not yet recruiting
Washington, District of Columbia, United States, 20422
Contact: Heidi Maloni, PhD    202-745-8000 ext 57873    Heidi.Maloni@va.gov   
Contact: Mitchell T Wallin, MD    2027458146    mitchell.wallin@va.gov   
United States, Oregon
VA Portland Health Care System, Portland, OR Recruiting
Portland, Oregon, United States, 97239
Contact: Carin Waslo    503-418-2141    waslo@ohsu.edu   
Contact: Cassidy A Taylor    (503) 220-8262    Cassidy.Taylor@va.gov   
Principal Investigator: Rebecca I. Spain, MD MSPH         
United States, Utah
VA Salt Lake City Health Care System, Salt Lake City, UT Not yet recruiting
Salt Lake City, Utah, United States, 84148
Contact: Lilly Fagatele    801-585-9266    Lilly.Fagatele@hsc.utah.edu   
Contact: Mateo Paz Soldan, MD       miguel.pazsoldan@va.gov   
United States, Vermont
University of Vermont Not yet recruiting
Burlington, Vermont, United States, 05401
Contact: Roman Pettigrew    802-847-6039    Roman.Pettigrew@uvmhealth.org   
Contact: Andrew Solomon, MD    8028474589    Andrew.Solomon@uvmhealth.org   
United States, Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA Not yet recruiting
Seattle, Washington, United States, 98108
Contact: Alicia Sloan, MSW    800-329-8387 ext 63593    alicia.sloan@va.gov   
Contact: Jodie Haselkorn, MD       Jodie.Haselkorn@va.gov   
Swedish Medical Center Not yet recruiting
Seattle, Washington, United States, 98122
Contact: Laura Johnson    206-320-7115    laura.johnson3@swedish.org   
Contact: Pavle Repovic, MD    2063202200    Pavle.Repovic@swedish.org   
Canada, Ontario
Ottawa Hospital Research Institute Not yet recruiting
Ottawa, Ontario, Canada, K1Y 4E9
Contact: Carol Freedman    613-737-8104 ext 2    cfreedman@toh.ca   
Contact: Mark Freedman, MD       mfreedman@toh.ca   
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Rebecca I. Spain, MD MSPH VA Portland Health Care System, Portland, OR

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03161028     History of Changes
Other Study ID Numbers: B2682-R
First Posted: May 19, 2017    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018
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