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Lipoic Acid for Progressive Multiple Sclerosis (MS) (LAPMS)

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ClinicalTrials.gov Identifier: NCT03161028
Recruitment Status : Recruiting
First Posted : May 19, 2017
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE May 18, 2017
First Posted Date  ICMJE May 19, 2017
Last Update Posted Date February 20, 2020
Actual Study Start Date  ICMJE July 1, 2018
Estimated Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 23, 2017)
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
Original Other Pre-specified Outcome Measures
 (submitted: May 18, 2017)
Safety and tolerability of lipoic acid in people with progressive MS [ Time Frame: Adverse events and safety labs from baseline to year 2 ]
Adverse events and safety labs from baseline to year 2
 
Descriptive Information
Brief Title  ICMJE Lipoic Acid for Progressive Multiple Sclerosis (MS)
Official Title  ICMJE Lipoic Acid for the Treatment of Progressive Multiple Sclerosis
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Arm 1: Lipoic Acid
    59 subjects receive oral lipoic acid 1200mg daily
    Intervention: Drug: Lipoic acid
  • Placebo Comparator: Arm 2: Placebo
    59 subjects receive placebo daily
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 8, 2017)
118
Original Estimated Enrollment  ICMJE
 (submitted: May 18, 2017)
100
Estimated Study Completion Date  ICMJE April 1, 2021
Estimated Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lauren Cameron (503) 494-9548 camerola@ohsu.edu
Contact: Carin Waslo (503) 418-2141 waslo@ohsu.edu
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03161028
Other Study ID Numbers  ICMJE B2682-R
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rebecca I. Spain, MD MSPH VA Portland Health Care System, Portland, OR
PRS Account VA Office of Research and Development
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP