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

Primary Purpose

Multiple Sclerosis

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Lipoic acid
Placebo
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring multiple sclerosis, magnetic resonance imaging, gait, neuroprotective agents, thioctic acid, alpha-lipoic acid, mobility, chronic progressive multiple sclerosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham
  • University of Colorado
  • Washington DC VA Medical Center, Washington, DC
  • VA Portland Health Care System, Portland, OR
  • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
  • University of Utah
  • VA Salt Lake City Health Care System, Salt Lake City, UT
  • University of Vermont
  • VA Puget Sound Health Care System Seattle Division, Seattle, WA
  • Swedish Medical Center
  • Ottawa Hospital Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm 1: Lipoic Acid

Arm 2: Placebo

Arm Description

59 subjects receive oral lipoic acid 1200mg daily

59 subjects receive placebo daily

Outcomes

Primary Outcome Measures

Mobility: Timed 25 Foot Walk
Change in Timed 25 Foot Walk from baseline to year 2

Secondary Outcome Measures

Mobility: 2-minute timed walk
Change in 2-minute timed walk from baseline to year 2
Mobility: Fall count
Change in number of falls recorded from baseline to year 2
Brain Atrophy by MRI
% change brain volume from baseline to year 2

Full Information

First Posted
May 18, 2017
Last Updated
January 31, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT03161028
Brief Title
Lipoic Acid for Progressive Multiple Sclerosis (MS)
Acronym
LAPMS
Official Title
Lipoic Acid for the Treatment of Progressive Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
multiple sclerosis, magnetic resonance imaging, gait, neuroprotective agents, thioctic acid, alpha-lipoic acid, mobility, chronic progressive multiple sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Lipoic Acid
Arm Type
Experimental
Arm Description
59 subjects receive oral lipoic acid 1200mg daily
Arm Title
Arm 2: Placebo
Arm Type
Placebo Comparator
Arm Description
59 subjects receive placebo daily
Intervention Type
Drug
Intervention Name(s)
Lipoic acid
Other Intervention Name(s)
Alpha-lipoic acid
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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 Measure Information:
Title
Mobility: Timed 25 Foot Walk
Description
Change in Timed 25 Foot Walk from baseline to year 2
Time Frame
Change in Timed 25 Foot Walk from baseline to year 2
Secondary Outcome Measure Information:
Title
Mobility: 2-minute timed walk
Description
Change in 2-minute timed walk from baseline to year 2
Time Frame
Change in 2-minute timed walk from baseline to year 2
Title
Mobility: Fall count
Description
Change in number of falls recorded from baseline to year 2
Time Frame
Change in number of falls recorded from baseline to year 2
Title
Brain Atrophy by MRI
Description
% change brain volume from baseline to year 2
Time Frame
% change brain volume from baseline to year 2
Other Pre-specified Outcome Measures:
Title
Safety: laboratory safety monitoring, adverse event monitoring
Description
Adverse events and safety labs from baseline to year 2
Time Frame
Adverse events and safety labs from baseline to year 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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) 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca I. Spain, MD MSPH
Organizational Affiliation
VA Portland Health Care System, Portland, OR
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Washington DC VA Medical Center, Washington, DC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Facility Name
VA Portland Health Care System, Portland, OR
City
Portland
State/Province
Oregon
ZIP/Postal Code
97207-2964
Country
United States
Facility Name
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84148
Country
United States
Facility Name
VA Salt Lake City Health Care System, Salt Lake City, UT
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84148
Country
United States
Facility Name
University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
VA Puget Sound Health Care System Seattle Division, Seattle, WA
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Ottawa Hospital Research Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Lipoic Acid for Progressive Multiple Sclerosis (MS)

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