Lipoic Acid for Secondary Progressive Multiple Sclerosis (MS)
Primary Purpose
Multiple Sclerosis, Chronic Progressive
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
lipoic acid
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis, Chronic Progressive focused on measuring Multiple Sclerosis, Multiple sclerosis, chronic progressive, Neuroprotective agents, Magnetic resonance imaging, Optical coherence tomography, Gait, Thioctic acid, Alpha-lipoic acid
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of SPMS
- Age 40-70 years
- Able to understand English and able to give informed consent
Exclusion Criteria:
- Unable to undergo MRI testing
- For ambulatory subjects only, a self-reported medical or neurological condition other than MS that is a cause of progressive or fluctuating problems that affect walking(e.g. worsening neuropathy, uncontrolled lower extremity arthritis, uncontrolled heart or lung disease)
- For ambulatory subjects only, fixed and/or stable conditions of less than 1 years duration that affect walking (e.g. joint replacement, lumbar stenosis, alcoholism, stroke, etc.)
- Pregnant or breast-feeding.
- Current major disease or disorder other than MS (such as cancer, kidney, heart or lung disease, post-traumatic stress disorder) that may interfere with study procedures
- Natalizumab, mitoxantrone, azathioprine taken in the last 12 months
- Other immunosuppressants or chemotherapies taken in the last 12 months
- Scheduled (every 3 months or more frequently) IV steroids used in the last 12 months
- IV or oral steroids taken in the past 60 days.
- Lipoic acid taken in the past 60 days.
- Subject has insulin-dependent diabetes or is not controlled on oral diabetes medications
Sites / Locations
- VA Portland Health Care System, Portland, OR
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Arm 1: lipoic acid
Arm 2: placebo
Arm Description
28 subjects receive oral lipoic acid 1200mg daily
28 subjects receive placebo daily
Outcomes
Primary Outcome Measures
Brain Atrophy by MRI
Secondary Outcome Measures
Disability Measures: Mobility
Safety Measure: Adverse Events
Full Information
NCT ID
NCT01188811
First Posted
August 25, 2010
Last Updated
December 7, 2016
Sponsor
VA Office of Research and Development
Collaborators
Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT01188811
Brief Title
Lipoic Acid for Secondary Progressive Multiple Sclerosis (MS)
Official Title
Lipoic Acid for Neuroprotection in Secondary Progressive MS
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
Oregon Health and Science University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the study is to determine if lipoic acid can protect the brain and slow disability in secondary progressive multiple sclerosis.
Detailed Description
There are no approved medications that are neuroprotective or able to slow disability accumulation in secondary progressive multiple sclerosis (SPMS). This two-year study will determine if daily oral intake of lipoic acid, a natural supplement, will prove superior to placebo in reducing injury to the brain and reducing disability progression in SPMS. Neuroprotection will be measured by the extent of brain volume loss seen on MRI, and disability will be measured by neurological status and quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Chronic Progressive
Keywords
Multiple Sclerosis, Multiple sclerosis, chronic progressive, Neuroprotective agents, Magnetic resonance imaging, Optical coherence tomography, Gait, Thioctic acid, Alpha-lipoic acid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: lipoic acid
Arm Type
Experimental
Arm Description
28 subjects receive oral lipoic acid 1200mg daily
Arm Title
Arm 2: placebo
Arm Type
Placebo Comparator
Arm Description
28 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 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 starting on day one of the study and ending on the last day of study participation
Primary Outcome Measure Information:
Title
Brain Atrophy by MRI
Time Frame
% change brain volume from baseline to year 2
Secondary Outcome Measure Information:
Title
Disability Measures: Mobility
Time Frame
Change in Timed 25 Foot Walk from baseline to year 2
Title
Safety Measure: Adverse Events
Time Frame
adverse events recorded from baseline to year 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of SPMS
Age 40-70 years
Able to understand English and able to give informed consent
Exclusion Criteria:
Unable to undergo MRI testing
For ambulatory subjects only, a self-reported medical or neurological condition other than MS that is a cause of progressive or fluctuating problems that affect walking(e.g. worsening neuropathy, uncontrolled lower extremity arthritis, uncontrolled heart or lung disease)
For ambulatory subjects only, fixed and/or stable conditions of less than 1 years duration that affect walking (e.g. joint replacement, lumbar stenosis, alcoholism, stroke, etc.)
Pregnant or breast-feeding.
Current major disease or disorder other than MS (such as cancer, kidney, heart or lung disease, post-traumatic stress disorder) that may interfere with study procedures
Natalizumab, mitoxantrone, azathioprine taken in the last 12 months
Other immunosuppressants or chemotherapies taken in the last 12 months
Scheduled (every 3 months or more frequently) IV steroids used in the last 12 months
IV or oral steroids taken in the past 60 days.
Lipoic acid taken in the past 60 days.
Subject has insulin-dependent diabetes or is not controlled on oral diabetes medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Spain, MD MSPH
Organizational Affiliation
VA Portland Health Care System, Portland, OR
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Portland Health Care System, Portland, OR
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28680916
Citation
Spain R, Powers K, Murchison C, Heriza E, Winges K, Yadav V, Cameron M, Kim E, Horak F, Simon J, Bourdette D. Lipoic acid in secondary progressive MS: A randomized controlled pilot trial. Neurol Neuroimmunol Neuroinflamm. 2017 Jun 28;4(5):e374. doi: 10.1212/NXI.0000000000000374. eCollection 2017 Sep.
Results Reference
derived
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Lipoic Acid for Secondary Progressive Multiple Sclerosis (MS)
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