Lipoic Acid for Secondary Progressive Multiple Sclerosis (MS)

December 7, 2016 updated by: VA Office of Research and Development

Lipoic Acid for Neuroprotection in Secondary Progressive MS

The purpose of the study is to determine if lipoic acid can protect the brain and slow disability in secondary progressive multiple sclerosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • VA Portland Health Care System, Portland, OR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: lipoic acid
28 subjects receive oral lipoic acid 1200mg daily
Drug: lipoic acid
1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation.
Other Names:
  • alpha lipoic acid
Placebo Comparator: Arm 2: placebo
28 subjects receive placebo daily
Drug: Placebo
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Brain Atrophy by MRI
Time Frame: % change brain volume from baseline to year 2
% change brain volume from baseline to year 2

Secondary Outcome Measures

Outcome Measure
Time Frame
Disability Measures: Mobility
Time Frame: Change in Timed 25 Foot Walk from baseline to year 2
Change in Timed 25 Foot Walk from baseline to year 2
Safety Measure: Adverse Events
Time Frame: adverse events recorded from baseline to year 2
adverse events recorded from baseline to year 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Collaborators

Oregon Health and Science University

Investigators

  • Principal Investigator: Rebecca Spain, MD MSPH, VA Portland Health Care System, Portland, OR

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

August 25, 2010

First Submitted That Met QC Criteria

August 25, 2010

First Posted (Estimate)

August 26, 2010

Study Record Updates

Last Update Posted (Estimate)

February 2, 2017

Last Update Submitted That Met QC Criteria

December 7, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B7493-W

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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