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Lipoic Acid for Secondary Progressive Multiple Sclerosis (MS)

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ClinicalTrials.gov Identifier: NCT01188811
Recruitment Status : Completed
First Posted : August 26, 2010
Results First Posted : February 2, 2017
Last Update Posted : February 2, 2017
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE August 25, 2010
First Posted Date  ICMJE August 26, 2010
Results First Submitted Date  ICMJE June 24, 2016
Results First Posted Date  ICMJE February 2, 2017
Last Update Posted Date February 2, 2017
Study Start Date  ICMJE October 2010
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2016)
Brain Atrophy by MRI [ Time Frame: % change brain volume from baseline to year 2 ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 25, 2010)
Brain atrophy by MRI (SIENA) [ Time Frame: 24 months ]
Change History Complete list of historical versions of study NCT01188811 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2016)
  • Disability Measures: Mobility [ Time Frame: 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2010)
  • Cervical spinal cord atrophy by MRI (SIENA) [ Time Frame: 24 months ]
  • Gait [ Time Frame: 24 months ]
  • Quality of Life [ Time Frame: 24 months ]
  • optical coherence tomography [ Time Frame: 24 months ]
    Retinal nerve fiber layer atrophy will be measured by collecting OCT readings over 24 months.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lipoic Acid for Secondary Progressive Multiple Sclerosis (MS)
Official Title  ICMJE Lipoic Acid for Neuroprotection in Secondary Progressive MS
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis, Chronic Progressive
Intervention  ICMJE
  • 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 Name: alpha lipoic acid
  • 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
Study Arms  ICMJE
  • Experimental: Arm 1: lipoic acid
    28 subjects receive oral lipoic acid 1200mg daily
    Intervention: Drug: lipoic acid
  • Placebo Comparator: Arm 2: placebo
    28 subjects receive placebo daily
    Intervention: Drug: Placebo
Publications * 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.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: December 7, 2016)
54
Original Estimated Enrollment  ICMJE
 (submitted: August 25, 2010)
56
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01188811
Other Study ID Numbers  ICMJE B7493-W
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Oregon Health and Science University
Investigators  ICMJE
Principal Investigator: Rebecca Spain, MD MSPH VA Portland Health Care System, Portland, OR
PRS Account VA Office of Research and Development
Verification Date December 2016

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