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Trial record 1 of 1 for:    NCT01188811
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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Chronic Progressive Drug: lipoic acid Drug: Placebo Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lipoic Acid for Neuroprotection in Secondary Progressive MS
Study Start Date : October 2010
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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


Outcome Measures
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Primary Outcome Measures :
  1. Brain Atrophy by MRI [ Time Frame: % change brain volume from baseline to year 2 ]

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

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01188811


Locations
United States, Oregon
VA Portland Health Care System, Portland, OR
Portland, Oregon, United States, 97239
Sponsors and Collaborators
VA Office of Research and Development
Oregon Health and Science University
Investigators
Principal Investigator: Rebecca Spain, MD MSPH VA Portland Health Care System, Portland, OR
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01188811     History of Changes
Other Study ID Numbers: B7493-W
First Posted: August 26, 2010    Key Record Dates
Results First Posted: February 2, 2017
Last Update Posted: February 2, 2017
Last Verified: December 2016

Keywords provided by VA Office of Research and Development:
Multiple Sclerosis
Multiple sclerosis, chronic progressive
Neuroprotective agents
Magnetic resonance imaging
 Optical coherence tomography
Gait
Thioctic acid
Alpha-lipoic acid

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
 Thioctic Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances