Lipoic Acid for Secondary Progressive Multiple Sclerosis (MS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01188811
First received: August 25, 2010
Last updated: May 23, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Multiple Sclerosis, Chronic Progressive
Drug: lipoic acid
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lipoic Acid for Neuroprotection in Secondary Progressive MS

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Brain atrophy by MRI [ Time Frame: Baseline, years 1 and 2. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disability measures: gait, quality of life and neurologic status [ Time Frame: baseline, months 0, 6, 12, 18 and 24 ] [ Designated as safety issue: No ]
  • Safety measures: adverse events, safety labs [ Time Frame: screen, baseline, months 0, 3, 6, 12, 18, 24 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 56
Study Start Date: October 2010
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
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
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

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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01188811

Locations
United States, Oregon
VA Medical Center, Portland
Portland, Oregon, United States, 97201
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Rebecca Spain, MD MSPH VA Medical Center, Portland
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01188811     History of Changes
Other Study ID Numbers: B7493-W
Study First Received: August 25, 2010
Last Updated: May 23, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Department of Veterans Affairs:
Multiple Sclerosis
Multiple sclerosis, chronic progressive
Neuroprotective agents
Magnetic resonance imaging
Optical coherence tomography
Gait
Thiotic acid
Alpha-lipoic acid

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

ClinicalTrials.gov processed this record on July 24, 2014