Lipoic Acid for Secondary Progressive Multiple Sclerosis (MS)

• 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: VA Office of Research and Development
• Collaborator: Oregon Health and Science University
• Information provided by (Responsible Party): VA Office of Research and Development

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.

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

• 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

Arms and Interventions

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

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

• 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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
• 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:

Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis; 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; Nutrients; Growth Substances