Lipoic Acid for Secondary Progressive Multiple Sclerosis (MS)

NCT01188811 | Completed Phase 2 Results DMC

• 1 other identifier: B7493-W
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis, Chronic Progressive

Keywords

Multiple Sclerosis; Multiple sclerosis, chronic progressive; Neuroprotective agents; Magnetic resonance imaging; Optical coherence tomography; Gait; Thioctic acid; Alpha-lipoic acid

Outcome Measures

Primary Outcomes (1)

• Brain Atrophy by MRI

  % change brain volume from baseline to year 2

Secondary Outcomes (2)

• Disability Measures: Mobility

  Change in Timed 25 Foot Walk from baseline to year 2

• Safety Measure: Adverse Events

  adverse events recorded from baseline to year 2

Study Arms (2)

Arm 1: lipoic acid

EXPERIMENTAL

28 subjects receive oral lipoic acid 1200mg daily

Drug: lipoic acid

Arm 2: placebo

PLACEBO COMPARATOR

28 subjects receive placebo daily

Drug: Placebo

Interventions

lipoic acid DRUG

1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation.

Also known as: alpha lipoic acid

Arm 1: lipoic acid

Placebo DRUG

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

Arm 2: placebo

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of SPMS
• Age 40-70 years
• Able to understand English and able to give informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Oregon Health and Science University: collaborator

Study Sites (1)

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97239, United States

Location

Related Publications (2)

• Loy BD, Fling BW, Horak FB, Bourdette DN, Spain RI. Effects of lipoic acid on walking performance, gait, and balance in secondary progressive multiple sclerosis. Complement Ther Med. 2018 Dec;41:169-174. doi: 10.1016/j.ctim.2018.09.006. Epub 2018 Sep 22.

  PMID: 30477834 DERIVED

• 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.

  PMID: 28680916 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive; Multiple Sclerosis

Interventions

Thioctic Acid

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Results Point of Contact

• Title: Rebecca Spain, MD, MSPH
• Organization: Oregon Health & Science University

spainr@ohsu.edu

503-494-5759

Study Officials

• Rebecca Spain, MD MSPH

  VA Portland Health Care System, Portland, OR

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2010
• First Posted: August 26, 2010
• Study Start: October 1, 2010
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: February 2, 2017
• Results First Posted: February 2, 2017

Record last verified: 2016-12

Locations

US (1)