Lipoic Acid for Secondary Progressive Multiple Sclerosis (MS)

VA Office of Research and Development

Status and phase

Completed

Phase 3

Phase 2

Conditions

Multiple Sclerosis, Chronic Progressive

Treatments

Drug: Placebo

Drug: lipoic acid

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT01188811

B7493-W

Details and patient eligibility

About

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

Full 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.

Enrollment

54 patients

Sex

All

Ages

40 to 70 years old

Volunteers

No Healthy Volunteers

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