Lipoic Acid for Secondary Progressive Multiple Sclerosis (MS)

Multiple Sclerosis, Chronic Progressive Clinical Trial

Official title:

Lipoic Acid for Neuroprotection in Secondary Progressive MS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01188811
• Other study ID #: B7493-W
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 25, 2010
• Last updated: February 11, 2016
• Start date: October 2010
• Est. completion date: August 2015

Study information

• Verified date: February 2016
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Sclerosis

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	VA Portland Health Care System, Portland, OR	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain atrophy by MRI		Baseline, years 1 and 2.	No
Secondary	Disability measures: gait, quality of life and neurologic status		baseline, months 0, 6, 12, 18 and 24	No
Secondary	Safety measures: adverse events, safety labs		screen, baseline, months 0, 3, 6, 12, 18, 24	Yes