Clinical trial NCT01188811: Lipoic Acid for Secondary Progressive Multiple Sclerosis (MS)
Official title: Lipoic Acid for Neuroprotection in Secondary Progressive MS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
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
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Oregon Health and Science University
First posted: 2010-08-26
Enrollment: 54
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Brain Atrophy by MRI
timeFrame: % change brain volume from baseline to year 2
Secondary outcomes:
measure: Disability Measures: Mobility
timeFrame: Change in Timed 25 Foot Walk from baseline to year 2
measure: Safety Measure: Adverse Events
timeFrame: adverse events recorded from baseline to year 2
Other outcomes:
Locations:
city: Portland
country: United States
facility: VA Portland Health Care System, Portland, OR
state: Oregon
Study officials:
affiliation: VA Portland Health Care System, Portland, OR
name: Rebecca Spain, MD MSPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.