Clinical trial NCT03161028: Lipoic Acid for Progressive Multiple Sclerosis (MS)
Official title: Lipoic Acid for the Treatment of Progressive Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
magnetic resonance imaging
gait
neuroprotective agents
thioctic acid
alpha-lipoic acid
mobility
chronic progressive multiple sclerosis
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2017-05-19
Enrollment: 115
Sex: ALL
Minimum age (years): 18
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 preserve mobility and protect the brain in progressive forms of multiple sclerosis.

Detailed description: This two-year study will determine if daily oral intake of lipoic acid will prove superior to placebo in reducing injury to the brain and maintaining mobility in progressive MS. Mobility will be assessed with the timed 25-foot walk test and 2-minute timed walk test as well as fall counts. Neuroprotection will be measured by the extent of brain volume loss seen on MRI.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of progressive MS as defined by the study
* Able to give informed consent and to adhere to study procedures.
* Expanded Disability Status Scale (EDSS) 3.0 - 6.5: ambulatory for at least 20 meters without rest and use of bilateral aids (canes, crutches, walker) or better.

Exclusion Criteria:

* A self-reported medical or neurological problem other than MS that is a cause of progressive or fluctuating gait dysfunction
* Unable to undergo MRI
* Unable to follow directions in English as standardized scales are not all validated in other languages.
* Current major disease or disorder other than MS (e.g., cancer, renal disease, end-stage cardiopulmonary disease, post-traumatic stress disorder, etc.) that may interfere with study procedures. Note: Stable abnormal laboratory values of no more than Grade 1 determined to not be of clinical significance to the primary treating physician for that condition may be permitted per local site investigator discretion.
* Pregnant or breast-feeding.
* Insulin-dependent diabetes or diabetes not controlled on oral diabetes medications.
* Scheduled (every 3 months or more frequently) IV or oral steroids in the year prior to enrolment.
* IV or oral steroids in the 60 days prior to enrolment.
* Use of LA in the prior 2 years exceeding the equivalent of 1200mg daily for 3 months.
* Participation in the pilot LA in SPMS trial.

Primary outcomes:
measure: Change in Mobility: Timed 25 Foot Walk
timeFrame: 24 months
Secondary outcomes:
measure: Change in Mobility: 2-minute Timed Walk
timeFrame: 24 months
measure: Mobility: Fall Count
timeFrame: 24 months
measure: Brain Atrophy by MRI
timeFrame: 24 months
Other outcomes:
measure: Safety: Adverse Event Monitoring
timeFrame: 24 months
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Washington
country: United States
facility: Washington DC VA Medical Center, Washington, DC
state: District of Columbia
city: Portland
country: United States
facility: VA Portland Health Care System, Portland, OR
state: Oregon
city: Dallas
country: United States
facility: VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Salt Lake City
country: United States
facility: VA Salt Lake City Health Care System, Salt Lake City, UT
state: Utah
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
Study officials:
affiliation: VA Portland Health Care System, Portland, OR
name: Rebecca I. Spain, MD MSPH
role: PRINCIPAL_INVESTIGATOR
References: