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Lipoic Acid for Progressive Multiple Sclerosis (MS)
Lipoic Acid for Progressive Multiple Sclerosis (MS)

NCT03161028

CompletedPhase 2

Sponsor: VA Office of Research and Development

Conditions: Multiple Sclerosis

Interventions: Lipoic acid, Placebo

Countries: United States, Canada

The purpose of the study is to determine if lipoic acid can preserve mobility and protect the brain in progressive forms of multiple sclerosis.

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (11)
  • Birmingham, Alabama, United States
  • Aurora, Colorado, United States
  • Washington D.C., District of Columbia, United States
  • Portland, Oregon, United States
  • Dallas, Texas, United States
  • Salt Lake City, Utah, United States
  • Salt Lake City, Utah, United States
  • Burlington, Vermont, United States
  • Seattle, Washington, United States
  • Seattle, Washington, United States
  • Ottawa, Ontario, Canada