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Completed

NCT Number: NCT00962429

Lipoic Acid to Treat Chronic Inflammatory Demyelinating Polyneuropathy

The purpose of the study is to examine if alpha lipoic acid is an effective treatment for chronic inflammatory demyelinating polyneuropathy (CIDP).

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Key information

About this study

Chronic inflammatory demyelinating polyneuropathy (CIDP) is a progressive disease leading to paralysis. CIDP is an immune-mediated disorder resulting from a synergistic interaction of T cell-mediated and B cell-mediated immune responses directed against peripheral nerve antigens. These immune mediated responses in turn increase the production of reactive oxygen intermediate and cause oxidative damage of the peripheral nerve system. Although corticosteroids, plasma exchange, and intravenous immunoglobulin (IVIg) reduce impairment caused by CIDP at least temporarily and can be used as a first-line treatments, they are not ideal for long-term treatment because of serious side effects and cost. Alpha lipoic acid (LA) is an antioxidant that also possesses anti-immune activity. It is effective in treating diabetic neuropathy. It is also promising in treating patients with multiple sclerosis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosis of CIDP
  • on a stable dose of immunotherapy for at least 3 months before enrolling in the study

Exclusion criteria

  • myelopathy or evidence of central demyelination
  • persistent neurological deficits from stroke, CNS trauma, or peripheral neuropathy from other causes (eg, diabetes mellitus, IgM, paraproteinaemia, or uraemic, toxic, or familial neuropathy)
  • evidence of systemic disease that might cause neuropathy
  • heart diseases (congestive heart failure or arrhythmia)
  • pulmonary conditions (asthma or CIPD)
  • rheumatoid conditions (such as rheumatoid arthritis)
  • renal failure

Treatment and study plan

lipoic acid

Drug

Subjects will be started on a single daily dose of 600 mg of alpha lipoic acid or placebo for the first 4 weeks and then increased to 1200 mg for the remainder of the study.

Other names: LA

Primary outcomes

  1. Muscle Strength

    Time frame: 16 weeks

Secondary outcomes

  1. Hughes Functional Disability Scale

    Time frame: 16 weeks

  2. Forced Vital Capacity (FVC)

    Time frame: 16 weeks

  3. Motor Nerve Conduction Studies (NCS)

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Collins Medical Trust

Registry information

Official study title

Lipoic Acid for Chronic Inflammatory Demyelinating Polyneuropathy-A Randomized, Double-Blind, Placebo Controlled Pilot Study

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Aug 20, 2009
Registry last updated
Aug 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.