Lipoic Acid to Treat Chronic Inflammatory Demyelinating Polyneuropathy

Official Title: “Lipoic Acid for Chronic Inflammatory Demyelinating Polyneuropathy—A Randomized, Double-Blind, Placebo Controlled Pilot Study”

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

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.

Intervention(s) in this Clinical Trial

• Drug: lipoic acid
  • 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Lipoic acid
  • alpha lipoic acid
• Placebo Comparator: Placebo
  • sugar pill

Primary Measures

• Muscle strength
  • Time Frame: 16 weeks
    Safety Issue?: No

Secondary Measures

• Hughes Functional Disability Scale
  • Time Frame: 16 weeks
    Safety Issue?: No
• Forced vital capacity (FVC)
  • Time Frame: 16 weeks
    Safety Issue?: No
• Motor nerve conduction studies (NCS)
  • Time Frame: 16 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Oregon Health and Science University Other

Overall Clinical Trial Officials and Contacts

Jau-Shin Lou, MD, PhD Principal Investigator Oregon Health and Science University  

Overall Contact: Diana Dimitrova, PhD 503-494-7269 dimitrov@ohsu.edu

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00962429

Study ID Number: CMT-Lou

ClinicalTrials.gov Identifier: NCT00962429

Health Authority: United States: Institutional Review Board