Title

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

    Phase 2
  • Study Type

    Interventional
  • Study Participants

    7
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.
Study Started
Feb 28
2009
Primary Completion
Jan 31
2013
Study Completion
Jan 31
2013
Results Posted
Aug 19
2020
Last Update
Aug 19
2020

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.

  • Other names: LA

Lipoic acid Active Comparator

alpha lipoic acid

Placebo Placebo Comparator

sugar pill

Criteria

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

Summary

Lipoic Acid

Placebo

All Events

Event Type Organ System Event Term

Muscle Strength

Lipoic Acid

Placebo

Hughes Functional Disability Scale

Lipoic Acid

Placebo

Forced Vital Capacity (FVC)

Lipoic Acid

Placebo

Motor Nerve Conduction Studies (NCS)

Lipoic Acid

Placebo

Total

0
Participants