Lipoic Acid to Treat Chronic Inflammatory Demyelinating Polyneuropathy

Oregon Health & Science University (OHSU)

Status and phase: Completed; Phase 2

Conditions: Chronic Inflammatory Demyelinating Polyneuropathy; CIDP

Treatments: Drug: lipoic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT00962429

CMT-Lou

Details and patient eligibility

About

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

Full description

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.

Enrollment: 7 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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7 participants in 2 patient groups, including a placebo group

Lipoic acid

Active Comparator group

Description:

alpha lipoic acid

Treatment:

Drug: lipoic acid

Placebo

Placebo Comparator group

Description:

sugar pill

Treatment:

Drug: lipoic acid