Lipoic Acid to Treat Chronic Inflammatory Demyelinating Polyneuropathy

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

Detailed Description
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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.

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

Conditions
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CIDP, Chronic Inflammatory Demyelinating Polyneuropathy

Intervention / Treatment
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* Drug: lipoic acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lipoic acid<br>alpha lipoic acid | Drug: lipoic acid<br>* 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.<br>* Other names: LA;|
| Placebo Comparator: Placebo<br>sugar pill | Drug: lipoic acid<br>* 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.<br>* Other names: LA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle Strength |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hughes Functional Disability Scale |  | 16 weeks | 
| Forced Vital Capacity (FVC) |  | 16 weeks | 
| Motor Nerve Conduction Studies (NCS) |  | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neuropathy, lipoic acid