Lipoic Acid to Treat Chronic Inflammatory Demyelinating Polyneuropathy

Phase 2

Completed

• Conditions: Chronic Inflammatory Demyelinating Polyneuropathy; CIDP
• Interventions: Drug: lipoic acid

• Registration Number: NCT00962429
• Lead Sponsor: Oregon Health and Science University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-08-19
• Study First Submitted QC: 2009-08-19
• Study First Posted: 2009-08-20
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Results First Submitted: 2020-06-17
• Status Verified: 2020-08
• Results First Submitted QC: 2020-08-18
• Last Update Submitted: 2020-08-18
• Results First Posted: 2020-08-19
• Last Update Posted: 2020-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	lipoic acid	sugar pill
Lipoic acid	lipoic acid	alpha lipoic acid

Primary Outcome Measures

Name	Time	Method
Muscle Strength	16 weeks

Secondary Outcome Measures

Name	Time	Method
Hughes Functional Disability Scale	16 weeks
Forced Vital Capacity (FVC)	16 weeks
Motor Nerve Conduction Studies (NCS)	16 weeks

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States