Lipoic Acid to Treat Chronic Inflammatory Demyelinating Polyneuropathy

NCT ID: NCT00962429

Last Updated: 2020-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2013-01-31

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.

Conditions

CIDP; Chronic Inflammatory Demyelinating Polyneuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lipoic acid

alpha lipoic acid

Group Type: ACTIVE_COMPARATOR

lipoic acid

Intervention Type: DRUG

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.

Placebo

sugar pill

Group Type: PLACEBO_COMPARATOR

lipoic acid

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

LA

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Collins Medical Trust

OTHER

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jau-Shin Lou, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

Other Identifiers

CMT-Lou

Identifier Type: -

Identifier Source: org_study_id