Lipoic Acid to Treat Chronic Inflammatory Demyelinating Polyneuropathy

Chronic Inflammatory Demyelinating Polyneuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00962429
• Other study ID #: CMT-Lou
• Status: Completed
• Phase: Phase 2
• Start date: February 2009
• Est. completion date: January 2013

Study information

• Verified date: August 2020
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Inflammatory Demyelinating Polyneuropathy
• CIDP
• Polyneuropathies
• Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Intervention

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.

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Collins Medical Trust

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle Strength		16 weeks
Secondary	Hughes Functional Disability Scale		16 weeks
Secondary	Forced Vital Capacity (FVC)		16 weeks
Secondary	Motor Nerve Conduction Studies (NCS)		16 weeks