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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00962429
Other study ID # CMT-Lou
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


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
See also
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Recruiting NCT02372149 - IVIg for Demyelination in Diabetes Mellitus Phase 4