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Lipoic Acid to Treat Chronic Inflammatory Demyelinating Polyneuropathy

This study has been completed.
Sponsor:
Collaborator:
Collins Medical Trust
Information provided by (Responsible Party):
Jau-Shin Lou, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00962429
First received: August 19, 2009
Last updated: January 30, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition Intervention Phase
CIDP
Chronic Inflammatory Demyelinating Polyneuropathy
 Drug: lipoic acid
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Lipoic Acid for Chronic Inflammatory Demyelinating Polyneuropathy—A Randomized, Double-Blind, Placebo Controlled Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Muscle strength [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hughes Functional Disability Scale [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Forced vital capacity (FVC) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Motor nerve conduction studies (NCS) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: February 2009
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lipoic acid
alpha lipoic acid
 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.
Other Name: LA
Placebo Comparator: Placebo
sugar pill
 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.
Other Name: LA

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00962429

Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Collins Medical Trust
Investigators
Principal Investigator: Jau-Shin Lou, MD, PhD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Jau-Shin Lou, Associate Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00962429     History of Changes
Other Study ID Numbers: CMT-Lou
Study First Received: August 19, 2009
Last Updated: January 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
neuropathy, lipoic acid

Additional relevant MeSH terms:
Polyneuropathies
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Polyradiculoneuropathy
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
 Thioctic Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 19, 2013