Lipoic Acid to Treat Chronic Inflammatory Demyelinating Polyneuropathy
Primary Purpose
CIDP, Chronic Inflammatory Demyelinating Polyneuropathy
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
lipoic acid
Sponsored by
About this trial
This is an interventional treatment trial for CIDP focused on measuring neuropathy, lipoic acid
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
Sites / Locations
- Oregon Health & Science University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Lipoic acid
Placebo
Arm Description
alpha lipoic acid
sugar pill
Outcomes
Primary Outcome Measures
Muscle Strength
Secondary Outcome Measures
Hughes Functional Disability Scale
Forced Vital Capacity (FVC)
Motor Nerve Conduction Studies (NCS)
Full Information
NCT ID
NCT00962429
First Posted
August 19, 2009
Last Updated
August 18, 2020
Sponsor
Oregon Health and Science University
Collaborators
Collins Medical Trust
1. Study Identification
Unique Protocol Identification Number
NCT00962429
Brief Title
Lipoic Acid to Treat Chronic Inflammatory Demyelinating Polyneuropathy
Official Title
Lipoic Acid for Chronic Inflammatory Demyelinating Polyneuropathy-A Randomized, Double-Blind, Placebo Controlled Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon Health and Science University
Collaborators
Collins Medical Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CIDP, Chronic Inflammatory Demyelinating Polyneuropathy
Keywords
neuropathy, lipoic acid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lipoic acid
Arm Type
Active Comparator
Arm Description
alpha lipoic acid
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
sugar pill
Intervention Type
Drug
Intervention Name(s)
lipoic acid
Other Intervention Name(s)
LA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Muscle Strength
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Hughes Functional Disability Scale
Time Frame
16 weeks
Title
Forced Vital Capacity (FVC)
Time Frame
16 weeks
Title
Motor Nerve Conduction Studies (NCS)
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jau-Shin Lou, MD, PhD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Lipoic Acid to Treat Chronic Inflammatory Demyelinating Polyneuropathy
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