CIDP, Chronic Inflammatory Demyelinating Polyneuropathy
Conditions
Keywords
neuropathy, lipoic acid
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.
Interventions
DRUGlipoic 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.
Sponsors
Collins Medical Trust
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Muscle Strength | 16 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Hughes Functional Disability Scale | 16 weeks |
| Forced Vital Capacity (FVC) | 16 weeks |
| Motor Nerve Conduction Studies (NCS) | 16 weeks |
Countries
United States
Participant flow
Pre-assignment details
The Responsible Party has left the institution and has indicated that they do not have the raw data. They have confirmed that, despite all efforts to locate the data by contacting study team members, efforts were unsuccessful and no data are available.
Participants by arm
| Arm | Count |
|---|---|
| Lipoic Acid alpha lipoic acid
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. | 0 |
| Placebo sugar pill
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. | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Muscle Strength
Time frame: 16 weeks
Population: The Responsible Party has left the institution and has indicated that they do not have the raw data. They have confirmed that, despite all efforts to locate the data by contacting study team members, efforts were unsuccessful and no data are available.
Secondary
Forced Vital Capacity (FVC)
Time frame: 16 weeks
Population: The Responsible Party has left the institution and has indicated that they do not have the raw data. They have confirmed that, despite all efforts to locate the data by contacting study team members, efforts were unsuccessful and no data are available.
Secondary
Hughes Functional Disability Scale
Time frame: 16 weeks
Population: The Responsible Party has left the institution and has indicated that they do not have the raw data. They have confirmed that, despite all efforts to locate the data by contacting study team members, efforts were unsuccessful and no data are available.
Secondary
Motor Nerve Conduction Studies (NCS)
Time frame: 16 weeks
Population: The Responsible Party has left the institution and has indicated that they do not have the raw data. They have confirmed that, despite all efforts to locate the data by contacting study team members, efforts were unsuccessful and no data are available.