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| Name | Class |
|---|---|
| Collins Medical Trust | OTHER |
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The purpose of the study is to examine if alpha lipoic acid is an effective treatment for chronic inflammatory demyelinating polyneuropathy (CIDP).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lipoic acid | Active Comparator | alpha lipoic acid |
|
| Placebo | Placebo Comparator | sugar pill |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lipoic acid | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle Strength | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hughes Functional Disability Scale | 16 weeks | |
| Forced Vital Capacity (FVC) | 16 weeks | |
| Motor Nerve Conduction Studies (NCS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jau-Shin Lou, MD, PhD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Muscle Strength | 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. | Posted | 16 weeks |
|
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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The Responsible Party has left the institution and has indicated that they do not have the raw data. They've confirmed that, despite all efforts to locate the data by contacting study team members, efforts were unsuccessful and no data are available.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Diana Dimitrova | Oregon Health and Science University | 503-494-7269 | dimitrov@ohsu.edu |
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| ID | Term |
|---|---|
| D020277 | Polyradiculoneuropathy, Chronic Inflammatory Demyelinating |
| ID | Term |
|---|---|
| D011129 | Polyradiculoneuropathy |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D008063 | Thioctic Acid |
| ID | Term |
|---|---|
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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|
| 16 weeks |
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. |
| BG002 | Total | Total of all reporting groups |
|
| Age, Continuous |
| Sex: Female, Male |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. |
| Region of Enrollment | participants |
|
|
| Secondary | Hughes Functional Disability Scale | 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. | Posted | 16 weeks |
|
|
| Secondary | Forced Vital Capacity (FVC) | 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. | Posted | 16 weeks |
|
|
| Secondary | Motor Nerve Conduction Studies (NCS) | 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. | Posted | 16 weeks |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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 | 0 | 0 | 0 | 0 | 0 |
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| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003067 |
| Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D005227 | Fatty Acids |
| D008055 | Lipids |