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| Name | Class |
|---|---|
| Mallinckrodt | INDUSTRY |
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The purpose of this pilot study is to assess the safety and efficacy of Acthar® Gel in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acthar® Gel | Experimental | For the first two weeks participants will receive 1 mL of study drug subcutaneously every other day. After that, participants will received 1 mL of study drug twice a week for up to 6 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| H.P. Acthar® Gel | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Related Adverse Events | Count of adverse events experienced by study participants. | 28 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of study drug | Measured using the Inflammatory Neuropathy Cause and Treatment (INCAT) score. The INCAT scale has upper and lower extremity components (maximum of 5 points for upper (arm disability) and maximum of 5 points for lower (leg disability) that add up to a maximum of 10-points. A score of 0 indicates no problems. A score of 10 indicates person is severely incapacitated. | Change from Baseline to 28 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Grip Strength | Measured by the amount of force a person uses to squeeze around a dynamometer. | 28 weeks |
| Manual Muscle Testing (MMT) | Measure based on the Medical Research Council (MRC) sum score (strength score combined for 12 specified muscle groups) on MMT. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mamatha Pasnoor, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Neurological Associates | Phoenix | Arizona | 85018 | United States | ||
| University of Southern California |
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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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| 28 Weeks |
| Rasch-built Overall Disability Scale (R-ODS) | The R-ODS is a questionnaire that rates a person's ability to perform 24 daily activities such as eating, using the toilet, taking a shower, dressing, walking, dancing, running, or standing. Scores range from 0-48 with 0 meaning they cannot perform any of the tasks and 48 meaning they can perform all of the tasks without any difficulty. | 28 Weeks |
| Los Angeles |
| California |
| 90033 |
| United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Wesley Neurology Group | Memphis | Tennessee | 38163 | United States |
| University of Vermont | Burlington | Vermont | 05405 | United States |
| 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 |