Pilot Study of Acthar® Gel in Chronic Inflammatory Demyelinating Neuropathy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02574962|
Recruitment Status : Withdrawn
First Posted : October 14, 2015
Last Update Posted : July 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Chronic Inflammatory Demyelinating Polyneuropathy||Drug: H.P. Acthar® Gel||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Acthar® Gel in Chronic Inflammatory Demyelinating Neuropathy|
|Study Start Date :||August 2015|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2018|
Experimental: Acthar® Gel
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.
Drug: H.P. Acthar® Gel
- Number of Participants With Treatment-Related Adverse Events [ Time Frame: 28 Weeks ]Count of adverse events experienced by study participants.
- Efficacy of study drug [ Time Frame: Change from Baseline to 28 Weeks ]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.
- Maximum Grip Strength [ Time Frame: 28 weeks ]Measured by the amount of force a person uses to squeeze around a dynamometer.
- Manual Muscle Testing (MMT) [ Time Frame: 28 Weeks ]Measure based on the Medical Research Council (MRC) sum score (strength score combined for 12 specified muscle groups) on MMT.
- Rasch-built Overall Disability Scale (R-ODS) [ Time Frame: 28 Weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02574962
|United States, Arizona|
|Phoenix Neurological Associates|
|Phoenix, Arizona, United States, 85018|
|United States, California|
|University of Southern California|
|Los Angeles, California, United States, 90033|
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|United States, Tennessee|
|Wesley Neurology Group|
|Memphis, Tennessee, United States, 38163|
|United States, Vermont|
|University of Vermont|
|Burlington, Vermont, United States, 05405|
|Principal Investigator:||Mamatha Pasnoor, MD||University of Kansas Medical Center|