Clinical Trial: Pilot Study of Acthar® Gel in Chronic Inflammatory Demyelinating Neuropathy

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Pilot Study of Acthar® Gel in Chronic Inflammatory Demyelinating Neuropathy

Brief Summary: The purpose of this pilot study is to assess the safety and efficacy of Acthar® Gel in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) patients.

Detailed Summary:
Sponsor: Mamatha Pasnoor, MD

Current Primary Outcome: Number of Participants With Treatment-Related Adverse Events [ Time Frame: 28 Weeks ]

Count of adverse events experienced by study participants.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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.


Original Secondary Outcome: Same as current

Information By: University of Kansas Medical Center

Dates:
Date Received: August 30, 2015
Date Started: August 2015
Date Completion: July 2018
Last Updated: July 15, 2016
Last Verified: July 2016