Pilot Study of Acthar® Gel in Chronic Inflammatory Demyelinating Neuropathy

Chronic Inflammatory Demyelinating Polyneuropathy Clinical Trial

Official title:

Pilot Study of Acthar® Gel in Chronic Inflammatory Demyelinating Neuropathy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02574962
• Other study ID #: STUDY00002770
• Status: Withdrawn
• Phase: Phase 2
• First received: August 30, 2015
• Last updated: July 15, 2016
• Start date: August 2015
• Est. completion date: July 2018

Study information

• Verified date: July 2016
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• CIDP diagnosed according to the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) criteria 2010

• Age > 18 years

• Able to give written informed consent

• Patient's signs and symptoms should not be better explained by another disease process

• Patients can be on prednisone as long as there has been no dose change for 4 weeks from baseline

• Patients can be on following drugs as long as there has been no change for 60 days from baseline visit including azathioprine, cyclosporine, cyclophosphamide, mycophenolate mofetil, intravenous immunoglobulin (IVIg) or other immunosuppressive drugs

• INCAT score greater than or equal to 2

Exclusion Criteria:

• Presence of any other causes of polyneuropathy or multifocal motor neuropathy, which in the opinion of the investigator is the major contributor to the numbness and weakness.

• Other neurologic or orthopedic condition causing weakness

• Treatment with plasma exchange (PLEX) within the last 30 days from baseline

• Participation in another trial within the last 30 days from baseline or two ½ life of the drug being studied.

• Latent tuberculosis or active infection

• Contraindication per Acthar® Gel prescribing information scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history or presence of peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, or adrenal cortical hyperfunction.

• History of prior sensitivity to Acthar® Gel or other porcine products

• Previous or present Infection with hepatitis C and hepatitis B

• Pregnancy or nursing mothers.

• Female subjects of childbearing potential either not using, or not willing to use, a medically reliable method of contraception for the entire duration of the study, or not sexually abstinent for the entire duration of the study, or not surgically sterile.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Inflammatory Demyelinating Polyneuropathy
• Polyneuropathies
• Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Intervention

Drug:
• H.P. Acthar® Gel

Locations

Country	Name	City	State
United States	University of Vermont	Burlington	Vermont
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	University of Southern California	Los Angeles	California
United States	Wesley Neurology Group	Memphis	Tennessee
United States	Phoenix Neurological Associates	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Mamatha Pasnoor, MD	Mallinckrodt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maximum Grip Strength	Measured by the amount of force a person uses to squeeze around a dynamometer.	28 weeks	No
Other	Manual Muscle Testing (MMT)	Measure based on the Medical Research Council (MRC) sum score (strength score combined for 12 specified muscle groups) on MMT.	28 Weeks	No
Other	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	No
Primary	Number of Participants With Treatment-Related Adverse Events	Count of adverse events experienced by study participants.	28 Weeks	Yes
Secondary	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	No