Pilot Study of Acthar® Gel in Chronic Inflammatory Demyelinating Neuropathy

• Sponsor: Mamatha Pasnoor, MD (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT02574962
• Collaborator: Mallinckrodt (Industry)
• Enrollment: 0
• Locations: 5
• Arm: 1
• Duration (Months): 35
• Patients Per Site: 0
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Inflammatory Demyelinating Polyneuropathy	Drug: H.P. Acthar® Gel	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pilot Study of Acthar® Gel in Chronic Inflammatory Demyelinating Neuropathy
• Study Start Date: Aug 1, 2015
• Anticipated Primary Completion Date: Jul 1, 2018
• Anticipated Study Completion Date: Jul 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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; Other Names: Acthar® Gel repository corticotropin injection

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Treatment-Related Adverse Events [28 Weeks]

   Count of adverse events experienced by study participants.

Secondary Outcome Measures

1. Efficacy of study drug [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.

Other Outcome Measures

1. Maximum Grip Strength [28 weeks]

   Measured by the amount of force a person uses to squeeze around a dynamometer.

2. Manual Muscle Testing (MMT) [28 Weeks]

   Measure based on the Medical Research Council (MRC) sum score (strength score combined for 12 specified muscle groups) on MMT.

3. Rasch-built Overall Disability Scale (R-ODS) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Phoenix Neurological Associates	Phoenix	Arizona	United States	85018
2	University of Southern California	Los Angeles	California	United States	90033
3	University of Kansas Medical Center	Kansas City	Kansas	United States	66160
4	Wesley Neurology Group	Memphis	Tennessee	United States	38163
5	University of Vermont	Burlington	Vermont	United States	05405

Sponsors and Collaborators

• Mamatha Pasnoor, MD
• Mallinckrodt

Investigators

• Principal Investigator: Mamatha Pasnoor, MD, University of Kansas Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mamatha Pasnoor, MD, Associate Professor, University of Kansas Medical Center
• ClinicalTrials.gov Identifier: NCT02574962
• Other Study ID Numbers: STUDY00002770
• First Posted: Oct 14, 2015
• Last Update Posted: Jul 18, 2016
• Last Verified: Jul 1, 2016

• Additional relevant MeSH terms: Polyneuropathies; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; Adrenocorticotropic Hormone

Study Results

No Results Posted as of Jul 18, 2016