Pilot Study of Acthar® Gel in Chronic Inflammatory Demyelinating Neuropathy

NCT ID: NCT02574962

Last Updated: 2016-07-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2018-07-31

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.

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

H.P. Acthar® Gel

Intervention Type: DRUG

Interventions

H.P. Acthar® Gel

Intervention Type: DRUG

Other Intervention Names

Acthar® Gel; repository corticotropin injection

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mallinckrodt

INDUSTRY

Sponsor Role: collaborator

Mamatha Pasnoor, MD

OTHER

Sponsor Role: lead

Responsible Party

Mamatha Pasnoor, MD

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mamatha Pasnoor, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

Phoenix Neurological Associates

Phoenix, Arizona, United States

University of Southern California

Los Angeles, California, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Wesley Neurology Group

Memphis, Tennessee, United States

University of Vermont

Burlington, Vermont, United States

Countries

United States

Other Identifiers

STUDY00002770

Identifier Type: -

Identifier Source: org_study_id