Pilot Study of Acthar® Gel in Chronic Inflammatory Demyelinating Neuropathy

NCT02574962 | Withdrawn Phase 2 DMC

• 1 other identifier: STUDY00002770
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 5

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-Related Adverse Events

  Count of adverse events experienced by study participants.

  28 Weeks

Secondary Outcomes (1)

• Efficacy of study drug

  Change from Baseline to 28 Weeks

Other Outcomes (3)

• Maximum Grip Strength

  28 weeks

• Manual Muscle Testing (MMT)

  28 Weeks

• Rasch-built Overall Disability Scale (R-ODS)

  28 Weeks

Study Arms (1)

Acthar® Gel

EXPERIMENTAL

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

Interventions

H.P. Acthar® Gel DRUG

Also known as: Acthar® Gel, repository corticotropin injection

Acthar® Gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mamatha Pasnoor, MD: lead
• Mallinckrodt: collaborator

Study Sites (5)

Phoenix Neurological Associates

Phoenix, Arizona, 85018, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Wesley Neurology Group

Memphis, Tennessee, 38163, United States

Location

University of Vermont

Burlington, Vermont, 05405, United States

Location

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mamatha Pasnoor, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 30, 2015
• First Posted: October 14, 2015
• Study Start: August 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: July 18, 2016

Record last verified: 2016-07

Locations

US (5)