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Pilot Study of Acthar® Gel in Chronic Inflammatory Demyelinating Neuropathy

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ClinicalTrials.gov Identifier: NCT02574962
Recruitment Status : Withdrawn
First Posted : October 14, 2015
Last Update Posted : July 18, 2016
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Mamatha Pasnoor, MD, University of Kansas Medical Center

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : August 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. Number of Participants With Treatment-Related Adverse Events [ Time Frame: 28 Weeks ]
    Count of adverse events experienced by study participants.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Maximum Grip Strength [ Time Frame: 28 weeks ]
    Measured by the amount of force a person uses to squeeze around a dynamometer.

  2. Manual Muscle Testing (MMT) [ Time Frame: 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) [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02574962


Locations
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United States, Arizona
Phoenix Neurological Associates
Phoenix, Arizona, United States, 85018
United States, California
University of Southern California
Los Angeles, California, United States, 90033
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Tennessee
Wesley Neurology Group
Memphis, Tennessee, United States, 38163
United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05405
Sponsors and Collaborators
Mamatha Pasnoor, MD
Mallinckrodt
Investigators
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Principal Investigator: Mamatha Pasnoor, MD University of Kansas Medical Center
More Information
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Responsible Party: Mamatha Pasnoor, MD, Associate Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02574962    
Other Study ID Numbers: STUDY00002770
First Posted: October 14, 2015    Key Record Dates
Last Update Posted: July 18, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Polyneuropathies
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Polyradiculoneuropathy
Autoimmune Diseases of the Nervous System
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Adrenocorticotropic Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs