search
Back to results

Pilot Study of Acthar® Gel in Chronic Inflammatory Demyelinating Neuropathy

Primary Purpose

Chronic Inflammatory Demyelinating Polyneuropathy

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
H.P. Acthar® Gel
Sponsored by
Mamatha Pasnoor, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Inflammatory Demyelinating Polyneuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Phoenix Neurological Associates
  • University of Southern California
  • University of Kansas Medical Center
  • Wesley Neurology Group
  • University of Vermont

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acthar® Gel

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-Related Adverse Events
Count of adverse events experienced by study participants.

Secondary Outcome Measures

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.

Full Information

First Posted
August 30, 2015
Last Updated
July 15, 2016
Sponsor
Mamatha Pasnoor, MD
Collaborators
Mallinckrodt
search

1. Study Identification

Unique Protocol Identification Number
NCT02574962
Brief Title
Pilot Study of Acthar® Gel in Chronic Inflammatory Demyelinating Neuropathy
Official Title
Pilot Study of Acthar® Gel in Chronic Inflammatory Demyelinating Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Withdrawn
Study Start Date
August 2015 (undefined)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mamatha Pasnoor, MD
Collaborators
Mallinckrodt

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Inflammatory Demyelinating Polyneuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acthar® Gel
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
H.P. Acthar® Gel
Other Intervention Name(s)
Acthar® Gel, repository corticotropin injection
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-Related Adverse Events
Description
Count of adverse events experienced by study participants.
Time Frame
28 Weeks
Secondary Outcome Measure Information:
Title
Efficacy of study drug
Description
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.
Time Frame
Change from Baseline to 28 Weeks
Other Pre-specified Outcome Measures:
Title
Maximum Grip Strength
Description
Measured by the amount of force a person uses to squeeze around a dynamometer.
Time Frame
28 weeks
Title
Manual Muscle Testing (MMT)
Description
Measure based on the Medical Research Council (MRC) sum score (strength score combined for 12 specified muscle groups) on MMT.
Time Frame
28 Weeks
Title
Rasch-built Overall Disability Scale (R-ODS)
Description
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.
Time Frame
28 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mamatha Pasnoor, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phoenix Neurological Associates
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Wesley Neurology Group
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Pilot Study of Acthar® Gel in Chronic Inflammatory Demyelinating Neuropathy

We'll reach out to this number within 24 hrs