Pilot Study of Acthar® Gel in Chronic Inflammatory Demyelinating Neuropathy



Status:Not yet recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:August 2015
End Date:July 2018
Contact:Laura Herbelin
Email:LHERBELIN@kumc.edu
Phone:(913) 588-5095

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The purpose of this pilot study is to assess the safety and efficacy of Acthar® Gel in
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) patients.


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.
We found this trial at
5
sites
Los Angeles, California 90033
213) 740-2311
Principal Investigator: Said R Beydoun, MD
Phone: 323-442-6221
University of Southern California The University of Southern California is one of the world’s leading...
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85 S Prospect St
Burlington, Vermont 5405
(802) 656-3131
Principal Investigator: Rup Tandan, MD
University of Vermont The University of Vermont combines faculty-student relationships most commonly found in a...
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5090 N 40th St # 250
Phoenix, Arizona 85018
Principal Investigator: David Saperstein, MD
Phone: 602-358-2271
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Phone: 913-588-5095
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Memphis, Tennessee 38163
Principal Investigator: Tulio Bertorini, MD
Phone: 901-725-8920
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Memphis, TN
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