Clinical trial NCT02574962: 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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Chronic Inflammatory Demyelinating Polyneuropathy
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Mallinckrodt
First posted: 2015-10-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Participants With Treatment-Related Adverse Events
timeFrame: 28 Weeks
Secondary outcomes:
measure: Efficacy of study drug
timeFrame: Change from Baseline to 28 Weeks
Other outcomes:
measure: Maximum Grip Strength
timeFrame: 28 weeks
measure: Manual Muscle Testing (MMT)
timeFrame: 28 Weeks
measure: Rasch-built Overall Disability Scale (R-ODS)
timeFrame: 28 Weeks
Locations:
city: Phoenix
country: United States
facility: Phoenix Neurological Associates
state: Arizona
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Memphis
country: United States
facility: Wesley Neurology Group
state: Tennessee
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
affiliation: University of Kansas Medical Center
name: Mamatha Pasnoor, MD
role: PRINCIPAL_INVESTIGATOR
References: