Pilot Study of Acthar® Gel in Chronic Inflammatory Demyelinating Neuropathy
- Conditions
- Chronic Inflammatory Demyelinating Polyneuropathy
- Interventions
- Drug: H.P. Acthar® Gel
- Registration Number
- NCT02574962
- Lead Sponsor
- Mamatha Pasnoor, MD
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Acthar® Gel H.P. 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.
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment-Related Adverse Events 28 Weeks Count of adverse events experienced by study participants.
- Secondary Outcome Measures
Name Time Method Efficacy of study drug 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.
Trial Locations
- Locations (5)
University of Southern California
🇺🇸Los Angeles, California, United States
University of Vermont
🇺🇸Burlington, Vermont, United States
Wesley Neurology Group
🇺🇸Memphis, Tennessee, United States
Phoenix Neurological Associates
🇺🇸Phoenix, Arizona, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States