Pilot Study of Acthar® Gel in Chronic Inflammatory Demyelinating Neuropathy

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Study of Acthar® Gel in Chronic Inflammatory Demyelinating Neuropathy

Conditions
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Chronic Inflammatory Demyelinating Polyneuropathy

Intervention / Treatment
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* Drug: H.P. Acthar® Gel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acthar® Gel<br>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<br> <br> * Other names: repository corticotropin injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment-Related Adverse Events | Count of adverse events experienced by study participants. | 28 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from Baseline to 28 Weeks |