Pilot Study of Acthar® Gel in Chronic Inflammatory Demyelinating Neuropathy

• Register: ClinicalTrials.gov
• Last refreshed on: 8 August 2016
• Main ID: NCT02574962
• Date of registration: 30/08/2015
• Prospective Registration: No
• Primary sponsor: Mamatha Pasnoor, MD
• Public title: Pilot Study of Acthar® Gel in Chronic Inflammatory Demyelinating Neuropathy
• Scientific title: Pilot Study of Acthar® Gel in Chronic Inflammatory Demyelinating Neuropathy
• Date of first enrolment: August 2015
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02574962
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Mamatha Pasnoor, MD
• Affiliation: University of Kansas Medical Center

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Inflammatory Demyelinating Polyneuropathy

Intervention(s)

Drug: H.P. Acthar® Gel

Primary Outcome(s)

Number of Participants With Treatment-Related Adverse Events [Time Frame: 28 Weeks]

Secondary Outcome(s)

Efficacy of study drug [Time Frame: Change from Baseline to 28 Weeks]

Secondary ID(s)

STUDY00002770

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Mallinckrodt