Chronic Inflammatory Demyelinating Polyneuropathy
Conditions
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.
Interventions
DRUGH.P. Acthar® Gel
Sponsors
Mallinckrodt
Mamatha Pasnoor, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Related Adverse Events | 28 Weeks | Count of adverse events experienced by study participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Maximum Grip Strength | 28 weeks | Measured by the amount of force a person uses to squeeze around a dynamometer. |
| Manual Muscle Testing (MMT) | 28 Weeks | Measure based on the Medical Research Council (MRC) sum score (strength score combined for 12 specified muscle groups) on MMT. |
| Rasch-built Overall Disability Scale (R-ODS) | 28 Weeks | The R-ODS is a questionnaire that rates a person's ability to perform 24 daily activities such as eating, using the toilet, taking a shower, dressing, walking, dancing, running, or standing. Scores range from 0-48 with 0 meaning they cannot perform any of the tasks and 48 meaning they can perform all of the tasks without any difficulty. |
Countries
United States
Outcome results
None listed