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Corticosteroid
Acthar® Gel for Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Phase 2
Waitlist Available
Research Sponsored by Mamatha Pasnoor, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 weeks
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
Summary
The purpose of this pilot study is to assess the safety and efficacy of Acthar® Gel in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) patients.
Eligible Conditions
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants With Treatment-Related Adverse Events
Secondary study objectives
Efficacy of study drug
Other study objectives
Manual Muscle Testing (MMT)
Maximum Grip Strength
Rasch-built Overall Disability Scale (R-ODS)
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Acthar® GelExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Mamatha Pasnoor, MDLead Sponsor
MallinckrodtIndustry Sponsor
201 Previous Clinical Trials
15,866 Total Patients Enrolled
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