Status:
UNKNOWN
Evaluation of the Response to Acthar Gel Therapy in Patients Who Failed Intravenous Methylprednisolone (IVMP) for MS Relapses
Lead Sponsor:
Aaron Miller
Collaborating Sponsors:
Mallinckrodt
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Although ACTHAR gel is approved for the treatment of acute relapses, it is currently not widely used. Thus, we propose to conduct a small open-label proof-of-concept trial to evaluate the response to ...
Detailed Description
This is an open-label, small, proof-of-concept study examining the safety, tolerability, and extent of recovery of a two-week course of subcutaneous Acthar Gel therapy in patients with MS relapse who ...
Eligibility Criteria
Inclusion
- Ages 18-65
- EDSS of 2.0 - 7.5 (inclusive)
- Sustained a significant MS exacerbation affecting vision, brainstem, motor, or cerebellar function AND were initially treated with a 5 day course of IVMP within 10 days of the onset of symptoms.
- Failed to make adequate improvement and must initiate Acthar Gel therapy within two weeks (+/- 72 hours) after the first day of 5 treatments with 1000 mg IVMP, as judged by their treating neurologist.
- Must be able to comply with the requirements of the protocol as determined by the investigator.
- Ability to understand the purpose and risks of the study and provide signed and date informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
Exclusion
- Patients whose relapse consists of pure sensory or bowel/bladder symptoms
- History of ACTHAR gel use or other forms of ACTH with failure to improve or with occurrence of significant adverse experiences.
- Diagnosis of scleroderma, systemic fungal infections, ocular herpes simplex, congestive heart failure, and/or uncontrolled hypertension, and/or any clinically relevant medical disease that would put the patient at risk by participating in the study
- Persistent significant or severe infection
- Recent history of drug or alcohol abuse
- Concomitant use or prior use in the preceding 6 months of any investigational drug.
- Pregnant or nursing
- Recent surgery (up to the investigator's discretion what constitutes recent)
- History of, or the presence of, a peptic ulcer
- Known sensitivity to proteins of porcine origin
- Received a live or live attenuated vaccine in the last 30 days before baseline
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2018
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01900093
Start Date
July 1 2013
End Date
March 1 2018
Last Update
September 6 2017
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029