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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01900093 |
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Date of registration:
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11/07/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of the Response to Acthar Gel Therapy in Patients Who Failed Intravenous Methylprednisolone (IVMP) for MS Relapses
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Scientific title:
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An Open-Label Prospective Proof-Of-Concept Trial to Evaluate the Response to Acthar Gel Therapy in Patients With Multiple Sclerosis (MS) Relapses Who Have Failed To Make an Adequate Recovery After Treatment With High-Dose Intravenous Methylprednisolone |
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Date of first enrolment:
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July 2013 |
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Target sample size:
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10 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT01900093 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Fred Lublin, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Icahn School of Medicine at Mount Sinai |
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Name:
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Michelle Fabian, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Icahn School of Medicine at Mount Sinai |
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Name:
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Tarah Herrmann |
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Address:
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Telephone:
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212-241-4264 |
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Email:
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tarah.gustafson@mssm.edu |
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Affiliation:
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Name:
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Sylvia Klineova, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Icahn School of Medicine at Mount Sinai |
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Name:
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Aaron Miller, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Icahn School of Medicine at Mount Sinai |
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Name:
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Gretchen Mathewson, NP |
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Address:
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Telephone:
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Email:
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Affiliation:
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Icahn School of Medicine at Mount Sinai |
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Name:
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Ilana Katz-Sand, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Icahn School of Medicine at Mount Sinai |
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Name:
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Stephen Krieger, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Icahn School of Medicine at Mount Sinai |
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Name:
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Aliza Ben-Zacharia, NP |
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Address:
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Telephone:
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Email:
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Affiliation:
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Icahn School of Medicine at Mount Sinai |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- 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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Drug: Acthar Gel
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Primary Outcome(s)
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Improvement in Functional System Score appropriate to the Targeted Neurological Deficit
[Time Frame: at one week]
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Secondary Outcome(s)
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Improvement in Expanded Disability Status Scale
[Time Frame: baseline and at 1 week]
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Secondary ID(s)
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GCO 13-0600
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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