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Trial #NCT01900093
Multiple Sclerosis Clinical Trials

Evaluation of the Response to Acthar Gel Therapy in Patients Who Failed Intravenous Methylprednisolone (IVMP) for MS Relapses


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
Study ID: GCO 13-0600; Source: Mount Sinai School of Medicine
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Definitions
Interventional trials
Determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments.
Observational trials
Address health issues in large groups of people or populations in natural settings.
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Participants are currently being recruited and enrolled.
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Study is ongoing (i.e., patients are being treated or examined), but enrollment has completed.
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Participants are not yet being recruited or enrolled.
Enrolling by invitation
Participants are being (or will be) selected from a predetermined population.
Completed
The study has concluded normally; participants are no longer being examined or treated (i.e., last patient's last visit has occurred).
Withdrawn
Study halted prematurely, prior to enrollment of first participant.
Suspended
Recruiting or enrolling participants has halted prematurely but potentially will resume.
Terminated
Recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated.
Status Recruiting
Country United States
Study type Interventional
Enrollment 10
Start date July 2013
Completion date August 2014
Phase N/A
Sponsor Mount Sinai School of Medicine
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 ACTHAR gel therapy in patients who have failed to make a
satisfactory recovery after treatment with high dose IVMP. Documentation of the clinical
course as well as any adverse events related to IVMP use will be made. The investigators
propose to study the potential benefit of a 14-day course (the dose historically used since
the landmark clinical trial of Rose et al1) of subcutaneous ACTHAR gel in 10 patients who
have demonstrated inadequate improvement after a course of IVMP, 1000 mg daily, for 5
treatments (over a maximum of 8 days). These would be patients for whom PLEX would be
considered as a treatment possibility. The primary outcome measure will be improvement in
the targeted neurological deficit, as measured on the appropriate functional system score
(FSS) of the EDSS.
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 have failed to make a satisfactory recovery after treatment with high dose
methylprednisolone. Eligible patients will be given 80 units of Acthar for 14 days. Patients
will be evaluated at baseline, at 1 week of Acthar treatment, at completion of Acthar
treatment, and 1 week after completion of treatment. For those who do not undergo
plasmapheresis an additional evaluation will be conducted 2 weeks after completion of
treatment. Monitoring will include blood pressure determination and blood sugar
determination.
Eligibility:
Gender: Both
Age: 18 Years - 65 Years
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
Outcome:
Primary outcome
  • Improvement in Functional System Score appropriate to the Targeted Neurological Deficit
    Primary outcome measure will be the percentage of patients improving by at least 1 step on the FSS appropriate to their neurological deficit (targeted neurological deficit [TND]} at 1 week following completion of treatment
    Time frame: at one week
Secondary outcome
  • Improvement in Expanded Disability Status Scale
    Secondary outcome measures will be improvement in TND at completion of ACTHAR Gel therapy, improvement by at least 1 step on EDSS at completion of treatment and at 1 week following completion of treatment.
    Time frame: baseline and at 1 week
Contacts:
  • Aaron Miller, MD; Mount Sinai School of Medicine (Principal Investigator)
  • Aliza Ben-Zacharia, NP; Mount Sinai School of Medicine (Principal Investigator)
  • Fred Lublin, MD; Mount Sinai School of Medicine (Principal Investigator)
  • Gretchen Mathewson, NP; Mount Sinai School of Medicine (Principal Investigator)
  • Ilana Katz-Sand, MD; Mount Sinai School of Medicine (Principal Investigator)
  • Michelle Fabian, MD; Mount Sinai School of Medicine (Principal Investigator)
  • Stephen Krieger, MD; Mount Sinai School of Medicine (Principal Investigator)
  • Sylvia Klineova, MD; Mount Sinai School of Medicine (Principal Investigator)
  • Colleen Farrell, MA, CCRC;
    Phone: 212-241-3048
Location Country Status
Icahn School of Medicine at Mount Sinai New York, New York United States Recruiting
Sponsors:
  • Aaron Miller - (Lead Sponsor)
  • Questcor Pharmaceuticals, Inc. - Collaborator

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