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

Recruiting in Palo Alto (17 mi)

Overseen by Aliza Ben-Zacharia, NP

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Aaron Miller

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Michelle Fabian, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Gretchen Mathewson, NP

Principal Investigator

Icahn School of Medicine at Mount Sinai

Sylvia Klineova, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Fred Lublin, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Stephen Krieger, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Ilana Katz-Sand, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Aaron Miller, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Aliza Ben-Zacharia, NP

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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.

Treatment Details

Interventions

• Acthar Gel (Corticosteroid)

Participant Groups

Group I: Acthar Gel Experimental Treatment 1 Intervention

80 units of subcutaneous Acthar Gel therapy daily

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Icahn School of Medicine at Mount Sinai New York, NY

Who Is Running the Clinical Trial?

Aaron Miller

Lead Sponsor

Trials

1

Patients Recruited

10+

Mallinckrodt

Industry Sponsor

Trials

202

Patients Recruited

15,700+