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

NCT01900093 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2017-09-06

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Acthar Gel

80 units of subcutaneous Acthar Gel therapy daily

Sponsors & Collaborators

  • Mallinckrodt

    collaborator INDUSTRY

  • Aaron Miller

    lead OTHER

Principal Investigators

  • Aaron Miller, MD · Icahn School of Medicine at Mount Sinai

  • Fred Lublin, MD · Icahn School of Medicine at Mount Sinai

  • Stephen Krieger, MD · Icahn School of Medicine at Mount Sinai

  • Michelle Fabian, MD · Icahn School of Medicine at Mount Sinai

  • Ilana Katz-Sand, MD · Icahn School of Medicine at Mount Sinai

  • Sylvia Klineova, MD · Icahn School of Medicine at Mount Sinai

  • Gretchen Mathewson, NP · Icahn School of Medicine at Mount Sinai

  • Aliza Ben-Zacharia, NP · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2018-03-31
Completion
2018-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01900093 on ClinicalTrials.gov