Clinical Trial Details

Overview

Research Study Summary

A Multicenter, Randomized, Double Blind, Placebo Controlled Parallel Group, Pilot Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in Subjects With Relapsing-remitting Multiple Sclerosis

Purpose

Subjects with RRMS who have experienced a relapse and who will receive 3 to 5 (given over a period of up to 7 days) days of treatment with high dose steroids (oral or IV) within 10 days of the onset of relapse symptoms are candidates for the current study. At 14 (± 1) days following the initiation of high dose steroids, subjects will be re-assessed with the Expanded Disability Status Scale/Functional Systems Score (EDSS/FSS) and subjects who do not improve by at least 1 point on the FSS will be randomized on a 1:1 basis to receive subcutaneous (SC) Acthar 1 mL (80 U) once a day (QD) or SC matching placebo 1 mL QD for 14 days. Follow-up visits then occur at 14, 28 and 42 days.

To Learn more

CW ID: 225779
Date Last Changed: July 28, 2017

Clinical Trial Snapshot

Phase
4
Gender
Both Male and Female
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Mallinckrodt
Facility Type
N/A

Eligibility

Inclusion Criteria:
  1. Subjects must have a diagnosis of relapsing-remitting multiple sclerosis (RRMS) according to the revised McDonald criteria.
  2. Subjects must have had a relapse with onset ≤ 25 days prior to the Baseline Visit. Relapse is defined as new neurological symptom(s) persisting for ≥ 24 hours, and accompanied by an objective change in neurological examination.
  3. Subject must have started treatment with 3 to 5 days of high dose corticosteroids within 10 days of the onset of the first relapse symptom.
  4. Subjects must have an EDSS score of 3.5 to 6.5 (inclusive) at the Baseline Visit.
Exclusion Criteria:
  1. Subject has a history of use of Acthar for the treatment of multiple sclerosis (MS).
  2. Subject has only sensory, bowel/bladder, and/or cognitive symptoms of MS associated with the most recent relapse.
  3. Subject has a history of sensitivity to adrenocorticotropic hormone (ACTH) preparations or to porcine protein products.
  4. Subject has been treated with natalizumab, alemtuzumab, ocrelizumab, daclizumab or any immunosuppressants (including but not limited to cyclophosphamide, mitoxantrone, or rituximab) in the 6 months prior to the Screening Visit or throughout the study.
  5. Subjects receiving any disease modifying treatments (including beta-interferons, glatiramer acetate, fingolimod, teriflunomide, and dimethyl fumarate) must have been on a stable dose(s) for 30 days prior to the Baseline Visit, and plan to remain on that dose(s) throughout the study.

More Info

MNK14274069

Contact

Angela Aungst
University of South Florida-Morsani College of Medicine
13330 USF Laurel Drive
Tampa, FL 33612
Phone: (813) 974-6378

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