Pilot Study to Assess the Efficacy & Safety of H.P. Acthar® Gel in Subjects With Relapsing-remitting Multiple Sclerosis



Status:Recruiting
Conditions:Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:3/8/2019
Start Date:May 22, 2017
End Date:October 5, 2020
Contact:Study Manager
Email:clinicaltrials@mnk.com
Phone:800-556-3314

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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

This is a multicenter, multiple dose study to estimate the response rate, and examine the
safety of H.P. Acthar® Gel (Acthar) in subjects with RRMS who have not responded to high dose
steroids. Approximately 66 subjects will be randomized.

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 14 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.

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 14 days of the onset of the first relapse symptom.

4. Subjects must have an EDSS score of 2.0 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, 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.
Subjects treated with natalizumab will be excluded if they are not currently negative
for JC virus based on a negative John Cunningham (JC) virus test result in the 6
months prior to the Screening Visit.

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.
We found this trial at
30
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Fort Wayne, Indiana 46805
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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1601 Northwest 12th Avenue
Miami, Florida 33136
(305) 243-6545
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
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Albuquerque, New Mexico 87131
(505) 277-0111
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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Atlanta, GA
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Bradenton, Florida 34205
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Buffalo, New York 14215
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Dallas, Texas 75214
Phone: 214-827-3610
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1435 Cincinnati Street
Dayton, Ohio 45417
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Detroit, MI
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Fort Collins, Colorado 80528
Phone: 970-226-6111
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340 W 10th St #6200
Indianapolis, Indiana 46202
(317) 274-3772
Indiana University School of Medicine With more than 2,000 students in 2013, the Indiana University...
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Kansas City, KS
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Maitland, Florida 32751
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240 East 38th Street
New York, New York 10016
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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Northbrook, Illinois 60062
Phone: 847-373-1944
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Palo Alto, California 94304
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Peoria, IL
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Richmond, Virginia 23298
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Round Rock, Texas 78681
Phone: 512-218-1222
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Salt Lake City, Utah 84103
Phone: 801-408-5700
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San Antonio, Texas 78258
Phone: 210-490-0016
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Sandusky, Ohio 44870
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Savannah, Georgia 31406
Phone: 912-354-7676
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915 6th Avenue
Tacoma, Washington 98405
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Tallahassee, Florida 32308
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Winston-Salem, North Carolina 26157
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