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

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ClinicalTrials.gov Identifier: NCT03126760
Recruitment Status : Recruiting
First Posted : April 24, 2017
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Relapsing, Remitting Multiple Sclerosis Drug: Repository Corticotropin Injection Drug: Placebo Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 22, 2017
Estimated Primary Completion Date : February 27, 2020
Estimated Study Completion Date : October 5, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Acthar
Repository Corticotropin Injection 1 mL (80U) subcutaneously administered QD for 14 consecutive days
Drug: Repository Corticotropin Injection
Administered subcutaneously once a day for 14 consecutive days
Other Name: H.P. Acthar® Gel

Placebo Comparator: Placebo
Placebo 1 mL subcutaneously administered QD for 14 consecutive days.
Drug: Placebo
Administered subcutaneously once a day for 14 consecutive days




Primary Outcome Measures :
  1. Response rate on Expanded Disability Status Scale (EDSS) at Day 42 [ Time Frame: Day 42 ]
    The EDSS is a 10 step assessment of neurological impairment/disability in MS ranging from 0 (normal neurological examination) to 10 (death due to MS) that is completed by a blinded rater. The blinded rater will not be involved in any aspects of participant care and management other than performing the EDSS/FSS evaluations in participant in the study.

  2. Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Day 42 ]
    Data for AE and SAE will be presented.

  3. Change from Baseline in diastolic/systolic blood pressures [ Time Frame: Baseline and Up to Day 42 ]
    Data will be summarized for each visit.

  4. Change from Baseline in respiratory rate [ Time Frame: Baseline and Up to Day 42 ]
  5. Change from Baseline in heart rate [ Time Frame: Baseline and Up to Day 42 ]
  6. Change from Baseline in body temperature [ Time Frame: Baseline and Up to Day 42 ]
  7. Change from Baseline in Clinically Significant Laboratory Test Abnormalities - Hematology [ Time Frame: Baseline and Up to Day 42 ]
  8. Change from Baseline in Clinically Significant Laboratory Test Abnormalities - blood chemistry [ Time Frame: Baseline and Up to Day 42 ]
  9. Change from Baseline in Clinically Significant Laboratory Test Abnormalities -urinalysis [ Time Frame: Baseline and Up to Day 42 ]

Secondary Outcome Measures :
  1. The response rates on Multiple Sclerosis Impact Scale Version 1 (MSIS-29) and 90% confidence intervals (CIs) [ Time Frame: Days 7, 14, 21 and 42 ]
    The MSIS-29 measures the physical (20 items) and psychological (9 items) impact of MS from the participant's perspective. This validated questionnaire will result in a total score between 29 and 145 and can provide separate scores for physical and psychological impact. The MSIS-29 will be completed by the participant at all required times points during the study except on Study Day 14 when the MSIS-29 will be administered via telephone by a call center trained in the administration of the MSIS-29 or captured via a web portal.

  2. The response rates on EDSS and 90% CIs on Day 7 and Day 21 [ Time Frame: Days 7 and 21 ]
    The EDSS is a 10 step assessment of neurological impairment/disability in MS ranging from 0 (normal neurological examination) to 10 (death due to MS) that is completed by a blinded rater. The blinded rater will not be involved in any aspects of participant care and management other than performing the EDSS/FSS evaluations in participant in the study.

  3. Clinical Global Impression of Improvement Scale (CGI-I) mean scores and 90% CIs [ Time Frame: Days 7, 21 and 42 ]
    The CGI-I was developed for use in clinical research to provide a brief overview of the change in a participant's global function compared to baseline and regardless of study drug treatment. It requires a rating from 1 (very much improved) to 7 (very much worse).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03126760


Contacts
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Contact: Study Manager 800-556-3314 clinicaltrials@mnk.com

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Locations
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United States, Arizona
Territory Neurology and Research Institute Withdrawn
Tucson, Arizona, United States, 85704
United States, California
Stanford University Medical Center Recruiting
Palo Alto, California, United States, 94304
United States, Colorado
Advanced Neurosciences Research LLC Recruiting
Fort Collins, Colorado, United States, 80528
United States, Florida
University of South Florida Recruiting
Bradenton, Florida, United States, 34205
Neurology Associates, P. A. Recruiting
Maitland, Florida, United States, 32751
University of Miami - Miller School of Medicine Recruiting
Miami, Florida, United States, 33136
Tallahassee Neurological Clinic, PA Recruiting
Tallahassee, Florida, United States, 32308
United States, Georgia
Multiple Sclerosis Center of Atlanta Recruiting
Atlanta, Georgia, United States, 30327
Meridian Clinical Research LLC Recruiting
Savannah, Georgia, United States, 31405
United States, Illinois
Consultants in Neurology LTD Recruiting
Northbrook, Illinois, United States, 60062
OSF Healthcare System Saint Francis Medical Center Recruiting
Peoria, Illinois, United States, 61603
United States, Indiana
Fort Wayne Neurological Center Recruiting
Fort Wayne, Indiana, United States, 46804
Indiana University School of Medicine Recruiting
Indianapolis, Indiana, United States, 46202
United States, Kansas
University of Kansas Medical Center Research Institute, Inc. Recruiting
Kansas City, Kansas, United States, 66160
United States, Michigan
Wayne State University (WSU) - Multiple Sclerosis Treatment and Clinical Research Center (MS Center) Recruiting
Detroit, Michigan, United States, 97205
United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87131
United States, New York
University of Buffalo Recruiting
Buffalo, New York, United States, 14215
NYU Langone Multiple Sclerosis Comprehensive Care Center Withdrawn
New York, New York, United States, 10016
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
United States, North Carolina
Wake Forest University School of Medicine Recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
The Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
University of Cincinnati Physicians Company, LLC Recruiting
Dayton, Ohio, United States, 45417
Northern Ohio Neuroscience, LLC Recruiting
Sandusky, Ohio, United States, 44870
United States, Texas
Texas Neurology, PA Recruiting
Dallas, Texas, United States, 75214
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Central Texas Neurology Consultants Withdrawn
Round Rock, Texas, United States, 78681
Neurology Center of San Antonio Recruiting
San Antonio, Texas, United States, 78258
United States, Utah
Rocky Mountain MS Research Group Recruiting
Salt Lake City, Utah, United States, 84103
United States, Virginia
VCU Medical Center Recruiting
Richmond, Virginia, United States, 23298
United States, Washington
MultiCare Neuroscience Center of WA Recruiting
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Mallinckrodt
Investigators
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Study Director: Study Director, PhD Mallinckrodt

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Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT03126760     History of Changes
Other Study ID Numbers: MNK14274069
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Adrenocorticotropic Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs