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Acthar Gel for Multiple Sclerosis That Keeps Getting Better and Worse (RRMS) (OPTIONS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03126760
Recruitment Status : Terminated (Recruitment difficulties and COVID-19 logistical challenges; no safety concerns)
First Posted : April 24, 2017
Results First Posted : June 3, 2021
Last Update Posted : July 12, 2021
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt ( Mallinckrodt ARD LLC )

Study Description
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Brief Summary:
This study will enroll about 66 participants who experienced a relapse of RRMS that steroids did not help. The doctor will put participants into a treatment group. Each person has an equal chance of being in either one of two groups (like flipping a coin). One group will receive a shot of study medicine (called Acthar Gel) under their skin every day for 14 days. The other group will receive a shot every day for 14 days, too, but there is no medicine in it (called placebo).

Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Relapsing-Remitting Drug: Acthar Gel Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: While Care Provider and Outcomes Assessor were also blinded, it was considered a double-blind study.
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double Blind, Placebo Controlled Parallel Group, Pilot Study to Assess the Efficacy and Safety of Acthar® in Subjects With Relapsing-remitting Multiple Sclerosis
Actual Study Start Date : May 22, 2017
Actual Primary Completion Date : July 14, 2020
Actual Study Completion Date : July 14, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Acthar Gel
Participants receive Acthar Gel under the skin once a day for 14 consecutive days
 Drug: Acthar Gel
Acthar Gel 1 mL (80U) for subcutaneous injection
Other Name: Repository Corticotropin Injection
Placebo Comparator: Placebo
Participants receive Placebo under the skin once a day for 14 consecutive days
 Drug: Placebo
Placebo for subcutaneous injection
Other Name: Matching Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Score on the Expanded Disability Status Scale (EDSS) at Baseline and Day 42 [ Time Frame: Baseline, Day 42 ]
    The EDSS is a 10-point assessment of neurological impairment/disability in multiple sclerosis (MS) patients, ranging from 0 (normal neurological examination) to 10 (death due to MS). EDSS is rated by a person who only collects outcome measures, and has no knowledge of the treatment received.


Eligibility Criteria
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Information from the National Library of Medicine

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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

Key Inclusion Criteria:

  • Had a clinical diagnosis of relapsing-remitting multiple sclerosis (RRMS)
  • Had a relapse with onset ≤42 days prior to the Baseline Visit
  • Had started treatment with 3 to 5 days (inclusive, over a period of up to 7 days) of specific high dose corticosteroids within 28 days of the onset of the first relapse symptom
  • Had failed to obtain improvement of at least 1 point in one or more functions on the Function Systems Score (FSS) 14 days following their first dose of high dose corticosteroids
  • Has an Expanded Disability Index Scale (EDSS) score of 2.0 to 6.5 (inclusive) at the Baseline Visit
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Mallinckrodt ARD LLC
Investigators
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Study Director: Clinical Team Leader Mallinckrodt
  Study Documents (Full-Text)

Documents provided by Mallinckrodt ( Mallinckrodt ARD LLC ):
Study Protocol and Statistical Analysis Plan  [PDF] August 15, 2019

More Information
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Responsible Party: Mallinckrodt ARD LLC
ClinicalTrials.gov Identifier: NCT03126760    
Other Study ID Numbers: MNK14274069
First Posted: April 24, 2017    Key Record Dates
Results First Posted: June 3, 2021
Last Update Posted: July 12, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Discussion of statistical endpoints and analysis are included in manuscripts. Summary aggregate (basic) results (including adverse events information) and the study protocol are made available on clinicaltrials.gov (NCT03126760) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at medinfo@mnk.com.

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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
Keywords provided by Mallinckrodt ( Mallinckrodt ARD LLC ):
Relapsing, Remitting Multiple Sclerosis
RRMS
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
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