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

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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 )

Tracking Information
First Submitted Date  ICMJE April 4, 2017
First Posted Date  ICMJE April 24, 2017
Results First Submitted Date  ICMJE May 10, 2021
Results First Posted Date  ICMJE June 3, 2021
Last Update Posted Date July 12, 2021
Actual Study Start Date  ICMJE May 22, 2017
Actual Primary Completion Date July 14, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2021)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 19, 2017)
  • Expanded Disability Status Scale (EDSS) [ Time Frame: Day 42 ]
    Response rate on EDSS for each treatment group
  • Expanded Disability Status Scale (EDSS) [ Time Frame: Day 42 ]
    90% confidence interval (CI) of response rate on EDSS for each treatment group
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2017)
  • Multiple Sclerosis Impact Scale Version 1 (MSIS-29) [ Time Frame: Days 7, 14, 21 and 42 ]
    Response rate on MSIS-29 for each treatment group
  • Multiple Sclerosis Impact Scale Version 1 (MSIS-29) [ Time Frame: Days 7, 14, 21 and 42 ]
    90% CI of response rate on MSIS-29 for each treatment group
  • EDSS [ Time Frame: Days 7 and 21 ]
    Response rate on EDSS for each treatment group
  • EDSS [ Time Frame: Days 7 and 21 ]
    90% CI of response rate on EDSS for each treatment group
  • Clinical Global Impression of Improvement Scale (CGI-I) [ Time Frame: Days 7, 21, and 42 ]
    CGI-I mean scores for each treatment group
  • Clinical Global Impression of Improvement Scale (CGI-I) [ Time Frame: Days 7, 21, and 42 ]
    90% CI of mean scores for each treatment group
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acthar Gel for Multiple Sclerosis That Keeps Getting Better and Worse (RRMS)
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE Multiple Sclerosis, Relapsing-Remitting
Intervention  ICMJE
  • Drug: Acthar Gel
    Acthar Gel 1 mL (80U) for subcutaneous injection
    Other Name: Repository Corticotropin Injection
  • Drug: Placebo
    Placebo for subcutaneous injection
    Other Name: Matching Placebo
Study Arms  ICMJE
  • Experimental: Acthar Gel
    Participants receive Acthar Gel under the skin once a day for 14 consecutive days
    Intervention: Drug: Acthar Gel
  • Placebo Comparator: Placebo
    Participants receive Placebo under the skin once a day for 14 consecutive days
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 14, 2020)
35
Original Estimated Enrollment  ICMJE
 (submitted: April 19, 2017)
66
Actual Study Completion Date  ICMJE July 14, 2020
Actual Primary Completion Date July 14, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03126760
Other Study ID Numbers  ICMJE MNK14274069
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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.
Responsible Party Mallinckrodt ( Mallinckrodt ARD LLC )
Study Sponsor  ICMJE Mallinckrodt ARD LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Team Leader Mallinckrodt
PRS Account Mallinckrodt
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP