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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 : June 11, 2018
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.

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 : November 2018
Estimated Study Completion Date : November 2018

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. Expanded Disability Status Scale (EDSS) [ Time Frame: Day 42 ]
    Response rate on EDSS for each treatment group

  2. Expanded Disability Status Scale (EDSS) [ Time Frame: Day 42 ]
    90% confidence interval (CI) of response rate on EDSS for each treatment group


Secondary Outcome Measures :
  1. 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

  2. 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

  3. EDSS [ Time Frame: Days 7 and 21 ]
    Response rate on EDSS for each treatment group

  4. EDSS [ Time Frame: Days 7 and 21 ]
    90% CI of response rate on EDSS for each treatment group

  5. Clinical Global Impression of Improvement Scale (CGI-I) [ Time Frame: Days 7, 21, and 42 ]
    CGI-I mean scores for each treatment group

  6. Clinical Global Impression of Improvement Scale (CGI-I) [ Time Frame: Days 7, 21, and 42 ]
    90% CI of mean scores for each treatment group



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

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
Contact: Valerie Carvajal 800-556-3314 clinicaltrials@mnk.com

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Sponsors and Collaborators
Mallinckrodt
Investigators
Study Director: Bryan Due, PhD Mallinckrodt

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: June 11, 2018
Last Verified: June 2018

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:
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