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A Tolerability Study of ALKS 8700 in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) EVOLVE-MS-2

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: NCT03093324
Recruitment Status : Completed
First Posted : March 28, 2017
Last Update Posted : March 13, 2020
Sponsor:
Collaborator:
Alkermes, Inc.
Information provided by (Responsible Party):
Biogen

Brief Summary:
The objectives of this study are to evaluate the utility of two gastrointestinal (GI) symptom scales (Individual GI Symptom and Impact Scale {IGISIS} and Global GI Symptom and Impact Scale {GGISIS}) in assessing GI tolerability in adult subjects with RRMS after administration of ALKS 8700 or Dimethyl Fumarate (DMF) in Part A, to compare the GI tolerability of ALKS 8700 and DMF in adult subjects with RRMS using IGISIS and GGISIS in Part B, and to Evaluate the safety and tolerability of ALKS 8700 in adult subjects with RRMS in Parts A and B.

Condition or disease Intervention/treatment Phase
Relapsing Remitting Multiple Sclerosis Drug: ALKS 8700 Drug: Dimethyl Fumarate Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 506 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Study in Subjects With Relapsing Remitting Multiple Sclerosis to Evaluate the Tolerability of ALKS 8700 and Dimethyl Fumarate
Actual Study Start Date : March 15, 2017
Actual Primary Completion Date : June 27, 2019
Actual Study Completion Date : June 27, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ALKS 8700
Oral capsules, administered orally twice daily.
Drug: ALKS 8700
Administered as specified in the treatment arm.

Active Comparator: Dimethyl Fumarate
Oral capsules, administered orally twice daily.
Drug: Dimethyl Fumarate
Administered as specified in the treatment arm.
Other Name: Tecfidera




Primary Outcome Measures :
  1. Number of days with Individual Gastrointestinal Symptom and Impact Scale (IGISIS) score ≥3 relative to exposure days in Part B [ Time Frame: Up to Week 6 ]
    The IGISIS is designed to assess the incidence, intensity, onset, duration, and functional impact of 5 individual GI symptoms: nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea. This scale will be subject-completed using e-diaries. Participants will be asked to rate the severity of each individual symptom via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme).


Secondary Outcome Measures :
  1. Area under the curve (AUC) for the total IGISIS symptom intensity score relative to exposure days in Part B [ Time Frame: Up to Week 6 ]
  2. Number of days with a Global Gastrointestianl Symptom and Impact Scale (GGISIS) score ≥3 relative to exposure days in Part B [ Time Frame: Up to Week 6 ]
    The GGISIS is a global scale to assess the overall intensity, bothersomeness, and functional impact of GI symptoms experienced during the previous 24 hours. This scale will be subject-completed using e-diaries. Subjects will be asked to rate the intensity and bothersomeness of GI symptoms experienced using an 11-point numeric rating scale.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Capable of understanding and complying with the protocol
  • Has a confirmed diagnosis of RRMS
  • Neurologically stable with no evidence of relapse within 30 days prior to randomization
  • Agrees to use an acceptable method of contraception for the duration of the study and for 30 days after any study drug administration, or is surgically sterile or post-menopausal

Key Exclusion Criteria:

  • Have any finding(s) that would compromise the safety of the subject, affect the subject's ability to adhere to the protocol visit schedule or to fulfill visit requirements, or would make the subject unsuitable for participation in the study
  • Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS
  • History of clinically significant cardiovascular, pulmonary, GI, dermatologic, psychiatric, neurologic (other than MS), endocrine, renal, and/or other major disease that would preclude participation in a clinical trial
  • History of GI surgery (except appendectomy that occurred more than 6 months prior to screening
  • History of clinically significant recurring or active gastrointestinal symptoms (eg, nausea, diarrhea, dyspepsia, constipation) within 3 months of screening
  • Chronic use (7 days) of medical therapy to treat any GI symptoms within 1 month of screening Has a clinically significant medical condition or observed abnormality at screening
  • History of a myocardial infarction, including a silent myocardial infarction or unstable angina
  • History of clinically significant drug or alcohol abuse within the past year prior to screening
  • Clinically significant history of suicidal ideation or suicidal behavior in the last 12 months
  • Subject is pregnant or breastfeeding or plans to become pregnant or begin breastfeeding at any point during the study and for 30 days after any study drug administration
  • Prior use of Dimethyl Fumarate (DMF)

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.


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): NCT03093324


Locations
Show Show 67 study locations
Sponsors and Collaborators
Biogen
Alkermes, Inc.
Investigators
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Study Director: Medical Director Biogen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT03093324    
Other Study ID Numbers: ALK8700-A302
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Biogen:
RRMS
Multiple Sclerosis
MS
Alkermes
ALKS 8700
Dimethyl Fumarate
DMF
Tecfidera
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
Dimethyl Fumarate
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs