A Tolerability Study of ALKS 8700 in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) EVOLVE-MS-2
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: ALKS 8700; Dimethyl Fumarate
Intervention description: Administered as specified in the treatment arm.; Administered as specified in the treatment arm.
Intervention MeSH terms: Dimethyl Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 506.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: RRMS; Multiple Sclerosis; MS; Alkermes; ALKS 8700; Dimethyl Fumarate; DMF; Tecfidera

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.
    

Eligibility 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.