Phase 4 Study of Effect of Aspirin on Flushing in Dimethyl Fumarate-Treated Participants With Relapsing-Remitting Multiple Sclerosis
Condition: Relapsing-Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis; Flushing
Intervention: dimethyl fumarate; acetylsalicylic acid; ASA-Placebo
Intervention description: enteric-coated capsule; matched placebo
Intervention MeSH terms: Aspirin; Dimethyl Fumarate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 241.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: multiple sclerosis; flushing; aspirin

Summary:

      The primary objective of the study is to evaluate whether 150 mg enteric-coated aspirin
      (acetylsalicylic acid [ASA]) taken twice a day (BID) with dimethyl fumarate (DMF)
      administration or 75 mg enteric-coated ASA taken once daily in the morning (QAM) with DMF
      administration reduces the incidence and/or severity of flushing events in subjects with
      relapsing-remitting multiple sclerosis (RRMS) compared with ASA-placebo administered with DMF
      in the clinical practice setting.

      Secondary objectives of this study are: to evaluate the safety and tolerability of DMF
      administered with and without enteric-coated ASA in the clinical practice setting; to
      evaluate the impact of DMF administration on quality of life as measured by the Short Form 36
      (SF-36®) and European Quality of Life - 5 Dimensions - 5 Levels (EQ-5D-5L) questionnaires.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Naïve to fumaric acid esters (e.g. DMF, Fumaderm, compounded fumarates)

          -  Diagnosed with RRMS and satisfies the approved therapeutic indication for DMF

          -  Participants of childbearing potential must practice effective contraception and be
             willing and able to continue contraception throughout the study

          -  Ability to complete the tolerability scales accurately using the electronic diary
             (eDiary) and ability to complete the paper Flushing Diaries

        Key Exclusion Criteria:

          -  Inability or unwillingness to comply with study requirements or, at the discretion of
             the Investigator, is deemed unsuitable for study participation

          -  One or more major comorbidities that, in the opinion of the Investigator, may affect
             the outcome of the study or otherwise makes the subject an unsuitable candidate for
             study participation. The prevailing product labels for both DMF and ASA should be used
             as guides

          -  Known active malignancies (subjects with cutaneous basal cell carcinoma that has been
             completely excised prior to study entry remain eligible)

          -  Chronic use (≥7 consecutive days) of ASA- or nonsteroidal anti-inflammatory drugs
             (NSAID)-containing products within the month prior to enrollment in the study

          -  A known intolerance to ASA

          -  Active peptic ulceration or a history of peptic ulceration, hemophilia or other
             clotting disorders, or gout

          -  Known hypersensitivity reactions (e.g., bronchospasm, rhinitis, urticaria) in response
             to ASA or NSAID administration

          -  Impaired hepatic or renal function, in the opinion of the investigator

          -  Female subject is pregnant, lactating, or will be attempting to become pregnant during
             the Double-Blind Period (first 12 weeks) of the study

          -  Currently participating in another interventional clinical trial

        NOTE: Other protocol-defined inclusion/exclusion criteria may apply