Relapsing-Remitting Multiple Sclerosis MedDRA version: 16.1 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders MedDRA version: 16.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
Biogen Idec Research Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible to participate in this study, candidates must meet the following eligibility criteria at the Screening/Baseline Visit or at the time point specified in the individual eligibility criterion listed: 1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent in accordance with national and local subject privacy regulations. 2. Age =18 years at the time of informed consent. 3. Naïve to fumaric acid esters (e.g., DMF, Fumaderm®, compounded fumarates). 4. Diagnosed with RRMS and satisfies the approved therapeutic indication for DMF. 5. Subjects of childbearing potential must practice effective contraception and be willing and able to continue contraception during the study through at least the Week 12 Visit. For further details of contraceptive requirements for this study. 6. Ability to complete the tolerability scales accurately using the eDiary and ability to complete the paper Flushing Diaries. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 220 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Candidates will be excluded from study entry if any of the following exclusion criteria exist at the Screening/Baseline Visit or at the time point specified in the individual criterion listed: 1. Inability or unwillingness to comply with study requirements or, at the discretion of the Investigator, is deemed unsuitable for study participation. 2. 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. 3. Known active malignancies (subjects with cutaneous basal cell carcinoma that has been completely excised prior to study entry remain eligible). 4. Chronic use (=7 consecutive days) of ASA- or NSAID-containing products within the month prior to enrolment in the study. 5. A known intolerance to ASA. 6. Active peptic ulceration or a history of peptic ulceration, hemophilia or other clotting disorders, or gout. 7. Known hypersensitivity reactions (e.g., bronchospasm, rhinitis, urticaria) in response to ASA or NSAID administration. 8. Impaired hepatic or renal function, in the opinion of the Investigator. 9. Female subject is pregnant, lactating, or will be attempting to become pregnant during the Double-Blind Period of the study. 10. Currently participating in another interventional clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate whether 150 mg enteric-coated ASA taken BID with 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 RRMS compared with ASA-placebo administered with DMF in the clinical practice setting.;Secondary Objective: The secondary objectives of this study in this study population are: 1. To evaluate the safety and tolerability of DMF administered with and without enteric-coated ASA in the clinical practice setting. 2. 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.;Primary end point(s): The primary endpoints are as follows: 1. The incidence of subject-reported flushing events based on the Modified Global Flushing Severity Scale (MGFSS) and Modified Flushing Severity Scale (MFSS) data recorded on the hand-held subject reporting device (eDiary) during the first 4 weeks of the study 2. The severity of subject-reported flushing events based on the MGFSS and MFSS data recorded on the eDiary during the first 4 weeks of the study;Timepoint(s) of evaluation of this end point: The first 4 weeks of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are as follows: 1. Overall incidence of subject-reported flushing events during Weeks 5 through 8 and Weeks 9 through 12 of the study using MGFSS and MFSS data recorded on the eDiary 2. Severity of subject-reported flushing events during Week 5 through 8 and Weeks 9 through 12 of the study using MGFSS and MFSS data recorded on the eDiary 3. Duration of subject-reported flushing events during Weeks 1 through 4, Weeks 5 through 8, and Weeks 9 through 12 of the study based on the MGFSS and MFSS data recorded on the eDiary 4. Overall incidence of subject-reported flushing events using data obtained from the paper Flushing Diaries during Weeks 13 through 48 of the study 5. Incidence of treatment discontinuation and study withdrawal due to any AE 6. Incidence of treatment discontinuation and study withdrawal due to flushing events 7. Incidence of treatment-emergent AEs (excluding nonserious flushing events or flushing events that lead to treatment discontinuation or study withdrawal) 8. Incidence of SAEs 9. Change from Baseline to Week 24 and Week 48 in SF-36 and EQ-5D-5L assessments (quality-of-life measurements);Timepoint(s) of evaluation of this end point: 1. During Weeks 5 through 8 and Weeks 9 through 12 of the study 2. During Week 5 through 8 and Weeks 9 through 12 of the study 3. During Weeks 1 through 4, Weeks 5 through 8, and Weeks 9 through 12 of the study 4. During Weeks 13 through 48 of the study 5. When the subject withdraws from treatment/the study, or at week 48 6. When the subject withdraws from treatment/the study, or at week 48 7. When the subject withdraws from treatment/the study, or at week 48 8. At week 48 9. Week 24 and then Week 48 | — |
Countries
Ireland, United Kingdom
Contacts
Public ContactClinical Trials - Neurology
Biogen Idec Research Limited
Outcome results
None listed