Phase 4 Study of Effect of Aspirin on Flushing in Dimethyl Fumarate-Treated Participants With Relapsing-Remitting Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT02090413
• Date of registration: 14/03/2014
• Prospective Registration: Yes
• Primary sponsor: Biogen
• Public title: Phase 4 Study of Effect of Aspirin on Flushing in Dimethyl Fumarate-Treated Participants With Relapsing-Remitting Multiple Sclerosis ASSURE
• Scientific title: A Phase 4, Randomized, Double-Blind Study With a Safety Extension Period to Evaluate the Effect of Aspirin on Flushing Events in Subjects With Relapsing-Remitting Multiple Sclerosis Treated With Tecfidera® (Dimethyl Fumarate) Delayed-Release Capsules
• Date of first enrolment: May 2014
• Target sample size: 241
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02090413
• Study type: Interventional
• Phase: Phase 4

Countries of recruitment

Ireland, United Kingdom

Contacts

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Relapsing-Remitting Multiple Sclerosis

Intervention(s)

Drug: acetylsalicylic acid

Drug: ASA-Placebo

Drug: dimethyl fumarate

Primary Outcome(s)

Worst Severity Scores of Overall Flushing During the First 4 Weeks of Treatment, as Assessed by MGFSS [Time Frame: Day 2 to Week 4]

Percentage of Participants Reporting Overall Flushing Events During the First 4 Weeks of Treatment, as Assessed by the Modified Flushing Severity Scale (MFSS) [Time Frame: Day 1 to Week 4]

Percentage of Participants Reporting Overall Flushing Events During the First 4 Weeks of Treatment, as Assessed by the Modified Global Flushing Severity Scale (MGFSS) [Time Frame: Day 2 to Week 4]

Worst Severity Scores of Overall Flushing During the First 4 Weeks of Treatment, as Assessed by MFSS [Time Frame: Day 1 to Week 4]

Secondary Outcome(s)

Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-5D-5L Questionnaire: Usual Activities [Time Frame: Baseline, Week 24, Week 48 or ET]

Change From Baseline at Weeks 24 and 48 in Quality of Life Measurements as Assessed by Short Form-36 (SF-36) Questionnaire: Physical Component Summary (PCS) [Time Frame: Baseline, Week 24, Week 48 or early termination (ET)]

Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-5D-5L Questionnaire: Anxiety/Depression [Time Frame: Baseline, Week 24, Week 48 or ET]

Change From Baseline at Weeks 24 and 48 in Quality of Life Measurements as Assessed by Short Form-36 (SF-36) Questionnaire: Mental Component Summary (MCS) [Time Frame: Baseline, Week 24, Week 48 or ET]

Percentage of Participants Reporting Overall Flushing Events During Weeks 5-8 and Weeks 9-12 of Treatment, as Assessed by MGFSS [Time Frame: Week 5 to Week 12]

Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-VAS [Time Frame: Baseline, Week 24, Week 48 or ET]

Number of Participants Discontinuing Treatment and Discontinuing the Study Due to Treatment-emergent Flushing AEs in the First 12 Weeks [Time Frame: Day 1 to Week 12]

Worst Severity Scores of Overall Flushing During Weeks 5-8 and Weeks 9-12 of the Study, as Assessed by MGFSS [Time Frame: Week 5 to Week 12]

Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-5D-5L Questionnaire: Pain/Discomfort [Time Frame: Baseline, Week 24, Week 48 or ET]

Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the European Quality of Life 5-Dimensions Questionnaire (EQ-5D-5L) Questionnaire: Mobility [Time Frame: Baseline, Week 24, Week 48 or ET]

Number of Participants Experiencing Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs in the First 12 Weeks [Time Frame: Day 1 to Week 12]

Number of Participants Experiencing Treatment-Emergent AEs, SAEs, and Discontinuations Due to AEs in Weeks 13 to 48 [Time Frame: Week 13 to Week 48]

Number of Participants With Self-Reported Flushing Events During Weeks 13 to 48 [Time Frame: Week 13 to Week 48]

Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-5D-5L Questionnaire: Self-Care [Time Frame: Baseline, Week 24, Week 48 or ET]

Duration of Flushing Episodes During Weeks 1-4, 5-8 and 9-12 of the Study, as Assessed by MFSS [Time Frame: Day 1 to Week 12]

Duration of Flushing Episodes During Weeks 1-4, 5-8 and 9-12 of the Study, as Assessed by MGFSS [Time Frame: Day 1 to Week 12]

Number of Participants Discontinuing Treatment and Discontinuing the Study Due to Treatment-Emergent Flushing AEs in Weeks 13 to 48 [Time Frame: Week 13 to Week 48]

Percentage of Participants Reporting Overall Flushing Events During Weeks 5-8 and Weeks 9-12 of Treatment, as Assessed by MFSS [Time Frame: Week 5 to Week 12]

Worst Severity Scores of Overall Flushing During Weeks 5-8 and Weeks 9-12 of the Study, as Assessed by MFSS [Time Frame: Week 5 to Week 12]

Secondary ID(s)

2013-001895-40

109MS406

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 28/12/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02090413