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

NCT ID: NCT02090413

Last Updated: 2016-12-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

241 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Relapsing-Remitting Multiple Sclerosis

Keywords

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multiple sclerosis flushing aspirin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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DMF + ASA 150 mg BID

DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48.

ASA 150 mg is taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA is prohibited; between Weeks 9 and 48, ASA is allowed as needed.)

Group Type EXPERIMENTAL

dimethyl fumarate

Intervention Type DRUG

acetylsalicylic acid

Intervention Type DRUG

enteric-coated capsule

DMF + ASA 75 mg QAM

DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48.

ASA 75 mg is taken in the morning (QAM) and ASA-Placebo is taken in the evening (QPM) from Day 1 through Week 4. (Between Weeks 5 and 8, ASA is prohibited; between Weeks 9 and 48, ASA is allowed as needed.)

Group Type EXPERIMENTAL

dimethyl fumarate

Intervention Type DRUG

acetylsalicylic acid

Intervention Type DRUG

enteric-coated capsule

ASA-Placebo

Intervention Type DRUG

matched placebo

DMF + ASA-Placebo BID

DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48.

ASA-Placebo is taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA is prohibited; between Weeks 9 and 48, ASA is allowed as needed.)

Group Type EXPERIMENTAL

dimethyl fumarate

Intervention Type DRUG

ASA-Placebo

Intervention Type DRUG

matched placebo

Interventions

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dimethyl fumarate

Intervention Type DRUG

acetylsalicylic acid

enteric-coated capsule

Intervention Type DRUG

ASA-Placebo

matched placebo

Intervention Type DRUG

Other Intervention Names

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BG00012 Tecfidera DMF ASA aspirin placebo

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

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Research Site

Cork, , Ireland

Site Status

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Dublin, , Ireland

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Dublin, , Ireland

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Dublin, , Ireland

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Basingstoke, , United Kingdom

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Birmingham, , United Kingdom

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Cardiff, , United Kingdom

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Edinburgh, , United Kingdom

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Exeter, , United Kingdom

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Glasgow, , United Kingdom

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Leicester, , United Kingdom

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Liverpool, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Newcastle upon Tyne, , United Kingdom

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Norwich, , United Kingdom

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Nottingham, , United Kingdom

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Plymouth, , United Kingdom

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Salford, , United Kingdom

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Swansea, , United Kingdom

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Countries

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Ireland United Kingdom

Other Identifiers

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2013-001895-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

109MS406

Identifier Type: -

Identifier Source: org_study_id