Adherence to Treatment With Tecfidera™ in Multiple Sclerosis Patients

NCT ID: NCT02099370

Last Updated: 2020-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2016-01-31

Brief Summary

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The investigators are measuring the adherence rates of an oral MS drug that is to be administered twice-daily. The investigators would like to observe any patterns that might indicate factors that greatly affect adherence.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Must give written informed consent and any authorizations required by local law (e.g., Protected Health Information \[PHI\]).
* Aged 18 at the time of informed consent.
* Must have a relapsing form of MS.
* Male subjects and female subjects of child-bearing potential (including female subjects who are not post-menopausal for at least 1 year) must be willing to practice effective contraception (as defined by the investigator) during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.

Exclusion Criteria

* Progressive form of MS
* History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
* Female subjects considering becoming pregnant while in the study.
* Female subjects who are currently pregnant or breast-feeding.
* Unwillingness or inability to comply with the requirements of the protocol including the presence of any conditional (physical, mental or social) that is likely to affect the subject's ability to comply with the protocol.
* Any other reason that, in opinion of the Investigator and/or the Sponsor, the subject is determined to be unsuitable for enrollment in this study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biogen

INDUSTRY

Sponsor Role collaborator

University of South Florida

OTHER

Sponsor Role lead

Responsible Party

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Derrick Scott Robertson

MD, Multiple Sclerosis Center Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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USF Carol and Frank Morsani Center for Advanced Healthcare

Tampa, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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US-BGT-13-10458

Identifier Type: -

Identifier Source: org_study_id

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