A Single-center Prospective Measurement of Adherence to Treatment With Tecfidera™ in Multiple Sclerosis Patients.

University of South Florida1 site in 1 country34 target enrollmentMarch 2014

ConditionsMultiple Sclerosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Multiple Sclerosis
Sponsor: University of South Florida
Enrollment: 34
Locations: 1
Primary Endpoint: adherence rates to Tecfidera
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

March 2014

End Date

January 2016

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

University of South Florida

Responsible Party

Principal Investigator

Derrick Scott Robertson

MD, Multiple Sclerosis Center Director

University of South Florida

Eligibility Criteria

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.