Adherence to Treatment With Tecfidera™ in Multiple Sclerosis Patients

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT02099370
• Lead Sponsor: University of South Florida

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-21
• Study First Submitted QC: 2014-03-27
• Study First Posted: 2014-03-28
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-01
• Last Update Posted: 2020-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
adherence rates to Tecfidera	over one year

Trial Locations

Locations (1)

USF Carol and Frank Morsani Center for Advanced Healthcare; 🇺🇸 Tampa, Florida, United States