Adherence to Treatment With Tecfidera™ in Multiple Sclerosis Patients (ADIMS)

University of South Florida

Status: Completed

Conditions: Multiple Sclerosis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02099370

US-BGT-13-10458

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.