Adherence to Treatment With Tecfidera™ in Multiple Sclerosis Patients
Status: | Completed |
---|---|
Conditions: | Neurology, Neurology, Multiple Sclerosis |
Therapuetic Areas: | Neurology, Other |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | March 2014 |
End Date: | January 2016 |
A Single-center Prospective Measurement of Adherence to Treatment With Tecfidera™ in Multiple Sclerosis Patients.
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.
administered twice-daily. The investigators would like to observe any patterns that might
indicate factors that greatly affect adherence.
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.
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