Multiple Sclerosis Clinical Trial
Official title:
A Multicenter, Open-label Phase IV Study to Evaluate Whether a Medication Event Monitoring System (MEMS®) Can Improve Adherence to Tecfidera® (Delayed-release Dimethyl Fumarate) Treatment in Multiple Sclerosis Patients.
The primary objective of the study is to determine whether a MEMS® cap with a LCD reader (a
"smart" cap) along with additional patient counseling intervention (Arm 3) can improve
adherence to dimethyl fumarate (DMF) treatment in MS patients as compared to a MEMS
(Medication Event Monitoring System) cap without a LCD reader (a "standard" cap) and no
patient counseling intervention (standard of care, Arm 1) at Month 12.
The secondary objectives of this study in this study population are: To determine if data
display on a smart MEMS cap with a LCD reader (Arm 2) can improve adherence as compared to a
standard MEMS cap without a LCD reader (Arm 1) at Month 12; To determine whether the
addition of patient counseling intervention based on MEMS data (Arm 3), or data display from
a MEMS cap with LCD reader (Arm 2) can improve adherence compared to standard MEMS cap
without a LCD reader (Arm 1) at Month 6; To assess persistence and compliance at Months 6
and 12 for all arms; To assess the association between adherence and patient reported
outcomes (PROs) for all arms including Multiple Sclerosis Impact Scale (MSIS-29), and the
Work Productivity and Activity Impairment Questionnaire (WPAI): MS v2.0.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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