NCT02343159

Study to Evaluate Whether a Medication Event Monitoring System (MEMS) Can Improve Adherence to Tecfidera Treatment in Multiple Sclerosis Patients.

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.

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to determine whether a Medication Event Monitoring System (MEMS®) cap with a liquid crystal display (LCD) reader (a "smart" cap) along with additional patient counseling intervention (Arm 3) can improve adherence to dimethyl fumarate (DMF) treatment in Multiple Sclerosis (MS) patients as compared to a MEMS cap without an 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 an LCD reader (Arm 2) can improve adherence as compared to a standard MEMS cap without an 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 an LCD reader (Arm 2) can improve adherence compared to standard MEMS cap without an 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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	dimethyl fumarate	120 mg and 240 mg delayed release capsules
DEVICE	Medication Event Monitoring System (MEMS)	The MEMS automatically compiles drug dosing history data by electronically recording the date and time of each opening of the medication container
BEHAVIORAL	Adherence counseling	A telephone call to discuss adherence and individualized strategies based on data collected via smart device (i.e., LCD reader)

Timeline

• Start date: 2015-02-28
• Primary completion: 2016-04-15
• Completion: 2016-04-15
• First posted: 2015-01-21
• Last updated: 2017-05-16
• Results posted: 2017-05-16

Locations

29 sites across 1 country: United States