Study to Evaluate Whether a Medication Event Monitoring System (MEMS) Can Improve Adherence to Tecfidera Treatment in Multiple Sclerosis Patients.
| Status: | Terminated |
|---|---|
| Conditions: | Neurology, Neurology, Multiple Sclerosis |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | February 2015 |
| End Date: | February 2016 |
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.
"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.
Key Inclusion Criteria:
- The candidate is a DMF-naïve patient
- Have a diagnosis of relapsing forms of MS and satisfy the approved therapeutic
indication for DMF
- Have a recent (i.e., within the previous 6 months) complete blood count with results
that do not preclude the patient's participation in the study, in the judgment of the
Investigator
Key Exclusion Criteria:
- Have comorbid conditions that preclude participation in the study, as determined by
the Investigator
- History of severe allergic or anaphylactic reactions or known drug hypersensitivity
- Are participating, planning to participate, or have participated in the Tecfidera
QuickStart Program
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
We found this trial at
22
sites
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