Study to Evaluate Whether a Medication Event Monitoring System (MEMS)
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.
What it found
The trial ended early for another reason (see below).
Reason given: Sponsor Decision
What was tested
Treatment tested
- Dimethyl fumarate
Kelch-like ECH-associated protein 1 inhibitor
- Medication Event Monitoring System (MEMS)
- Adherence counseling
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Arm 1: Standard MEMS Cap | 26 | 1 (3.8%) | |
| Arm 2: Smart MEMS Cap | 26 | 1 (3.8%) | |
| Arm 3: Smart MEMS Cap + Counseling | 27 | 0 (0.0%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Overall Adherence Rates at Month 12: Arm 3 vs. Arm 1
Month 12
Quality of life (reported by participants)
Other measures (7)
Overall Adherence Rates at Month 12: Arm 2 vs. Arm 1
Month 12
Quality of life (reported by participants)Overall Adherence Rates at Month 6: Arm 3 vs. Arm 1
Month 6
Quality of life (reported by participants)Overall Adherence Rates at Month 6: Arm 2 vs. Arm 1
Month 6
Quality of life (reported by participants)Persistence Rates at Months 6 and 12
Month 6, Month 12
Compliance Rates at Month 6 and 12
Month 6, Month 12
Multiple Sclerosis Impact Scale (MSIS-29)
Month 6, Month 12
Quality of life (reported by participants)Work Productivity and Activity Impairment Questionnaire (WPAI: MS Version 2.0)
Month 6, Month 12
Who could take part
Relapsing MS · 18 to 65
Show the full criteria
Inclusion criteria
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
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
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History
Started
Feb 2015
Main results due
Apr 2016
Finished
Apr 2016
Results posted
May 2017