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NCT02343159 · ClinicalTrials.gov registry record · Phase 4
Study to Evaluate Whether a Medication Event Monitoring System (MEMS) Can Improve Adherence to Tecfidera Treatment in Multiple Sclerosis Patients.
A Phase 4 study, sponsored by Biogen.
- Terminated
- Registry status
- Phase 4
- Development phase
- 84
- Enrollment target
NCT02343159: Clinical Trial Phase 4 study, sponsored by Biogen.
NCT02343159 is a Phase 4 study that was terminated before completion, run by Biogen. The registered enrollment target is 84 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02343159, a Phase 4 study, was terminated before completion, sponsored by Biogen.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 84 participants
- Enrollment target
Study 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.
Primary Outcome
Adherence is defined as the proportion of time on treatment over the study observation time period, times the proportion of actual DMF doses taken per label according to feedback from MEMS data over the total expected DMF doses per label during a treatment period.
Interventions
- DRUG dimethyl fumarate
- DEVICE Medication Event Monitoring System (MEMS)
- BEHAVIORAL Adherence counseling
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2015-02-28 |
| Est. Completion | 2016-04-15 |
| Phase | Phase 4 |
Why NCT02343159 stopped before completion
NCT02343159 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 3 interventions - of which dimethyl fumarate is the first listed.
NCT02343159 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02343159 about?
NCT02343159 is a clinical study titled "Study to Evaluate Whether a Medication Event Monitoring System (MEMS) Can Improve Adherence to Tecfidera Treatment in Multiple Sclerosis Patients.". 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 ...
What is the current status of trial NCT02343159?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 84 participants. The study started on 2015-02-28. Estimated completion is 2016-04-15.
What interventions are being tested in trial NCT02343159?
The interventions under investigation include: dimethyl fumarate (DRUG), Medication Event Monitoring System (MEMS) (DEVICE), Adherence counseling (BEHAVIORAL).
Who is sponsoring clinical trial NCT02343159?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02343159's enrollment target sits among peer trials
84 929th of 2000 higher than 1,064 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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