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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 is a Phase 4 study that was terminated before completion, run by Biogen. The registered enrollment target is 84 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02343159
The ClinicalTrials.gov registry entry for NCT02343159 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which dimethyl fumarate is the first listed.
NCT02343159 reports 0 study locations.
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.
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