Study to Evaluate Whether a Medication Event Monitoring System (MEMS) Can Improve Adherence to Tecfidera Treatment in Multiple Sclerosis Patients.
Public ClinicalTrials.gov record NCT02343159. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02343159
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 84 participants
Conditions and interventions
Conditions
Interventions
- dimethyl fumarate Drug
- Medication Event Monitoring System (MEMS) Device
- Adherence counseling Behavioral
Drug · Device · Behavioral
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2015 (Actual)
- Primary completion
- Apr 15, 2016 (Actual)
- Completion
- Apr 15, 2016 (Actual)
- Last update posted
- May 16, 2017
2015 – 2016
United States locations
- U.S. sites
- 29
- U.S. states
- 17
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Homewood | Alabama | 35209 | — |
| Research Site | Pheonix | Arizona | 85018 | — |
| Research Site | Carlsbad | California | 92011 | — |
| Research Site | Los Angeles | California | 90095 | — |
| Research Site | Panorama City | California | 91402 | — |
| Research Site | Sacramento | California | 95816 | — |
| Research Site | Aurora | Colorado | 80045 | — |
| Research Site | Colorado Springs | Colorado | 80907 | — |
| Research Site | Fairfield | Connecticut | 06824 | — |
| Research Site | Gainesville | Florida | 32607 | — |
| Research Site | Ormond Beach | Florida | 32174 | — |
| Research Site | Tampa | Florida | 33612 | — |
| Research Site | Vero Beach | Florida | 32960 | — |
| Research Site | Merrillville | Indiana | 46410 | — |
| Research Site | Wichita | Kansas | 67214 | — |
| Research Site | Lexington | Kentucky | 40513 | — |
| Research Site | Auburn | Maine | 04210 | — |
| Research Site | Boston | Massachusetts | 02135 | — |
| Research Site | St Louis | Missouri | 63141 | — |
| Research Site | Akron | Ohio | 44320 | — |
| Research Site | Columbus | Ohio | 43221 | — |
| Research Site | Sandusky | Ohio | 44870 | — |
| Research Site | Toledo | Ohio | 43623 | — |
| Research Site | Bend | Oregon | 97701 | — |
| Research Site | Portland | Oregon | 97225 | — |
| Research Site | Hodges | South Carolina | 29653-9181 | — |
| Research Site | Mt. Pleasant | South Carolina | 29464 | — |
| Research Site | Round Rock | Texas | 78681 | — |
| Research Site | Winchester | Virginia | 22601 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02343159, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 16, 2017 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02343159 live on ClinicalTrials.gov.