Study to Evaluate Whether a Medication Event Monitoring System (MEMS) Can Improve Adherence to Tecfidera Treatment in Multiple Sclerosis Patients.
NCT ID: NCT02343159
Last Updated: 2017-05-16
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
84 participants
INTERVENTIONAL
2015-02-28
2016-04-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Arm 1: Standard MEMS Cap
A standard MEMS cap that records the time and date when the bottle is opened without a visual LCD reader. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
dimethyl fumarate
120 mg and 240 mg delayed release capsules
Medication Event Monitoring System (MEMS)
The MEMS automatically compiles drug dosing history data by electronically recording the date and time of each opening of the medication container
Arm 2: Smart MEMS Cap
A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings). Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
dimethyl fumarate
120 mg and 240 mg delayed release capsules
Medication Event Monitoring System (MEMS)
The MEMS automatically compiles drug dosing history data by electronically recording the date and time of each opening of the medication container
Arm 3: Smart MEMS Cap + Counseling
A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings) and an adherence counseling intervention. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
dimethyl fumarate
120 mg and 240 mg delayed release capsules
Medication Event Monitoring System (MEMS)
The MEMS automatically compiles drug dosing history data by electronically recording the date and time of each opening of the medication container
Adherence counseling
A telephone call to discuss adherence and individualized strategies based on data collected via smart device (i.e., LCD reader)
Interventions
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dimethyl fumarate
120 mg and 240 mg delayed release capsules
Medication Event Monitoring System (MEMS)
The MEMS automatically compiles drug dosing history data by electronically recording the date and time of each opening of the medication container
Adherence counseling
A telephone call to discuss adherence and individualized strategies based on data collected via smart device (i.e., LCD reader)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* History of severe allergic or anaphylactic reactions or known drug hypersensitivity
* Are participating, planning to participate, or have participated in the Tecfidera QuickStart Program
18 Years
65 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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Research Site
Homewood, Alabama, United States
Research Site
Pheonix, Arizona, United States
Research Site
Carlsbad, California, United States
Research Site
Los Angeles, California, United States
Research Site
Panorama City, California, United States
Research Site
Sacramento, California, United States
Research Site
Aurora, Colorado, United States
Research Site
Colorado Springs, Colorado, United States
Research Site
Fairfield, Connecticut, United States
Research Site
Gainesville, Florida, United States
Research Site
Ormond Beach, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
Vero Beach, Florida, United States
Research Site
Merrillville, Indiana, United States
Research Site
Wichita, Kansas, United States
Research Site
Lexington, Kentucky, United States
Research Site
Auburn, Maine, United States
Research Site
Boston, Massachusetts, United States
Research Site
St Louis, Missouri, United States
Research Site
Akron, Ohio, United States
Research Site
Columbus, Ohio, United States
Research Site
Sandusky, Ohio, United States
Research Site
Toledo, Ohio, United States
Research Site
Bend, Oregon, United States
Research Site
Portland, Oregon, United States
Research Site
Hodges, South Carolina, United States
Research Site
Mt. Pleasant, South Carolina, United States
Research Site
Round Rock, Texas, United States
Research Site
Winchester, Virginia, United States
Countries
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Other Identifiers
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109MS413
Identifier Type: -
Identifier Source: org_study_id
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