Multiple Sclerosis Clinical Trial

Study to Evaluate Whether a Medication Event Monitoring System (MEMS) Can Improve Adherence to Tecfidera Treatment in Multiple Sclerosis Patients.

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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Multiple Sclerosis

Phase:

Phase 4

Estimated Enrollment:

84

Study ID:

NCT02343159

Recruitment Status:

Terminated

Sponsor:

Biogen

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There are 29 Locations for this study

See Locations Near You

Research Site
Homewood Alabama, 35209, United States
Research Site
Pheonix Arizona, 85018, United States
Research Site
Carlsbad California, 92011, United States
Research Site
Los Angeles California, 90095, United States
Research Site
Panorama City California, 91402, United States
Research Site
Sacramento California, 95816, United States
Research Site
Aurora Colorado, 80045, United States
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Colorado Springs Colorado, 80907, United States
Research Site
Fairfield Connecticut, 06824, United States
Research Site
Gainesville Florida, 32607, United States
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Ormond Beach Florida, 32174, United States
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Tampa Florida, 33612, United States
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Vero Beach Florida, 32960, United States
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Merrillville Indiana, 46410, United States
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Wichita Kansas, 67214, United States
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Lexington Kentucky, 40513, United States
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Auburn Maine, 04210, United States
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Boston Massachusetts, 02135, United States
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St. Louis Missouri, 63141, United States
Research Site
Akron Ohio, 44320, United States
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Columbus Ohio, 43221, United States
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Sandusky Ohio, 44870, United States
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Toledo Ohio, 43623, United States
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Bend Oregon, 97701, United States
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Portland Oregon, 97225, United States
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Hodges South Carolina, 29653, United States
Research Site
Mt. Pleasant South Carolina, 29464, United States
Research Site
Round Rock Texas, 78681, United States
Research Site
Winchester Virginia, 22601, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 4

Estimated Enrollment:

84

Study ID:

NCT02343159

Recruitment Status:

Terminated

Sponsor:


Biogen

How clear is this clinincal trial information?

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