Ignite Creation Date:
2024-05-06 @ 3:40 AM
Last Modification Date:
2024-10-26 @ 11:37 AM
Study NCT ID:
NCT02343159
Status:
TERMINATED
Last Update Posted:
2017-05-16
First Post:
2015-01-09
Brief Title:
Study to Evaluate Whether a Medication Event Monitoring System MEMS Can Improve Adherence to Tecfidera Treatment in Multiple Sclerosis Patients
Sponsor:
Biogen
Organization:
Biogen
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor Decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 v20
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 v20
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None