A Phase 4 interventional study of dimethyl fumarate and Medication Event Monitoring System (MEMS) in Multiple Sclerosis, sponsored by Biogen. Terminated at 29 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-05-16.
Sponsored by Biogen · Phase 4, Interventional, and Health services research
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 84 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
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Of its 98 completed or terminated interventional studies of FDA-regulated products, 49 (50%) have results posted.
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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.
Drug: dimethyl fumarate · Device: Medication Event Monitoring System (MEMS)
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.
Drug: dimethyl fumarate · Device: Medication Event Monitoring System (MEMS)
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.
Drug: dimethyl fumarate · Device: Medication Event Monitoring System (MEMS) · Behavioral: Adherence counseling
120 mg and 240 mg delayed release capsules
Also known as: Tecfidera, DMF, BG000012
The MEMS automatically compiles drug dosing history data by electronically recording the date and time of each opening of the medication container
A telephone call to discuss adherence and individualized strategies based on data collected via smart device (i.e., LCD reader)
Overall Adherence Rates at Month 12: Arm 3 vs. Arm 1
Adherence is defined as the proportion of time on treatment over the study observation time period, times the proportion of actual DMF doses taken per label according to feedback from MEMS data over the total expected DMF doses per label during a treatment period.
Time frame: Month 12
Overall Adherence Rates at Month 12: Arm 2 vs. Arm 1
Adherence is defined as the proportion of time on treatment over the study observation time period, times the proportion of actual DMF doses taken per label according to feedback from MEMS data over the total expected DMF doses per label during a treatment period.
Time frame: Month 12
Overall Adherence Rates at Month 6: Arm 3 vs. Arm 1
Adherence is defined as the proportion of time on treatment over the study observation time period, times the proportion of actual DMF doses taken per label according to feedback from MEMS data over the total expected DMF doses per label during a treatment period.
Time frame: Month 6
Overall Adherence Rates at Month 6: Arm 2 vs. Arm 1
Adherence is defined as the proportion of time on treatment over the study observation time period, times the proportion of actual DMF doses taken per label according to feedback from MEMS data over the total expected DMF doses per label during a treatment period.
Time frame: Month 6
Persistence Rates at Months 6 and 12
Persistence rates defined as the proportion of time on treatment over the study observation time period.
Time frame: Month 6, Month 12
Compliance Rates at Month 6 and 12
Compliance rates defined as the proportion of actual DMF doses taken per label according to feedback from MEMS data over total expected DMF doses per label during treatment period.
Time frame: Month 6, Month 12
Multiple Sclerosis Impact Scale (MSIS-29)
The 29-item MSIS-29 is a participant-reported outcome measure to assess the impact of MS on day-to-day life during the past 2 weeks from a participants perspective; it measures 20 physical items and 9 psychological items. The physical score is generated by summing individual items and then transforming to a scale with a range of 0 to 100, where high scores indicate worse health.
Time frame: Month 6, Month 12
Work Productivity and Activity Impairment Questionnaire (WPAI: MS Version 2.0)
The WPAI questionnaire is a validated instrument to measure impairments in work and activities. The WPAI yields four types of scores: 1. Absenteeism (work time missed) 2. Presenteesism (impairment at work / reduced on-the-job effectiveness) 3. Work productivity loss (overall work impairment / absenteeism plus presenteeism) 4. Activity Impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Time frame: Month 6, Month 12
| Milestone | Arm 1: Standard MEMS Cap | Arm 2: Smart MEMS Cap | Arm 3: Smart MEMS Cap + Counseling |
|---|---|---|---|
| Started | 27 | 27 | 30 |
| Completed | 1 | 1 | 0 |
| Not completed | 26 | 26 | 30 |
| Withdrew: Early study termination | 16 | 19 | 23 |
| Withdrew: Physician decision | 2 | 0 | 1 |
| Withdrew: Withdrawal by subject | 3 | 0 | 2 |
| Withdrew: Lost to follow-up | 0 | 2 | 2 |
| Withdrew: Adverse event | 4 | 4 | 2 |
| Withdrew: Sponsor decision | 0 | 1 | 0 |
| Withdrew: Enrollment error | 1 | 0 | 0 |
Adherence is defined as the proportion of time on treatment over the study observation time period, times the proportion of actual DMF doses taken per label according to feedback from MEMS data over the total expected DMF doses per label during a treatment period.
No measurements were reported for this outcome.
Adherence is defined as the proportion of time on treatment over the study observation time period, times the proportion of actual DMF doses taken per label according to feedback from MEMS data over the total expected DMF doses per label during a treatment period.
No measurements were reported for this outcome.
Adherence is defined as the proportion of time on treatment over the study observation time period, times the proportion of actual DMF doses taken per label according to feedback from MEMS data over the total expected DMF doses per label during a treatment period.
No measurements were reported for this outcome.
Adherence is defined as the proportion of time on treatment over the study observation time period, times the proportion of actual DMF doses taken per label according to feedback from MEMS data over the total expected DMF doses per label during a treatment period.
No measurements were reported for this outcome.
Persistence rates defined as the proportion of time on treatment over the study observation time period.
No measurements were reported for this outcome.
Compliance rates defined as the proportion of actual DMF doses taken per label according to feedback from MEMS data over total expected DMF doses per label during treatment period.
No measurements were reported for this outcome.
The 29-item MSIS-29 is a participant-reported outcome measure to assess the impact of MS on day-to-day life during the past 2 weeks from a participants perspective; it measures 20 physical items and 9 psychological items. The physical score is generated by summing individual items and then transforming to a scale with a range of 0 to 100, where high scores indicate worse health.
No measurements were reported for this outcome.
The WPAI questionnaire is a validated instrument to measure impairments in work and activities. The WPAI yields four types of scores: 1. Absenteeism (work time missed) 2. Presenteesism (impairment at work / reduced on-the-job effectiveness) 3. Work productivity loss (overall work impairment / absenteeism plus presenteeism) 4. Activity Impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
No measurements were reported for this outcome.
Collected over Collected between the time of informed consent and month 12 or early discontinuation visit.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1: Standard MEMS Cap | — | 1/26 (3.8%) | 17/26 (65.4%) |
| Arm 2: Smart MEMS Cap | — | 1/26 (3.8%) | 22/26 (84.6%) |
| Arm 3: Smart MEMS Cap + Counseling | — | 0/27 (0%) | 17/27 (63%) |
| Event | Arm 1: Standard MEMS Cap | Arm 2: Smart MEMS Cap | Arm 3: Smart MEMS Cap + Counseling |
|---|---|---|---|
| Suicide attemptPsychiatric disorders | 0/26 | 1/26 | 0/27 |
| EncephalopathyNervous system disorders | 0/26 | 1/26 | 0/27 |
| VomitingGastrointestinal disorders | 1/26 | 0/26 | 0/27 |
| Intentional overdoseInjury, poisoning and procedural complications | 0/26 | 1/26 | 0/27 |
| Toxicity to various agentsInjury, poisoning and procedural complications | 0/26 | 1/26 | 0/27 |
| Event | Arm 1: Standard MEMS Cap | Arm 2: Smart MEMS Cap | Arm 3: Smart MEMS Cap + Counseling |
|---|---|---|---|
| FlushingVascular disorders | 9/26 | 10/26 | 8/27 |
| DiarrhoeaGastrointestinal disorders | 7/26 | 4/26 | 4/27 |
| NauseaGastrointestinal disorders | 2/26 | 5/26 | 2/27 |
| Abdominal pain upperGastrointestinal disorders | 4/26 | 1/26 | 4/27 |
| VomitingGastrointestinal disorders | 1/26 | 2/26 | 3/27 |
| Seasonal allergyImmune system disorders | 0/26 | 2/26 | 0/27 |
| InsomniaPsychiatric disorders | 1/26 | 2/26 | 1/27 |
| Multiple sclerosis relapseNervous system disorders | 2/26 | 2/26 | 1/27 |
| Abdominal distensionGastrointestinal disorders | 0/26 | 2/26 | 0/27 |
| HaemorrhoidsGastrointestinal disorders | 0/26 | 2/26 | 0/27 |
The Intent-to-treat (ITT) population will be used for analysis. ITT is defined as all participants who were randomized and received at least one dose of study treatment.
| Age, Customized(Participants) | Arm 1: Standard MEMS Cap | Arm 2: Smart MEMS Cap | Arm 3: Smart MEMS Cap + Counseling | Total |
|---|---|---|---|---|
| 18 - 50 Years | 21 | 19 | 17 | 57 |
| > 50 Years | 5 | 7 | 10 | 22 |
| Sex: Female, Male(Participants) | Arm 1: Standard MEMS Cap | Arm 2: Smart MEMS Cap | Arm 3: Smart MEMS Cap + Counseling | Total |
|---|---|---|---|---|
| Female | 22 | 23 | 23 | 68 |
| Male | 4 | 3 | 4 | 11 |
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