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Sponsor Decision
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Standard MEMS Cap | Experimental | 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. |
|
| Arm 2: Smart MEMS Cap | Experimental | 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. |
|
| Arm 3: Smart MEMS Cap + Counseling | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dimethyl fumarate | Drug | 120 mg and 240 mg delayed release capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 12 |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Homewood | Alabama | 35209 | United States | ||
| Research Site |
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Arm 2: Smart MEMS Cap |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Medication Event Monitoring System (MEMS) | Device | The MEMS automatically compiles drug dosing history data by electronically recording the date and time of each opening of the medication container |
|
| Adherence counseling | Behavioral | 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 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. |
| 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. | 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. | 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. | 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. | 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. | Month 6, Month 12 |
| 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 |
| Research Site | Colorado Springs | Colorado | 80907 | United States |
| Research Site | Fairfield | Connecticut | 06824 | United States |
| Research Site | Gainesville | Florida | 32607 | United States |
| Research Site | Ormond Beach | Florida | 32174 | United States |
| Research Site | Tampa | Florida | 33612 | United States |
| Research Site | Vero Beach | Florida | 32960 | United States |
| Research Site | Merrillville | Indiana | 46410 | United States |
| Research Site | Wichita | Kansas | 67214 | United States |
| Research Site | Lexington | Kentucky | 40513 | United States |
| Research Site | Auburn | Maine | 04210 | United States |
| Research Site | Boston | Massachusetts | 02135 | United States |
| Research Site | St Louis | Missouri | 63141 | United States |
| Research Site | Akron | Ohio | 44320 | United States |
| Research Site | Columbus | Ohio | 43221 | United States |
| Research Site | Sandusky | Ohio | 44870 | United States |
| Research Site | Toledo | Ohio | 43623 | United States |
| Research Site | Bend | Oregon | 97701 | United States |
| Research Site | Portland | Oregon | 97225 | United States |
| Research Site | Hodges | South Carolina | 29653-9181 | 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 |
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. |
| FG002 | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis. | Posted | Month 12 |
|
| ||||||||||||||||||||||
| Secondary | 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. | The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis. | Posted | Month 12 |
|
| ||||||||||||||||||||||
| Secondary | 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. | The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis. | Posted | Month 6 |
|
| ||||||||||||||||||||||
| Secondary | 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. | The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis. | Posted | Month 6 |
|
| ||||||||||||||||||||||
| Secondary | Persistence Rates at Months 6 and 12 | Persistence rates defined as the proportion of time on treatment over the study observation time period. | The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis. | Posted | Month 6, Month 12 |
| |||||||||||||||||||||||
| Secondary | 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. | The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis. | Posted | Month 6, Month 12 |
| |||||||||||||||||||||||
| Secondary | 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. | The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis. | Posted | Month 6, Month 12 |
| |||||||||||||||||||||||
| Secondary | 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. | The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis. | Posted | Month 6, Month 12 |
|
Collected between the time of informed consent and month 12 or early discontinuation visit.
Safety population: Defined as all subjects who received at least one dose of study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 1 | 26 | 17 | 26 | ||
| EG001 | 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. | 1 | 26 | 22 | 26 | ||
| EG002 | 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. | 0 | 27 | 17 | 27 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicide attempt | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fungal infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Allergy to arthropod sting | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bruxism | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Obsessive-compulsive disorder | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Stress | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Multiple sclerosis relapse | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bone contusion | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Transaminase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Anal incontinence | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Faeces discoloured | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pruritis | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pruritis generalized | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Skin tightness | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Posture abnormal | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Facial pain | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Feeling abnormal | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.1 | Systematic Assessment |
|
Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Biogen Study Medical Director | Biogen | clinicaltrials@biogen.com |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069462 | Dimethyl Fumarate |
| ID | Term |
|---|---|
| D005650 | Fumarates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
| > 50 Years |
|
| Male |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
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. |
|