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The primary objective of this study is to evaluate the effect of symptomatic therapies on gastrointestinal (GI)-related events reported by participants with relapsing forms of multiple sclerosis (MS) initiating therapy with dimethyl fumarate (DMF) in the clinical practice setting.
The secondary objectives of this study are as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dimethyl Fumarate | Experimental | 120 mg DMF twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants will be instructed to take the DMF dose with food (with a meal or within 1 hour after a meal). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BG00012 (DMF) | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Worst Severity Score of Overall Gastrointestinal (GI) Events, Modified Overall GI Symptom Scale (MOGISS) | Severity of GI-related events in DMF-treated participants using the MOGISS to measure GI symptoms, based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. | 12 Weeks |
| Worst Severity Score of Overall GI Events, Modified Acute Gl Symptom Scale | Severity of GI-related events in DMF-treated participants using the MAGISS to measure GI symptoms, based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. | 12 Weeks |
| Percentage of DMF-treated Participants Who Reported GI-related Symptoms and Who Utilized Symptomatic Therapy | Percentage of participants reporting GI symptoms on the MOGISS, by those who utilized symptomatic therapy. | 12 Weeks |
| Duration of GI-related Episodes in DMF-treated Participants | In participants who took symptomatic therapy, the median duration of acute GI episodes (in hours) was summarized for the overall treatment period, by symptom (nausea, diarrhea, lower abdominal pain, upper abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence). Table only includes the symptom duration for those symptoms with start and stop times entered in the eDiary (evaluable GI episodes), based on the MAGISS. | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of DMF-treated Participants Who Required GI Symptomatic Therapy | Percentage of participants reporting that they required GI symptomatic therapy, based on the MOGISS. | 12 Weeks |
| Participants' Use of Symptomatic Therapy, by Type and Category |
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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 | Cullman | Alabama | 35058 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26917993 | Background | Fox EJ, Vasquez A, Grainger W, Ma TS, von Hehn C, Walsh J, Li J, Zambrano J. Gastrointestinal Tolerability of Delayed-Release Dimethyl Fumarate in a Multicenter, Open-Label Study of Patients with Relapsing Forms of Multiple Sclerosis (MANAGE). Int J MS Care. 2016 Jan-Feb;18(1):9-18. doi: 10.7224/1537-2073.2014-101. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dimethyl Fumarate | 120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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The symptomatic therapies used by DMF-treated participants were self-reported by type and category. Each participant may have taken more than one symptomatic therapy type but was counted only once within each therapy category. Acetylsalicylic acid (ASA) is abbreviated in the table.
| 12 Weeks |
| Summary of Use and Days on Symptomatic Therapy, by Category | The total duration (in days) of use of each symptomatic therapy by participants as a result of GI symptoms experienced by DMF-treated participants is presented. If a participant had multiple different therapies on the same day, the days on symptomatic therapy was calculated as 1 day in the 'All Therapies' category. | 12 Weeks |
| Number of DMF-treated Participants Who Discontinued DMF Due to GI-related Events Requiring Symptomatic Therapy | The last symptomatic therapy prior to last dose of study medication was used to summarize the number of participants who discontinued DMF due to GI-related events. Participants may have taken more than one symptomatic therapy but are counted only once in the 'All Therapies' category. | 12 Weeks |
| Gilbert |
| Arizona |
| 85234 |
| United States |
| Research Site | Scottsdale | Arizona | 85258 | United States |
| Research Site | Fullerton | California | 92835 | United States |
| Research Site | Newport Beach | California | 92663 | United States |
| Research Site | Pasadena | California | 91105 | United States |
| Research Site | Englewood | Colorado | 80113 | United States |
| Research Site | Fort Collins | Colorado | 80528 | United States |
| Research Site | Danbury | Connecticut | 06810 | United States |
| Research Site | Maitland | Florida | 32751 | United States |
| Research Site | Naples | Florida | 34102 | United States |
| Research Site | North Palm Beach | Florida | 33408 | United States |
| Research Site | Port Charlotte | Florida | 33952 | United States |
| Research Site | Sarasota | Florida | 34239 | United States |
| Research Site | St. Petersburg | Florida | 33713 | United States |
| Research Site | Tampa | Florida | 33609 | United States |
| Research Site | Tampa | Florida | 33612 | United States |
| Research Site | Atlanta | Georgia | 30327 | United States |
| Research Site | Indianapolis | Indiana | 46256 | United States |
| Research Site | Milford | Massachusetts | 01757 | United States |
| Research Site | Golden Valley | Minnesota | 55422 | United States |
| Research Site | Patchogue | New York | 11772 | United States |
| Research Site | Charlotte | North Carolina | 28204 | United States |
| Research Site | Greensboro | North Carolina | 27405 | United States |
| Research Site | High Point | North Carolina | 27262 | United States |
| Research Site | Fargo | North Dakota | 58103 | United States |
| Research Site | Portland | Oregon | 97225 | United States |
| Research Site | Monroeville | Pennsylvania | 15215 | United States |
| Research Site | Cordova | Tennessee | 38018 | United States |
| Research Site | Franklin | Tennessee | 37064 | United States |
| Research Site | Knoxville | Tennessee | 37934 | United States |
| Research Site | Round Rock | Texas | 78681 | United States |
| Research Site | Salt Lake City | Utah | 84103 | United States |
| Research Site | Richmond | Virginia | 23298 | United States |
| Research Site | Roanoke | Virginia | 24018 | United States |
| Research Site | Tacoma | Washington | 98405 | United States |
| Research Site | Milwaukee | Wisconsin | 53215 | United States |
| Safety Population |
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| COMPLETED |
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| NOT COMPLETED |
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Safety Population (participants who received at least 1 dose of DMF, recorded in diary data)
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| ID | Title | Description |
|---|---|---|
| BG000 | Dimethyl Fumarate | 120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Worst Severity Score of Overall Gastrointestinal (GI) Events, Modified Overall GI Symptom Scale (MOGISS) | Severity of GI-related events in DMF-treated participants using the MOGISS to measure GI symptoms, based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. | Evaluable participants (treated participants who utilized symptomatic therapy during the overall treatment period [12 weeks]). | Posted | Mean | Standard Deviation | units on a scale | 12 Weeks |
|
|
| |||||||||||||||||||||||||
| Primary | Worst Severity Score of Overall GI Events, Modified Acute Gl Symptom Scale | Severity of GI-related events in DMF-treated participants using the MAGISS to measure GI symptoms, based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. | Evaluable participants (treated participants who utilized symptomatic therapy during the overall treatment period [12 weeks]). | Posted | Mean | Standard Deviation | units on a scale | 12 Weeks |
|
| ||||||||||||||||||||||||||
| Primary | Percentage of DMF-treated Participants Who Reported GI-related Symptoms and Who Utilized Symptomatic Therapy | Percentage of participants reporting GI symptoms on the MOGISS, by those who utilized symptomatic therapy. | Safety Population (participants who received at least 1 dose of DMF, recorded in diary data) | Posted | Number | percentage of participants | 12 Weeks |
|
| |||||||||||||||||||||||||||
| Primary | Duration of GI-related Episodes in DMF-treated Participants | In participants who took symptomatic therapy, the median duration of acute GI episodes (in hours) was summarized for the overall treatment period, by symptom (nausea, diarrhea, lower abdominal pain, upper abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence). Table only includes the symptom duration for those symptoms with start and stop times entered in the eDiary (evaluable GI episodes), based on the MAGISS. | Evaluable participants (treated participants who utilized symptomatic therapy during the overall treatment period [12 weeks]); n=number of participants with evaluable GI symptom specified. | Posted | Median | Full Range | hours | 12 Weeks |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of DMF-treated Participants Who Required GI Symptomatic Therapy | Percentage of participants reporting that they required GI symptomatic therapy, based on the MOGISS. | Safety Population (participants who received at least 1 dose of DMF, recorded in diary data) | Posted | Number | percentage of participants | 12 Weeks |
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| Secondary | Participants' Use of Symptomatic Therapy, by Type and Category | The symptomatic therapies used by DMF-treated participants were self-reported by type and category. Each participant may have taken more than one symptomatic therapy type but was counted only once within each therapy category. Acetylsalicylic acid (ASA) is abbreviated in the table. | Safety Population (participants who received at least 1 dose of DMF, recorded in diary data) | Posted | Number | participants | 12 Weeks |
|
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| Secondary | Summary of Use and Days on Symptomatic Therapy, by Category | The total duration (in days) of use of each symptomatic therapy by participants as a result of GI symptoms experienced by DMF-treated participants is presented. If a participant had multiple different therapies on the same day, the days on symptomatic therapy was calculated as 1 day in the 'All Therapies' category. | Evaluable participants (treated participants who utilized symptomatic therapy during the overall treatment period [12 weeks]). n= number of participants using the therapy specified. | Posted | Mean | Standard Deviation | days | 12 Weeks |
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| Secondary | Number of DMF-treated Participants Who Discontinued DMF Due to GI-related Events Requiring Symptomatic Therapy | The last symptomatic therapy prior to last dose of study medication was used to summarize the number of participants who discontinued DMF due to GI-related events. Participants may have taken more than one symptomatic therapy but are counted only once in the 'All Therapies' category. | Safety Population (participants who received at least 1 dose of DMF, recorded in diary data) | Posted | Number | participants | 12 Weeks |
|
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All serious adverse events (SAEs) from time of signed/dated informed consent through 12 weeks of treatment plus 4 weeks (± 5 days) post last dose.
Non-serious adverse events (other than GI-related events and events resulting in discontinuation of the study drug or withdrawal from the study) were not collected in this study, per protocol.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dimethyl Fumarate | 120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal). | 7 | 233 | 0 | 233 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Salivary Gland Calculus | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
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| Sudden Cardiac Death | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Troponin Increased | Investigations | MedDRA 16.1 | Systematic Assessment |
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| Pain In Jaw | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Confusional State | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
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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 Idec Study Medical Director | Biogen Idec | clinicaltrials@biogenidec.com |
| ID | Term |
|---|---|
| D000069462 | Dimethyl Fumarate |
| ID | Term |
|---|---|
| D005650 | Fumarates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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