Phase 4 Gastrointestinal Tolerability Study of Dimethyl Fumarate in Patients With Relapsing Forms of Multiple Sclerosis in the United States
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Official title
A Multicenter, Open-Label, Single-Arm Study of Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving Tecfidera™ (Dimethyl Fumarate) Delayed-release Capsules
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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: * To evaluate GI-related events requiring symptomatic therapy and the role of those therapies over time in participants with relapsing forms of MS initiating therapy with DMF in the clinical practice setting. * To evaluate GI-related events that lead to DMF discontinuation after the use of symptomatic therapy in participants with relapsing forms of MS initiating therapy with DMF in the clinical practice setting.
Study identification
- NCT ID
- NCT01873417
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 237 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 2013 (Type not available)
- Primary completion
- Nov 2013 (Actual)
- Completion
- Nov 2013 (Actual)
- Last update posted
- Mar 21, 2017
2013
United States locations
- U.S. sites
- 37
- U.S. states
- 21
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Cullman | Alabama | 35058 | — |
| Research Site | Gilbert | Arizona | 85234 | — |
| Research Site | Scottsdale | Arizona | 85258 | — |
| Research Site | Fullerton | California | 92835 | — |
| Research Site | Newport Beach | California | 92663 | — |
| Research Site | Pasadena | California | 91105 | — |
| Research Site | Englewood | Colorado | 80113 | — |
| Research Site | Fort Collins | Colorado | 80528 | — |
| Research Site | Danbury | Connecticut | 06810 | — |
| Research Site | Maitland | Florida | 32751 | — |
| Research Site | Naples | Florida | 34102 | — |
| Research Site | North Palm Beach | Florida | 33408 | — |
| Research Site | Port Charlotte | Florida | 33952 | — |
| Research Site | Sarasota | Florida | 34239 | — |
| Research Site | St. Petersburg | Florida | 33713 | — |
| Research Site | Tampa | Florida | 33609 | — |
| Research Site | Tampa | Florida | 33612 | — |
| Research Site | Atlanta | Georgia | 30327 | — |
| Research Site | Indianapolis | Indiana | 46256 | — |
| Research Site | Milford | Massachusetts | 01757 | — |
| Research Site | Golden Valley | Minnesota | 55422 | — |
| Research Site | Patchogue | New York | 11772 | — |
| Research Site | Charlotte | North Carolina | 28204 | — |
| Research Site | Greensboro | North Carolina | 27405 | — |
| Research Site | High Point | North Carolina | 27262 | — |
| Research Site | Fargo | North Dakota | 58103 | — |
| Research Site | Portland | Oregon | 97225 | — |
| Research Site | Monroeville | Pennsylvania | 15215 | — |
| Research Site | Cordova | Tennessee | 38018 | — |
| Research Site | Franklin | Tennessee | 37064 | — |
| Research Site | Knoxville | Tennessee | 37934 | — |
| Research Site | Round Rock | Texas | 78681 | — |
| Research Site | Salt Lake City | Utah | 84103 | — |
| Research Site | Richmond | Virginia | 23298 | — |
| Research Site | Roanoke | Virginia | 24018 | — |
| Research Site | Tacoma | Washington | 98405 | — |
| Research Site | Milwaukee | Wisconsin | 53215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01873417, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 21, 2017 · Synced Nov 14, 2026
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