Phase 4 Gastrointestinal Tolerability Study of Dimethyl Fumarate in Patients With Relapsing Forms of Multiple Sclerosis in the United States
MANAGE
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
1 other identifier
interventional
237
1 country
37
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2013
Shorter than P25 for phase_4
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 9, 2013
CompletedFirst Posted
Study publicly available on registry
June 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedResults Posted
Study results publicly available
November 11, 2014
CompletedMarch 21, 2017
February 1, 2017
6 months
May 9, 2013
November 4, 2014
February 14, 2017
Conditions
Outcome Measures
Primary Outcomes (4)
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
Secondary Outcomes (4)
Percentage of DMF-treated Participants Who Required GI Symptomatic Therapy
12 Weeks
Participants' Use of Symptomatic Therapy, by Type and Category
12 Weeks
Summary of Use and Days on Symptomatic Therapy, by Category
12 Weeks
Number of DMF-treated Participants Who Discontinued DMF Due to GI-related Events Requiring Symptomatic Therapy
12 Weeks
Study Arms (1)
Dimethyl Fumarate
EXPERIMENTAL120 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).
Interventions
Eligibility Criteria
You may qualify if:
- Decision to treat with DMF must precede enrollment.
- Naïve to DMF or fumaric acid esters.
- Resides in the US and has a confirmed diagnosis of a relapsing form of MS.
- Satisfies the approved therapeutic indication(s) for DMF.
You may not qualify if:
- Inability to comply with study requirements or, at the discretion of the Investigator, is deemed unsuitable for study participation.
- History of significant GI disease, chronic use of GI symptomatic therapy, active malignancies.
- Is participating in any other interventional clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (37)
Research Site
Cullman, Alabama, 35058, United States
Research Site
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
Related Publications (1)
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.
PMID: 26917993BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Biogen Idec Study Medical Director
- Organization
- Biogen Idec
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2013
First Posted
June 10, 2013
Study Start
May 1, 2013
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
March 21, 2017
Results First Posted
November 11, 2014
Record last verified: 2017-02