Phase 4 Gastrointestinal Tolerability Study of Dimethyl Fumarate in Patients With Relapsing Forms of Multiple Sclerosis in the United States

Relapsing Forms of Multiple Sclerosis Clinical Trial

— MANAGE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01873417
• Other study ID #: 109MS403
• Status: Completed
• Phase: Phase 4
• First received: May 9, 2013
• Last updated: November 4, 2014
• Start date: May 2013
• Est. completion date: November 2013

Study information

• Verified date: November 2014
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• 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.

Key Exclusion Criteria:

• 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.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Relapsing Forms of Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• BG00012 (DMF)

Locations

Country	Name	City	State
United States	Research Site	Atlanta	Georgia
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Cordova	Tennessee
United States	Research Site	Cullman	Alabama
United States	Research Site	Danbury	Connecticut
United States	Research Site	Englewood	Colorado
United States	Research Site	Fargo	North Dakota
United States	Research Site	Fort Collins	Colorado
United States	Research Site	Franklin	Tennessee
United States	Research Site	Fullerton	California
United States	Research Site	Gilbert	Arizona
United States	Research Site	Golden Valley	Minnesota
United States	Research Site	Greensboro	North Carolina
United States	Research Site	High Point	North Carolina
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Knoxville	Tennessee
United States	Research Site	Maitland	Florida
United States	Research Site	Milford	Massachusetts
United States	Research Site	Milwaukee	Wisconsin
United States	Research Site	Monroeville	Pennsylvania
United States	Research Site	Naples	Florida
United States	Research Site	Newport Beach	California
United States	Research Site	North Palm Beach	Florida
United States	Research Site	Pasadena	California
United States	Research Site	Patchogue	New York
United States	Research Site	Port Charlotte	Florida
United States	Research Site	Portland	Oregon
United States	Research Site	Richmond	Virginia
United States	Research Site	Roanoke	Virginia
United States	Research Site	Round Rock	Texas
United States	Research Site	Salt Lake City	Utah
United States	Research Site	Sarasota	Florida
United States	Research Site	Scottsdale	Arizona
United States	Research Site	St. Petersburg	Florida
United States	Research Site	Tacoma	Washington
United States	Research Site	Tampa	Florida
United States	Research Site	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	12 Weeks	Yes
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.	12 Weeks	Yes
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.	12 Weeks	Yes
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.	12 Weeks	Yes
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.	12 Weeks	Yes
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.	12 Weeks	Yes
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.	12 Weeks	Yes
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.	12 Weeks	Yes