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Completed

NCT Number: NCT01873417

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

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.

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Key information

Conditions

Relapsing Forms of Multiple Sclerosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site, Cullman, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BG00012 (DMF)

Drug

Other names: Tecfidera, DMF, dimethyl fumarate

Primary outcomes

  1. Worst Severity Score of Overall Gastrointestinal (GI) Events, Modified Overall GI Symptom Scale (MOGISS)

    Time frame: 12 Weeks

    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.

  2. Worst Severity Score of Overall GI Events, Modified Acute Gl Symptom Scale

    Time frame: 12 Weeks

    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.

  3. Percentage of DMF-treated Participants Who Reported GI-related Symptoms and Who Utilized Symptomatic Therapy

    Time frame: 12 Weeks

    Percentage of participants reporting GI symptoms on the MOGISS, by those who utilized symptomatic therapy.

  4. Duration of GI-related Episodes in DMF-treated Participants

    Time frame: 12 Weeks

    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.

Secondary outcomes

  1. Percentage of DMF-treated Participants Who Required GI Symptomatic Therapy

    Time frame: 12 Weeks

    Percentage of participants reporting that they required GI symptomatic therapy, based on the MOGISS.

  2. Participants' Use of Symptomatic Therapy, by Type and Category

    Time frame: 12 Weeks

    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.

  3. Summary of Use and Days on Symptomatic Therapy, by Category

    Time frame: 12 Weeks

    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.

  4. Number of DMF-treated Participants Who Discontinued DMF Due to GI-related Events Requiring Symptomatic Therapy

    Time frame: 12 Weeks

    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.

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study 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

Acronym: MANAGE

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 10, 2013
Registry last updated
Mar 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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