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

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ClinicalTrials.gov Identifier: NCT01873417
Recruitment Status : Completed
First Posted : June 10, 2013
Results First Posted : November 11, 2014
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Biogen

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.

Condition or disease Intervention/treatment Phase
Relapsing Forms of Multiple Sclerosis Drug: BG00012 (DMF) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 237 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dimethyl Fumarate
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).
Drug: BG00012 (DMF)
Other Names:
  • Tecfidera
  • DMF
  • dimethyl fumarate




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01873417


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Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen

Publications:
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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01873417     History of Changes
Other Study ID Numbers: 109MS403
First Posted: June 10, 2013    Key Record Dates
Results First Posted: November 11, 2014
Last Update Posted: March 21, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Dimethyl Fumarate
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs