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

Biogen

Status and phase: Completed; Phase 4

Conditions: Relapsing Forms of Multiple Sclerosis

Treatments: Drug: BG00012 (DMF)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01873417

109MS403

Details and patient eligibility

About

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.

Enrollment: 237 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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237 participants in 1 patient group

Dimethyl Fumarate

Experimental group

Description:

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).

Treatment:

Drug: BG00012 (DMF)