Tecfidera and the Gut Microbiota (TECONGUT)

Biogen

Status and phase: Completed; Phase 4

Conditions: Multiple Sclerosis, Relapsing-Remitting

Treatments: Drug: injectable MS DMT; Drug: dimethyl fumarate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02471560

NOR-BGT-14-10665

2015-001197-18 (EudraCT Number)

Details and patient eligibility

About

The primary objective of the study is to determine if dimethyl fumarate (DMF) causes changes in the abundance and diversity of commensal microbiota. The secondary objectives of this study are as follows: To identify if there are differences in the gut microbiota composition between patients that do or do not develop gastro intestinal (GI) adverse events (AEs), both pre- and post DMF treatment and to examine if the resolution of GI AEs in DMF treated patients is reflected in the gut microbiota.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Have a confirmed diagnosis of RRMS and satisfy the therapeutic indication as described in the local label.
• Female subjects of childbearing potential who are not surgically sterile must practice effective contraception according to the summary of product characteristics (SPC) during their participation in the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.

Key Exclusion Criteria:

• Diagnosis of primary progressive, secondary progressive or progressive relapsing MS.
• Antibiotic treatment in the last month prior to study entry.
• Scheduled alteration of diet, including the use of probiotics.

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

dimethyl fumarate

Experimental group

Description:

As prescribed by the Investigator according to the local Summary of Product Characteristics.

Treatment:

Drug: dimethyl fumarate

injectable MS DMT

Active Comparator group

Description:

As prescribed by the Investigator according to the local Summary of Product Characteristics.

Treatment:

Drug: injectable MS DMT