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CompletedPhase 4

Tecfidera and the Gut Microbiota

NCT02471560 · TECONGUT · Biogen

Closed to entry
Status
Not accepting participants
Phase 4
Phase
36
Target enrolment
7
Study sites
Outside the US

What it is testing

Summary

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Comparison of the change in gut microbiota composition in participants pre vs. post initiation of DMF treatment.

    Measured over Day 1, Week 2, Week 12 and/or upon occurrence of GI symptoms outside of designated time points

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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.

Where

7 study sites

FacilityCityRegionCountry
Research siteDrammen—Norway
Research siteHaukeland—Norway
Research SiteLillehammer—Norway
Research siteLørenskog—Norway
Research siteMolde—Norway
Research siteOslo—Norway
Research siteStavanger—Norway

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT02471560 on ClinicalTrials.gov →

Last updated in the registry 2021-09-05. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

All 2 trials from Biogen →