Tecfidera and the Gut Microbiota

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-06

Study Completion Date

2017-06-12

Brief Summary

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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.

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Detailed Description

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Conditions

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Multiple Sclerosis, Relapsing-Remitting

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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dimethyl fumarate

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

Group Type EXPERIMENTAL

dimethyl fumarate

Intervention Type DRUG

As per the prevailing local label.

injectable MS DMT

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

Group Type ACTIVE_COMPARATOR

injectable MS DMT

Intervention Type DRUG

As described above.

Interventions

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dimethyl fumarate

As per the prevailing local label.

Intervention Type DRUG

injectable MS DMT

As described above.

Intervention Type DRUG

Other Intervention Names

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DMF Tecfidera BG00012

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No