NCT02471560

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 15, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

November 6, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2017

Completed
Last Updated

September 5, 2021

Status Verified

September 1, 2021

Enrollment Period

1.6 years

First QC Date

June 11, 2015

Last Update Submit

September 3, 2021

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

MicrobiotaDMFGastro intestinalMS

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (4)

  • Change in gut microbiota composition between DMF treated participants that do or do not develop GI AEs as measured by an increase in the Gastrointestinal Symptom Rating Scale (GSRS) score.

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

  • Changes in gut microbiota composition in participants treated with DMF compared to participants treated with an alternative injectable multiple sclerosis (MS) disease modifying therapies (DMT)

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

  • Baseline differences in the gut microbiota composition between DMF treated participants that do or do not develop GI AEs.

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

  • Changes in the gut microbiota composition of DMF treated participants after resolution of GI AEs vs. during GI AE occurrences.

    Upon GI symptoms and week 12

Study Arms (2)

dimethyl fumarate

EXPERIMENTAL

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

Drug: dimethyl fumarate

injectable MS DMT

ACTIVE COMPARATOR

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

Drug: injectable MS DMT

Interventions

dimethyl fumarateDRUG

As per the prevailing local label.

Also known as: DMF, Tecfidera, BG00012
dimethyl fumarate
injectable MS DMTDRUG

As described above.

injectable MS DMT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Research site

Drammen, 3019, Norway

Location

Research site

Haukeland, 5021, Norway

Location

Research Site

Lillehammer, 2609, Norway

Location

Research site

Lørenskog, 1478, Norway

Location

Research site

Molde, 6412, Norway

Location

Research site

Oslo, 0450, Norway

Location

Research site

Stavanger, 4011, Norway

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Dimethyl Fumarate

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

FumaratesDicarboxylic AcidsAcids, AcyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Medical Director

    Biogen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2015

First Posted

June 15, 2015

Study Start

November 6, 2015

Primary Completion

June 12, 2017

Study Completion

June 12, 2017

Last Updated

September 5, 2021

Record last verified: 2021-09

Locations

NO(7)