Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Tecfidera and the Gut Microbiota (TECONGUT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02471560
Recruitment Status : Completed
First Posted : June 15, 2015
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Biogen

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Relapsing-Remitting Drug: dimethyl fumarate Drug: injectable MS DMT Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Effect of Tecfidera® (Dimethyl Fumarate, BG00012) on the Gut Microbiota as a Causal Factor for Gastro Intestinal Associated Adverse Events.
Actual Study Start Date : November 30, 2015
Actual Primary Completion Date : June 12, 2017
Actual Study Completion Date : June 12, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: dimethyl fumarate
As prescribed by the Investigator according to the local Summary of Product Characteristics.
Drug: dimethyl fumarate
As per the prevailing local label.
Other Names:
  • DMF
  • Tecfidera
  • BG00012

Active Comparator: injectable MS DMT
As prescribed by the Investigator according to the local Summary of Product Characteristics.
Drug: injectable MS DMT
As described above.




Primary Outcome Measures :
  1. Comparison of the change in gut microbiota composition in participants pre vs. post initiation of DMF treatment. [ Time Frame: Day 1, Week 2, Week 12 and/or upon occurrence of GI symptoms outside of designated time points ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: Day 1, Week 2, Week 12 and/or upon occurrence of GI symptoms outside of designated time points ]
    GSRS is a self-reported questionnaire regarding GI symptoms comprising 15 items scored on a 7-point Likert scale. The 15 items can be grouped in 5 dimensions 1) abdominal pain (abdominal pain, gastric hunger pain, and nausea) 2) reflux (heartburn and acid regurgitation) 3) indigestion (borborygmus, bloating, eructation, and increased flatus) 4) diarrhea (diarrhea, loose stools, and urgency) and 5) constipation (constipation, hard stools, incomplete evacuation). A GI AE will be defined as an at least 2 point (>=2) increase from baseline in total score of any of the 5 dimensions in the GSRS.

  2. 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) [ Time Frame: Day 1, Week 2, Week 12 and/or upon occurrence of GI symptoms outside of designated time points ]
  3. Baseline differences in the gut microbiota composition between DMF treated participants that do or do not develop GI AEs. [ Time Frame: Day 1, Week 2, Week 12 and/or upon occurrence of GI symptoms outside of designated time points ]
  4. Changes in the gut microbiota composition of DMF treated participants after resolution of GI AEs vs. during GI AE occurrences. [ Time Frame: Upon GI symptoms and week 12 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02471560


Locations
Layout table for location information
Norway
Research site
Drammen, Norway, 3019
Research site
Haukeland, Norway, 5021
Research Site
Lillehammer, Norway, 2609
Research site
Lørenskog, Norway, 1478
Research site
Molde, Norway, 6412
Research site
Oslo, Norway, 0450
Research site
Stavanger, Norway, 4011
Sponsors and Collaborators
Biogen
Investigators
Layout table for investigator information
Study Director: Medical Director Biogen
Layout table for additonal information
Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02471560    
Other Study ID Numbers: NOR-BGT-14-10665
2015-001197-18 ( EudraCT Number )
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Biogen:
Microbiota
DMF
Gastro intestinal
MS
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Dimethyl Fumarate
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs