A Phase 4 interventional study of dimethyl fumarate and injectable MS DMT in Multiple Sclerosis, Relapsing-Remitting, sponsored by Biogen. Completed at 7 sites in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-05.
Sponsored by Biogen · Phase 4, Interventional, and Other
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 36 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
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Of its 98 completed or terminated interventional studies of FDA-regulated products, 49 (50%) have results posted.
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined inclusion/exclusion criteria may apply.
As prescribed by the Investigator according to the local Summary of Product Characteristics.
Drug: dimethyl fumarate
As prescribed by the Investigator according to the local Summary of Product Characteristics.
Drug: injectable MS DMT
As per the prevailing local label.
Also known as: DMF, Tecfidera, BG00012
As described above.
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
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.
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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: Upon GI symptoms and week 12
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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