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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 April 2022 |
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Main ID: |
EUCTR2015-001197-18-NO |
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Date of registration:
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15/04/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The effect of Tecfidera® (Dimethyl Fumarate) on the gut microbiota as a causal factor for GI associated adverse events.
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Scientific title:
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The effect of Tecfidera® (Dimethyl Fumarate) on the gut microbiota as a causal factor for GI associated adverse events. |
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Date of first enrolment:
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20/05/2015 |
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Target sample size:
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70 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-001197-18 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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Norway
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Contacts
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Name:
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Medical Director
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Address:
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Vitaminveien 1A
0485
Oslo
Norway |
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Telephone:
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4723400100 |
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Email:
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medinfo.norway@biogenidec.com |
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Affiliation:
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Biogen Idec Norway |
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Name:
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Medical Director
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Address:
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Vitaminveien 1A
0485
Oslo
Norway |
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Telephone:
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4723400100 |
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Email:
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medinfo.norway@biogenidec.com |
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Affiliation:
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Biogen Idec Norway |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Have a confirmed diagnosis of RRMS and satisfy the therapeutic indication as described in the local label.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 65
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
Exclusion criteria:
Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS.
History of malignancy (except for basal cell carcinoma that had been completely excised prior to study entry), severe allergic or anaphylactic reactions or known drug hypersensitivity, abnormal laboratory results indicative of any significant disease, and/or a major disease that would preclude participation in a clinical trial.
Antibiotic treatment in the last month prior to study entry
Scheduled alteration of diet, including the use of probiotics.
The following gastrointestinal conditions: ongoing GI infection, known inflammatory bowel disease, previous intestinal surgery (resections, stoma etc).
6. Previously treated with teriflunomide, fingolimod, natalizumab, or alemtuzumab, or medication that potentially could affect the gut microbiota.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]
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multiple sclerosis
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Intervention(s)
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Trade Name: Tecfidera
Product Name: Tecfidera
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: DIMETHYL FUMARATE
CAS Number: 624-49-7
Other descriptive name: DIMETHYL FUMARATE
Concentration unit: IU/mg international unit(s)/milligram
Concentration type: range
Concentration number: 240-480
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Primary Outcome(s)
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Timepoint(s) of evaluation of this end point: At week 2 and at week 12
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Main Objective: The primary objective of the study is to determine if DMF causes changes in the commensal microbiota.
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Secondary Objective: To identify if there are differences in the gut microbiota composition between patients that do or do not develop GI AEs, both pre- and post DMF treatment.
To examine if the resolution of GI symptoms in DMF treated patients is reflected in the gut microbiota.
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Primary end point(s): The primary endpoint of this study is changes in gut microbiota composition (alpha diversity, beta diversity, abundances of bacterial taxa on all taxonomic levels) in subjects pre vs. post DMF administration.
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: Week 2 and week 12
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Secondary end point(s): The secondary endpoints for this study are as follows:
• Changes in the gut microbiota composition (alpha diversity, beta diversity, abundances of bacterial taxa on all taxonomic levels) between DMF treated patients that do or do not develop GI AEs.
Changes in gut microbiota composition (alpha diversity, beta diversity, abundances of bacterial taxa on all taxonomic levels) in subjects treated with DMF compared to patients treated with an alternative injectable MS DMT.
Baseline differences in the gut microbiota composition (alpha diversity, beta diversity, abundances of bacterial taxa on all taxonomic levels) between DMF treated patients that do or do not develop GI AEs.
Changes in the gut microbiota composition (alpha diversity, beta diversity, abundances of bacterial taxa on all taxonomic levels) of DMF treated patients after resolution of GI AEs vs. during GI AE occurrences.
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Secondary ID(s)
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NOR-BGT-14-10665
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Source(s) of Monetary Support
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Biogen Idec Norway
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Ethics review
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Status: Approved
Approval date: 20/05/2015
Contact:
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