E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
adult patients with relapsing remitting multiple sclerosis |
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E.1.1.2 | Therapeutic area | Diseases [C] - Injuries, poisonings, and occupational diseases [C21] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of the study is to determine if DMF causes changes in the commensal microbiota. |
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E.2.2 | Secondary objectives of the trial |
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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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Have a confirmed diagnosis of RRMS and satisfy the therapeutic indication as described in the local label. |
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
To study the effect of dimetyl fumarate on the gut microbiota |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 0 |