MRI Trial to exPlore the efficAcy and Safety of IMU-838 in Relapsing Remitting Multiple Sclerosis (EMPhASIS)
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Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
210actual
Sites
38
Countries
Bulgaria, Poland, Romania +1
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2019-01-28 | actual | When the study began enrolling |
| Primary completion | 2020-04-24 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2029 | estimated | The whole study's end, after follow-up |
| First posted | 2019-02-19 | actual | When this record first appeared on the registry |
| Results posted | 2021-07-23 | actual | When the sponsor posted results to the registry |
| Record updated | 2024-04-24 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Relapsing-Remitting Multiple Sclerosis (RRMS)
Interventions
- Drug: IMU-838 (30 mg/day) — also filed as Vidofludimus Calcium, Oral Tablet (30 mg/day)
- Drug: IMU-838 (45 mg/day) — also filed as Vidofludimus Calcium, Oral Tablet (45 mg/day)
- Drug: Placebo
- Drug: IMU-838 (10 mg/day) — also filed as Vidofludimus Calcium, Oral Tablet (10 mg/day)
Primary outcome
what the primary-completion date above is the date OFDifference Between 45 mg/Day IMU-838 and Placebo in the Cumulative Number of Combined Unique Active (CUA) MRI Lesions
measured Up to Week 24
Posted documents
hosted by the registry — we link, never re-serveStudy Protocol and Statistical Analysis Planposted 2020-08-28 · 2.2 MB · Prot_SAP_000.pdf
Publications
- PMID 38662979 — linked by the registry
- PMID 35698927 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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