DIROXIMEL FUMARATE TO REDUCE PERIHAEMATOMAL OEDEMA IN INTRACEREBRAL HAEMORRHAGE: A DOUBLE BLIND RANDOMIZED CLINICAL TRIAL (DARLENE)

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-522687-33-00

Enrollment

192

Registered

2026-02-26

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Brief summary

Absolute volume of PHO assessed at 8 ± 1 days with brain non-contrast CT (NCCT) scan.

Detailed description

Functional outcome: global disability assessed by overall distribution of mRS score at 6 months (end of follow-up) (shift analysis), Safety outcome: The rate of severe adverse events (see chapter 10 “Safety Assessment”) occurring between the date of randomization and the end of follow-up (six-month visit).

Interventions

DRUGVumerity 231 mg gastro-resistant hard capsules

DRUGVumerity Placebo. Le placebo utilisé aura les mêmes caractéristiques que le traitement à l'étude (Vumerity 231 mg) sur son aspect visuel

DRUGson goût et sa forme

DRUGsans la molécule active. Il sera fourni par la société Synerlab Development.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Absolute volume of PHO assessed at 8 ± 1 days with brain non-contrast CT (NCCT) scan.	—

Secondary

Measure	Time frame
Functional outcome: global disability assessed by overall distribution of mRS score at 6 months (end of follow-up) (shift analysis), Safety outcome: The rate of severe adverse events (see chapter 10 “Safety Assessment”) occurring between the date of randomization and the end of follow-up (six-month visit).	—

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 27, 2026