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Clinical Trials in the EU / 2025-522687-33-00
Completed Phase III

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

2025-522687-33-00 · tracked via the Priya Life Science EU tracker
Sponsor
Centre Hospitalier Universitaire De Lille
Sponsor type
Hospital/Clinic/Other health care facility
Therapeutic area
Nervous System Diseases
Decision date
26/02/2026
Enrollment target
192
Sites
France

Condition studied

Stroke

Investigational medicinal product(s)

Vumerity 231 mg gastro-resistant hard capsulesVumerity Placebo. Le placebo utilisé aura les mêmes caractéristiques que le traitement à l'étude (Vumerity 231 mg) sur son aspect visuelson goût et sa formesans la molécule active. Il sera fourni par la société Synerlab Development.

Eligibility

Age group
18-64 years, 65+ years
Sex
Female, Male

Primary endpoint

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

Endpoint detail

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).

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-522687-33-00 on CTIS ↗ ← All trials in the EU