2025-522687-33-00招募中3 期
DIROXIMEL FUMARATE TO REDUCE PERIHAEMATOMAL OEDEMA IN INTRACEREBRAL HAEMORRHAGE: A DOUBLE BLIND RANDOMIZED CLINICAL TRIAL (DARLENE)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 192
- 试验地点
- 9
- 主要终点
- Absolute volume of PHO assessed at 8 ± 1 days with brain non-contrast CT (NCCT) scan.
研究概览
简要总结
To demonstrate the efficacy of Diroximel Fumarate (DRF) as compared with placebo in reducing Peri-Haematoma Oedema (PHO) at day 8 in patients with spontaneous intracerebral haemorrhage (ICH).
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years or older (no upper age limit)
- •Patients admitted for a first-ever or recurrent symptomatic supratentorial spontaneous ICH confirmed by brain imaging
- •Administration of study treatment no later than 48 hours after symptom onset or since last seen without neurological deficit
- •Written consent obtained
- •Patient with social insurance in France
- •Patient willing to comply with all study procedures and duration
排除标准
- •Massive ICH for Investigational medicinal product seems futile (hematoma volume is estimated > 60ml)
- •Patients unable to swallow
- •Severe pre-ICH dependency (modified Rankin score of 5)
- •Life expectancy < 1 year related to comorbidities
- •Late-stage organ (acute cardiac, renal or hepatic failure)
- •Decision already taken for palliative (end of life) care with withdrawal of active treatment
- •Pregnancy or breastfeeding or Women of childbearing age without effective contraception (a pregnancy test will be done)
- •Adults who are deprived of their liberty by judicial or administrative decision
- •Severe coma (Glasgow Coma Scale <6)
- •Pure intraventricular hemorrhage
- •ICH suspected to result from a preceding trauma, an identified intracranial vascular malformation, venous thrombosis, tumor or hemorrhagic transformation within an infarct
- •Patient planned for surgical evacuation of ICH (Evacuation, Decompressive hemicraniectomy, External ventricular drain)
- •Patient with a known indication for DRF treatment (e.g. multiple sclerosis) or any other NrF2 agonist (dimethyl fumarate; Tecfidera)
- •Patient with contraindication to DRF: patients with known hypersensitivity to DRF, or to any of the excipients of VUMERITY; patients taking dimethyl fumarate)
- •Severe lymphopenia at admission (lymphocyte counts < 0.5 x 109/L)
- •Medical history of progressive multifocal leukoencephalopathy
结局指标
主要结局
Absolute volume of PHO assessed at 8 ± 1 days with brain non-contrast CT (NCCT) scan.
Absolute volume of PHO assessed at 8 ± 1 days with brain non-contrast CT (NCCT) scan.
次要结局
- 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).
研究者
Dr Lauren PUY
Scientific
Centre Hospitalier Universitaire De Lille
研究点 (9)
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