Phase 2 Stroke Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 or older, with no upper age limit
• People admitted to hospital for a brain bleed (known as an intracerebral haemorrhage, or ICH) in a specific part of the brain (the upper brain, not the brainstem), confirmed by brain scans — this includes a first-ever bleed or a repeat bleed that happened more than 1 year ago
• People for whom the study treatment can be started within 48 hours of symptoms beginning, or within 48 hours of when the person was last seen to be well
• People who have given written consent to take part
• People who have social insurance in France
• People who are willing and able to follow all study procedures for the full duration of the trial

Who may not be able to join:

• People whose brain bleed is very large (estimated at more than 60ml), where treatment is considered unlikely to help
• People in a very deep state of unconsciousness (a score below 6 on a standard medical scale called the Glasgow Coma Scale)
• People whose bleeding is confined entirely to the fluid-filled spaces inside the brain (the ventricles), with no bleed in the brain tissue itself
• People whose brain bleed is thought to have been caused by a head injury, an abnormal blood vessel in the brain, a blood clot in a brain vein, a tumour, or bleeding that developed from a stroke
• People who are already scheduled for surgery to remove the blood clot before being enrolled in the trial (including drainage, skull surgery, or a drain placed into the brain)
• People who are already being treated with the study drug (diroximel fumarate, or DRF) or a similar medication (such as dimethyl fumarate/Tecfidera), for example for multiple sclerosis
• People who have a known allergy or sensitivity to the study drug (DRF) or to any of its ingredients, or to dimethyl fumarate
• People who have a very low level of a particular type of white blood cell (lymphocytes) on admission
• People with a confirmed or suspected serious brain infection linked to a weakened immune system (progressive multifocal leukoencephalopathy)
• People with a severe difficulty swallowing, or who need a feeding tube through the nose
• People who were severely dependent in daily life before the brain bleed (a score of 5 on a standard disability scale, meaning fully dependent on others for all care)
• People with a life expectancy of less than 1 year due to other serious health conditions
• People with severe failure of a major organ, such as the heart, kidneys, or liver
• People for whom a decision has already been made to focus on comfort/end-of-life care only, with active treatments being withdrawn
• People who are pregnant, breastfeeding, or women of childbearing age for whom effective contraception is not in place (a pregnancy test will be carried out)
• People who are currently detained or imprisoned by a legal or government decision

Important: Always verify eligibility with the trial site directly before applying.