Levetiracetam for Intracerebral haemorrhage

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years\n- Spontaneous (non-traumatic) supratentorial intracerebral haemorrhage diagnosed by brain CT or MRI\n- Onset of neurologic symptoms within 24 hours\n- NIHSS score on admission ≤ 25\n- Informed consent given by the patient or his/her impartial witness\n- Patients benefiting from a social insurance system or a similar system"}

Exclusion criteria

• {"criterion_text":"- Intracerebral haemorrhage known or suspected by study investigator to be secondary to trauma, vascular malformation, haemorrhagic transformation of ischaemic stroke, or cerebral tumour\n- Current use of antiseizure drugs or history of epilepsy\n- Severe renal insufficiency (creatinine clearance < 30 ml/min)\n- Pregnancy or breastfeeding\n- Previous history of severe depression, or psychotic disorder or suicidal attempt\n- - Known terminal illness\n- Known allergy or hypersensitivity to Levetiracetam or other pyrrolidone derivatives, or any of the excipients.\n- Known allergy or hypersensitivity to microcrystalline cellulose or lactose\n- Being under legal protection\n- Patients with inaugural seizures at the onset of symptoms associated with intracerebral hemorrhage\n- Patients with QTc prolongation\n- Patients who have been part of a clinical study involving another investigational product in the previous 30 days or within 5 half-lives of the other investigational product prior to Screening, whichever is longer, or participant is currently receiving an investigational product\n- Patients taking probenecid, methotrexate or macrogol"}

Primary endpoints

• {"endpoint_text":"- Functional status (death or dependency) at 6 months will be measured by the modified Rankin Scale (mRS), using ordinal logistic regression, adjusted for the stratification criterion. The mRS score will be measured during a face-to-face or remotely (if needed because of patients’ clinical status) with a standardised guided interview by a certified stroke neurologist or a certified clinical research associate (only remotely) at the 6 month-follow up visit, blinded to the patient study group.","definition_or_measurement_approach":"Measured by the modified Rankin Scale (mRS) at 6 months; analysis using ordinal logistic regression adjusted for the stratification criterion. mRS assessed face-to-face or remotely with a standardised guided interview by a certified stroke neurologist or a certified clinical research associate (remote assessments only), blinded to treatment allocation."}

Secondary endpoints

• {"endpoint_text":"- number of clinical seizures within 72 h and at 1, 6 and 12 months","definition_or_measurement_approach":"Count of clinical seizures assessed at 72 hours and at 1, 6 and 12 months"}
• {"endpoint_text":"- change in National Institute of Health Stroke Scale (NIHSS, 11 items version) score between inclusion and 72 h and 6 months.","definition_or_measurement_approach":"Change in NIHSS (11-item) from baseline to 72 hours and to 6 months"}
• {"endpoint_text":"- cognitive impairment assessed by the Montreal Cognitive Assessment (MoCA) version 8.3 at 6 months.","definition_or_measurement_approach":"MoCA v8.3 score at 6 months"}
• {"endpoint_text":"- Cognitive complaint assessed by the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) version 3 at 6 months.","definition_or_measurement_approach":"FACT-Cog v3 scores (four subscales) at 6 months"}
• {"endpoint_text":"- Quality of life assessed by the EuroQol - 5D-5L (EQ-5D-5L) at 6 and 12 months.","definition_or_measurement_approach":"EQ-5D-5L dimension scores, VAS and utility score at 6 and 12 months"}
• {"endpoint_text":"- modified Rankin Scale (mRS) score at 12 months","definition_or_measurement_approach":"mRS assessed at 12 months"}
• {"endpoint_text":"- Change in intracerebral haemorrhage volume (cc) and mass effect (mm) defined as midline shift on control brain imaging at 72 hours","definition_or_measurement_approach":"Change in hemorrhage volume (cc) and midline shift (mm) on control brain imaging at 72 hours"}
• {"endpoint_text":"- Frequency of side effects related to treatment at 1 and 6 months","definition_or_measurement_approach":"Treatment-related adverse event frequency assessed at 1 and 6 months"}
• {"endpoint_text":"- Frequency of pneumonia at 1 month","definition_or_measurement_approach":"Incidence of pneumonia at 1 month"}
• {"endpoint_text":"- Frequency of delirium at 1 month","definition_or_measurement_approach":"Incidence of delirium at 1 month"}
• {"endpoint_text":"- anxiety and depression evaluated with the Hospital Anxiety and Depression Scale (HADS) at one and 6 months.","definition_or_measurement_approach":"HADS scores at 1 and 6 months"}
• {"endpoint_text":"- all-cause mortality at 1, 6 and 12 months","definition_or_measurement_approach":"All-cause mortality rates assessed at 1, 6 and 12 months"}

France

Earliest CTIS Part Ii Submission Date

13-03-2026

Latest Decision Or Authorization Date

02-04-2026

Processing Time Days

20

Number Of Sites

15

Number Of Participants

580

Primary sponsor

Full Name

Hospices Civils De Lyon

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France