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Efficacy of prophylactic levetiracetam for improving functional outcome in the acute phase of intracerebral haemorrhage: a randomised, double-blind, placebo-controlled, phase 3 trial PEACH 2
EU CTIS ID: 2024-515663-59-00
What this study is testing
to establish if primary prophylactic antiseizure drug improves functional outcome at 6 months in patients with ICH.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - Age ≥ 18 years
- Spontaneous (non-traumatic) supratentorial intracerebral haemorrhage diagnosed by brain CT or MRI
- Onset of neurologic symptoms within 24 hours
- NIHSS score on admission ≤ 25
- Informed consent given by the patient or his/her impartial witness
- Patients benefiting from a social insurance system or a similar system
You likely can't join if
- Intracerebral haemorrhage known or suspected by study investigator to be secondary to trauma, vascular malformation, haemorrhagic transformation of ischaemic stroke, or cerebral tumour
- Patients with inaugural seizures at the onset of symptoms associated with intracerebral hemorrhage
- Patients with QTc prolongation
- 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
- Patients taking probenecid, methotrexate or macrogol
- Current use of antiseizure drugs or history of epilepsy
See the full eligibility criteria
- - Age ≥ 18 years
- Spontaneous (non-traumatic) supratentorial intracerebral haemorrhage diagnosed by brain CT or MRI
- Onset of neurologic symptoms within 24 hours
- NIHSS score on admission ≤ 25
- Informed consent given by the patient or his/her impartial witness
- Patients benefiting from a social insurance system or a similar system
- Intracerebral haemorrhage known or suspected by study investigator to be secondary to trauma, vascular malformation, haemorrhagic transformation of ischaemic stroke, or cerebral tumour
- Patients with inaugural seizures at the onset of symptoms associated with intracerebral hemorrhage
- Patients with QTc prolongation
- 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
- Patients taking probenecid, methotrexate or macrogol
- Current use of antiseizure drugs or history of epilepsy
- Severe renal insufficiency (creatinine clearance < 30 ml/min)
- Pregnancy or breastfeeding
- Previous history of severe depression, or psychotic disorder or suicidal attempt
- - Known terminal illness
- Known allergy or hypersensitivity to Levetiracetam or other pyrrolidone derivatives, or any of the excipients.
- Known allergy or hypersensitivity to microcrystalline cellulose or lactose
- Being under legal protection
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.