Spontaneous Intracerebral HemorrhagePhase 3PEACH2NCT07336992
Efficacy of Prophylactic Levetiracetam for Improving Functional Outcome in the Acute Phase of Intracerebral Haemorrhage: a Randomised, Double-blind, Placebo-controlled, Phase 3 Trial
A Phase 3 study testing Neuroimaging, National Institute of Health Stroke Scale (NIHSS) and Modified Rankin Scale (mRS) in people with Spontaneous Intracerebral Hemorrhage, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Epileptic seizures are a common complication at the acute phase of intracerebral haemorrhage (ICH). The incidence of seizures occurring within 7 days reaches 40% when subclinical seizures are diagnosed by continuous electroencephalogram (EEG). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spontaneous Intracerebral Hemorrhage
- What is being tested?
- Neuroimaging, National Institute of Health Stroke Scale (NIHSS) and Modified Rankin Scale (mRS)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 580 participants
- Where
- 1 siteFrance
- Study dates
- 2 Oct 2026to 2 Oct 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- For women of childbearing age, use of highly effective contraceptive method, which will be continued until the end of relevant systemic exposure of the treatment (i.e 56 hours after end of treatment).
Who cannot join
- Intracerebral haemorrhage known or suspected by study investigator to be secondary to trauma, vascular malformation, haemorrhagic transformation of ischaemic stroke, or tumour
- Current use of antiseizure drugs or history of epilepsy
- 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
- Severe renal insufficiency (creatinine clearance < 30 ml/min)
Show all 15Show fewer
- 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
- Patients taking probenecid, methotrexate or macrogol
- Being under legal protection
- Patients with seizures occurring between the inclusion of the patient and the start of the treatment
- Positive pregnancy test at inclusion for women of childbearing age
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hospices Civils de Lyon
Bron, 69500
Laurent DEREX, Dr, 04 72 35 78 09, laurent.derex@chu-lyon.fr
Nathalie Perreton, CP, 04 27 85 63 04, nathalie.perreton@chu-lyon.fr
About this study
Epileptic seizures are a common complication at the acute phase of intracerebral haemorrhage (ICH). The incidence of seizures occurring within 7 days reaches 40% when subclinical seizures are diagnosed by continuous electroencephalogram (EEG).
Some studies have suggested that early seizures are associated with haematoma expansion (Vespa., Neurology 2003), worse neurological outcomes (Gilmore., Stroke 2016) or increased mortality. By contrast, other studies have shown no association of acute seizures with long-term mortality and outcome. However, the interpretation of these works is subject to bias because almost all studies were based on clinical detection of seizures only, while it has been shown that most early seizures after ICH are clinically unrecognised and can only be diagnosed with EEG monitoring.
Read more
The PEACH trial, a double-blind, randomised, placebo-controlled, showed that clinical and/or electrographic seizures occur in more than 40% of patients with ICH and that Levetiracetam (LVT) is safe and effective in preventing these seizures. However, it remains unclear whether preventing acute seizures might lead to improved functional outcomes after ICH. An adequately powered randomised controlled trial is needed to answer whether primary seizure prophylaxis improves functional outcome in this setting. Answering this question would result in an important change in ICH acute care guidelines, which currently do not recommend primary prophylactic antiseizure treatment. As compared to research in acute ischemic stroke management, fewer clinical trials have been conducted in acute ICH and no effective medical treatments are available in this subset of patients.
The main objective of PEACH 2 is to establish if prophylactic antiseizure therapy with LVT improves functional outcome in adults with acute spontaneous ICH. Functional outcome assessed by the modified Rankin score (mRS score) six months after acute ICH will be compared between patients receiving prophylactic antiseizure therapy with levetiracetam and patients receiving placebo.
The secondary objectives are to examine the effect of prophylactic antiseizure therapy with levetiracetam versus placebo on:
- the number of early and late clinical seizures, on the short term and long term evolution of the neurologic deficit as assessed by the NIHSS, on long term functional outcome (12 months) as assessed by the mRS, on quality of life and cognitive impairment, and on haematoma expansion and mass effect on control brain imaging
- the frequency of side effects at 1 and 6 months, pneumonia at 1 month, delirium at 1 month, irritability/aggressivity, anxiety and depression at 1 and 6 months, and all-cause mortality at 1, 6 and 12 months. 580 patients will be recruited over 3 years.
- Conditions
- Spontaneous Intracerebral Hemorrhage
- Being tested
- Treatment administration (Levetiracetam or placebo), Neuroimaging, National Institute of Health Stroke Scale (NIHSS), Modified Rankin Scale (mRS), Euroqol test (EQ-5D-5L)
- Keywords
- supratentorial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment administration (Levetiracetam or placebo)Drug
Treatment should be initiated within 24 hours of randomisation. It will be administered intravenously for at least 48 hours and then the route of administration will be changed to oral administration at the same dosage after assessment of swallowing function. The treatment period will be 30 days at full dose, followed by a gradual tapering over 2 weeks.
NeuroimagingRadiation
Neuroimaging (brain CT or MRI) will be performed 72h post inclusion
National Institute of Health Stroke Scale (NIHSS)Diagnostic test
NIHSS, a clinician -reported 11-items stroke-specific severity scale, will be administered by a neurologist during all patients' study visits except at visits 1 month and 12 months.
Modified Rankin Scale (mRS)Behavioural
This questionnaire will be administered 3 time, at inclusion, 6 months and 12 months to measure post-stroke functional status and disability
Euroqol test (EQ-5D-5L)Behavioural
This self-reported questionnaire will be completed by patients at 6 and 12 months, to assess the multidimensional chronic consequences of stroke on their daily lives
Montreal Cognitive Assessment (MoCA)Behavioural
This test will be administered by a neurologist at 6 months to assess patients' cognitive impairment
Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog)Behavioural
This self-reported questionnaire will be completed by patients at 6 months, to assess patient's cognitive function (memory, attention, concentration, language, and thinking abilities)
Hospital Anxiety and Depression Scale (HADS)Behavioural
This questionnaire will be administered at 1 and 6 months to evaluate patients' anxiety and depression
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Active comparator | 290 patients will be recruited over 3 years in the intervention group.
In this group, Levetiracetam should be initiated within 24 hours of randomisation. Levetiracetam (500 mg every 12 hours) will be administered intravenously for at least 48 hours and then the route of administration will be changed to oral administration at the same dosage after assessment of swallowing function. The treatment period will be 30 days at full dose, followed by a gradual tapering over 2 weeks (250 mg of levetiracetam every 12 hours for 7 days, followed by 250 mg of levetiracetam every 24 h for 7 days). Receives: Drug: Treatment administration (Levetiracetam or placebo); Radiation: Neuroimaging; Diagnostic Test: National Institute of Health Stroke Scale (NIHSS); Behavioral: Modified Rankin Scale (mRS); Behavioral: Euroqol test (EQ-5D-5L); Behavioral: Montreal Cognitive Assessment (MoCA); Behavioral: Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog); Behavioral: Hospital Anxiety and Depression Scale (HADS) |
| Control Group | Placebo comparator | 290 patients will be recruited over 3 years in the control group.
In this group, the placebo (microcrystalline cellulose) should be initiated within 24 hours of randomisation. The placebo (500 mg every 12 hours) will be administered intravenously for at least 48 hours and then the route of administration will be changed to oral administration at the same dosage after assessment of swallowing function. The treatment period will be 30 days at full dose, followed by a gradual tapering over 2 weeks (250 mg of placebo every 12 hours for 7 days, followed by 250 mg of placebo every 24 h for 7 days). Receives: Drug: Treatment administration (Levetiracetam or placebo); Radiation: Neuroimaging; Diagnostic Test: National Institute of Health Stroke Scale (NIHSS); Behavioral: Modified Rankin Scale (mRS); Behavioral: Euroqol test (EQ-5D-5L); Behavioral: Montreal Cognitive Assessment (MoCA); Behavioral: Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog); Behavioral: Hospital Anxiety and Depression Scale (HADS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Rankin Scale (mRS) score to measure the functional status (death or dependency).
The mRS score will be measured by a certified neurologist, blinded to the patient study group.
It categorises disability with reference to pre-stroke activities. mRS is a single-item scale ranging from 0 (no disability) to 5 (severe disability) and 6 (death).
Its analysis will be performed by an ordinal logistic regression model with proportional odds and mixed effects. The treatment arm will be introduced in the model as fixed effect and the NIHSS score (≤ 15 vs >15) will be taken into account as a fixed effect. It will also take into account, as random effect, a random intercept by centre.
Measured: 6 and 12 months after inclusion
Secondary outcomes (26)
Number of clinical seizures
Measured: within 72 hours after inclusion
Number of clinical seizures
Measured: at 1 month after inclusion
Number of clinical seizures
Measured: at 6 months after inclusion
Number of clinical seizures
Measured: at 12 months after inclusion
Change in National Institute of Health Stroke Scale (NIHSS, 11 items version) score between inclusion and 72 h, and 6 months.
The NIHSS is a clinician -reported 11-items stroke-specific severity scale. This scale ranges from 0 to 42, with higher scores indicating greater severity
Measured: At inclusion
Change in National Institute of Health Stroke Scale (NIHSS, 11 items version) score between inclusion and 72 h, and 6 months.
The NIHSS is a clinician -reported 11-items stroke-specific severity scale. This scale ranges from 0 to 42, with higher scores indicating greater severity
Measured: At 72 hours
Change in National Institute of Health Stroke Scale (NIHSS, 11 items version) score between inclusion and 72 h, and 6 months.
The NIHSS is a clinician -reported 11-items stroke-specific severity scale. This scale ranges from 0 to 42, with higher scores indicating greater severity
Measured: At 6 months after inclusion
Change in modified Rankin Scale (mRS) score between inclusion and 6 months and 12 months
It categorises disability with reference to pre-stroke activities. mRS is a single-item scale ranging from 0 (no disability) to 5 (severe disability) and 6 (death).
Measured: At inclusion
Change in modified Rankin Scale (mRS) score between inclusion and 6 months and 12 months
It categorises disability with reference to pre-stroke activities. mRS is a single-item scale ranging from 0 (no disability) to 5 (severe disability) and 6 (death).
Measured: At 6 months after inclusion
Change in modified Rankin Scale (mRS) score between inclusion and 6 months and 12 months
It categorises disability with reference to pre-stroke activities. mRS is a single-item scale ranging from 0 (no disability) to 5 (severe disability) and 6 (death).
Measured: At 12 months after inclusion
Score at the Euroqol (EQ-5D-5L) to assess quality of life.
The EQ-5D-5L is a self-reported questionnaire composed of 5 items. The response to each item is based on a Likert scale rated from 1 (no difficulty) to 5 (inability), with a higher score reflecting worse autonomy. In addition, a question is asked about how the patients perceive their current health on a scale of 0 to 100.
An algorithm generates scores for each domain from 0 to 100, with a score of 0 corresponding to worse health and a score of 100 corresponding to greater health.
Measured: At 6 months
Score at the Euroqol (EQ-5D-5L) to assess quality of life.
The EQ-5D-5L is a self-reported questionnaire composed of 5 items. The response to each item is based on a Likert scale rated from 1 (no difficulty) to 5 (inability), with a higher score reflecting worse autonomy. In addition, a question is asked about how the patients perceive their current health on a scale of 0 to 100.
An algorithm generates scores for each domain from 0 to 100, with a score of 0 corresponding to worse health and a score of 100 corresponding to greater health.
Measured: At 12 months after inclusion
Score at the Montreal Cognitive Assessment (MoCA) version 8.3 to assess cognitive impairment.
This 30-point scale assesses visual-constructive functions, executive functions, short-term memory, attention, language, and temporo-spatial orientation. The score is pathological when it is strictly below 26/30.
Measured: 6 months after inclusion
Change in intracerebral haemorrhage volume (ml)
This change is defined as change in intracerebral haemorrhage volume between baseline brain imaging and control brain imaging at 72 hours
Measured: 72 hours after inclusion
Frequency of pneumonia
Measured: 1 month after inclusion
Frequency of side effects related to treatment
Measured: 1 month after inclusion
Frequency of side effects related to treatment
Measured: 6 months after inclusion
Frequency of delirium
Measured: 1 month after inclusion
Score at the Hospital Anxiety and Depression Scale (HADS) to assess anxiety and depression
This scale has 14 items scored from 0 to 3. Seven questions relate to anxiety and seven to depression, resulting in two scores with a maximum score of 21 for each. A score of 7 or less indicates no symptomatology, 8 to 10: doubtful symptomatology, and 11 and above: definite symptomatology.
Measured: At 6 months after inclusion
Death rate
Measured: At 1 month after inclusion
Death rate
Measured: At 6 months after inclusion
Death rate
Measured: At 12 months after inclusion
Score at the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)
This scale is a self-report questionnaire composed of 37-item assesses memory, attention, concentration, language, and thinking abilities. The FACT-Cog takes into consideration the functional implications of cognitive impairment, the deficits observed by other people, the changes in cognitive function over time, and their impact on the patient's quality of life. Scoring for the FACT-Cog includes calculation of four subscales based on a 5-point Likert scale (from never/not at all (0) to several times a day/very much) : Perceived Cognitive Impairment (20 items; score range 0-80), Impact On Quality Of Life (4 items; score range 0-16), Comments From Others (4 items; score range 0-16), and Perceived Cognitive Abilities (9 items; score range 0-36). The higher the score is, the better the quality of life is.
Measured: At 1 month after inclusion
Score at the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)
This scale is a self-report questionnaire composed of 37-item assesses memory, attention, concentration, language, and thinking abilities. The FACT-Cog takes into consideration the functional implications of cognitive impairment, the deficits observed by other people, the changes in cognitive function over time, and their impact on the patient's quality of life. Scoring for the FACT-Cog includes calculation of four subscales based on a 5-point Likert scale (from never/not at all (0) to several times a day/very much) : Perceived Cognitive Impairment (20 items; score range 0-80), Impact On Quality Of Life (4 items; score range 0-16), Comments From Others (4 items; score range 0-16), and Perceived Cognitive Abilities (9 items; score range 0-36). The higher the score is, the better the quality of life is.
Measured: At 6 months after inclusion
Frequency of irritability/aggressivity
Irritability and aggressivity will be assessed through patient and proxy interviews and classified dichotomously as present or absent.
Measured: At 6 months after inclusion
Frequency of irritability/aggressivity
Irritability and aggressivity will be assessed through patient and proxy interviews and classified dichotomously as present or absent.
Measured: At 1 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start2 Oct 2026 (estimated)
- Primary completion2 Apr 2030 (estimated)
- Study completion2 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spontaneous Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a phase 3, national, multicentre, randomised, double-blind, 2-arm parallel-group placebo-controlled, superiority clinical trial: * Intervention group: Levetiracetam started within 24 hours of inclusion and continued for 1 month and 15 days. * Control group: Placebo started within 24 hours of inclusion and continued for 1 month and 15 days.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 580 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Derex, DR, Study director, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07336992
- Sponsor's protocol ID
- 69HCL23_0934
- Acronym
- PEACH2
- Status last verified
- Jun 2026
- First submitted
- 17 Sep 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NOT YET DECIDED
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Prophylactic Levetiracetam for Improving Functional Outcome in the Acute Phase of Intracerebral Haemorrhage: a Randomised, Double-blind, Placebo-controlled, Phase 3 Trial
- ClinicalTrials.gov ID
- NCT07336992
- Acronym / sponsor ID
- PEACH2 / 69HCL23_0934
- Conditions
- Spontaneous Intracerebral Hemorrhage
- Keywords
- supratentorial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 580 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 2 Oct 2026 (estimated)
- Primary completion
- 2 Apr 2030 (estimated)
- Study completion
- 2 Oct 2030 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Epileptic seizures are a common complication at the acute phase of intracerebral haemorrhage (ICH). The incidence of seizures occurring within 7 days reaches 40% when subclinical seizures are diagnosed by continuous electroencephalogram (EEG).
Some studies have suggested that early seizures are associated with haematoma expansion (Vespa., Neurology 2003), worse neurological outcomes (Gilmore., Stroke 2016) or increased mortality. By contrast, other studies have shown no association of acute seizures with long-term mortality and outcome. However, the interpretation of these works is subject to bias because almost all studies were based on clinical detection of seizures only, while it has been shown that most early seizures after ICH are clinically unrecognised and can only be diagnosed with EEG monitoring.
The PEACH trial, a double-blind, randomised, placebo-controlled, showed that clinical and/or electrographic seizures occur in more than 40% of patients with ICH and that Levetiracetam (LVT) is safe and effective in preventing these seizures. However, it remains unclear whether preventing acute seizures might lead to improved functional outcomes after ICH. An adequately powered randomised controlled trial is needed to answer whether primary seizure prophylaxis improves functional outcome in this setting. Answering this question would result in an important change in ICH acute care guidelines, which currently do not recommend primary prophylactic antiseizure treatment. As compared to research in acute ischemic stroke management, fewer clinical trials have been conducted in acute ICH and no effective medical treatments are available in this subset of patients.
The main objective of PEACH 2 is to establish if prophylactic antiseizure therapy with LVT improves functional outcome in adults with acute spontaneous ICH. Functional outcome assessed by the modified Rankin score (mRS score) six months after acute ICH will be compared between patients receiving prophylactic antiseizure therapy with levetiracetam and patients receiving placebo.
The secondary objectives are to examine the effect of prophylactic antiseizure therapy with levetiracetam versus placebo on:
- the number of early and late clinical seizures, on the short term and long term evolution of the neurologic deficit as assessed by the NIHSS, on long term functional outcome (12 months) as assessed by the mRS, on quality of life and cognitive impairment, and on haematoma expansion and mass effect on control brain imaging
- the frequency of side effects at 1 and 6 months, pneumonia at 1 month, delirium at 1 month, irritability/aggressivity, anxiety and depression at 1 and 6 months, and all-cause mortality at 1, 6 and 12 months. 580 patients will be recruited over 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a phase 3, national, multicentre, randomised, double-blind, 2-arm parallel-group placebo-controlled, superiority clinical trial: * Intervention group: Levetiracetam started within 24 hours of inclusion and continued for 1 month and 15 days. * Control group: Placebo started within 24 hours of inclusion and continued for 1 month and 15 days.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Drug: Treatment administration (Levetiracetam or placebo), Radiation: Neuroimaging, Diagnostic Test: National Institute of Health Stroke Scale (NIHSS), Behavioral: Modified Rankin Scale (mRS), Behavioral: Euroqol test (EQ-5D-5L), Behavioral: Montreal Cognitive Assessment (MoCA), Behavioral: Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog), Behavioral: Hospital Anxiety and Depression Scale (HADS)290 patients will be recruited over 3 years in the intervention group. In this group, Levetiracetam should be initiated within 24 hours of randomisation. Levetiracetam (500 mg every 12 hours) will be administered intravenously for at least 48 hours and then the route of administration will be changed to oral administration at the same dosage after assessment of swallowing function. The treatment period will be 30 days at full dose, followed by a gradual tapering over 2 weeks (250 mg of levetiracetam every 12 hours for 7 days, followed by 250 mg of levetiracetam every 24 h for 7 days). |
| Control Group | Placebo comparator | Drug: Treatment administration (Levetiracetam or placebo), Radiation: Neuroimaging, Diagnostic Test: National Institute of Health Stroke Scale (NIHSS), Behavioral: Modified Rankin Scale (mRS), Behavioral: Euroqol test (EQ-5D-5L), Behavioral: Montreal Cognitive Assessment (MoCA), Behavioral: Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog), Behavioral: Hospital Anxiety and Depression Scale (HADS)290 patients will be recruited over 3 years in the control group. In this group, the placebo (microcrystalline cellulose) should be initiated within 24 hours of randomisation. The placebo (500 mg every 12 hours) will be administered intravenously for at least 48 hours and then the route of administration will be changed to oral administration at the same dosage after assessment of swallowing function. The treatment period will be 30 days at full dose, followed by a gradual tapering over 2 weeks (250 mg of placebo every 12 hours for 7 days, followed by 250 mg of placebo every 24 h for 7 days). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- Intracerebral haemorrhage known or suspected by study investigator to be secondary to trauma, vascular malformation, haemorrhagic transformation of ischaemic stroke, or tumour
- Current use of antiseizure drugs or history of epilepsy
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment administration (Levetiracetam or placebo)Treatment should be initiated within 24 hours of randomisation. It will be administered intravenously for at least 48 hours and then the route of administration will be changed to oral administration at the same dosage after assessment of swallowing function. The treatment period will be 30 days at full dose, followed by a gradual tapering over 2 weeks. | Drug | Control Group, Intervention Group |
| NeuroimagingNeuroimaging (brain CT or MRI) will be performed 72h post inclusion | Radiation | Control Group, Intervention Group |
| National Institute of Health Stroke Scale (NIHSS)NIHSS, a clinician -reported 11-items stroke-specific severity scale, will be administered by a neurologist during all patients' study visits except at visits 1 month and 12 months. | Diagnostic test | Control Group, Intervention Group |
| Modified Rankin Scale (mRS)This questionnaire will be administered 3 time, at inclusion, 6 months and 12 months to measure post-stroke functional status and disability | Behavioural | Control Group, Intervention Group |
| Euroqol test (EQ-5D-5L)This self-reported questionnaire will be completed by patients at 6 and 12 months, to assess the multidimensional chronic consequences of stroke on their daily lives | Behavioural | Control Group, Intervention Group |
| Montreal Cognitive Assessment (MoCA)This test will be administered by a neurologist at 6 months to assess patients' cognitive impairment | Behavioural | Control Group, Intervention Group |
| Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog)This self-reported questionnaire will be completed by patients at 6 months, to assess patient's cognitive function (memory, attention, concentration, language, and thinking abilities) | Behavioural | Control Group, Intervention Group |
| Hospital Anxiety and Depression Scale (HADS)This questionnaire will be administered at 1 and 6 months to evaluate patients' anxiety and depression | Behavioural | Control Group, Intervention Group |
Primary outcome
modified Rankin Scale (mRS) score to measure the functional status (death or dependency).
Time frame: 6 and 12 months after inclusion
The mRS score will be measured by a certified neurologist, blinded to the patient study group. It categorises disability with reference to pre-stroke activities. mRS is a single-item scale ranging from 0 (no disability) to 5 (severe disability) and 6 (death). Its analysis will be performed by an ordinal logistic regression model with proportional odds and mixed effects. The treatment arm will be introduced in the model as fixed effect and the NIHSS score (≤ 15 vs >15) will be taken into account as a fixed effect. It will also take into account, as random effect, a random intercept by centre.
26 secondary outcomes
Number of clinical seizures
Time frame: within 72 hours after inclusion
Number of clinical seizures
Time frame: at 1 month after inclusion
Number of clinical seizures
Time frame: at 6 months after inclusion
Number of clinical seizures
Time frame: at 12 months after inclusion
Change in National Institute of Health Stroke Scale (NIHSS, 11 items version) score between inclusion and 72 h, and 6 months.
Time frame: At inclusion
Change in National Institute of Health Stroke Scale (NIHSS, 11 items version) score between inclusion and 72 h, and 6 months.
Time frame: At 72 hours
Change in National Institute of Health Stroke Scale (NIHSS, 11 items version) score between inclusion and 72 h, and 6 months.
Time frame: At 6 months after inclusion
Change in modified Rankin Scale (mRS) score between inclusion and 6 months and 12 months
Time frame: At inclusion
Change in modified Rankin Scale (mRS) score between inclusion and 6 months and 12 months
Time frame: At 6 months after inclusion
Change in modified Rankin Scale (mRS) score between inclusion and 6 months and 12 months
Time frame: At 12 months after inclusion
Score at the Euroqol (EQ-5D-5L) to assess quality of life.
Time frame: At 6 months
Score at the Euroqol (EQ-5D-5L) to assess quality of life.
Time frame: At 12 months after inclusion
Score at the Montreal Cognitive Assessment (MoCA) version 8.3 to assess cognitive impairment.
Time frame: 6 months after inclusion
Change in intracerebral haemorrhage volume (ml)
Time frame: 72 hours after inclusion
Frequency of pneumonia
Time frame: 1 month after inclusion
Frequency of side effects related to treatment
Time frame: 1 month after inclusion
Frequency of side effects related to treatment
Time frame: 6 months after inclusion
Frequency of delirium
Time frame: 1 month after inclusion
Score at the Hospital Anxiety and Depression Scale (HADS) to assess anxiety and depression
Time frame: At 6 months after inclusion
Death rate
Time frame: At 1 month after inclusion
Death rate
Time frame: At 6 months after inclusion
Death rate
Time frame: At 12 months after inclusion
Score at the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)
Time frame: At 1 month after inclusion
Score at the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)
Time frame: At 6 months after inclusion
Frequency of irritability/aggressivity
Time frame: At 6 months after inclusion
Frequency of irritability/aggressivity
Time frame: At 1 months after inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: Undecided. NOT YET DECIDED
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Spontaneous Intracerebral Hemorrhage
Not yet recruiting
Haptic-Assisted Virtual Reality Upper-Limb Rehabilitation After Intracerebral Haemorrhage
Intracerebral Hemorrhage, Hemorrhagic Stroke
Not yet recruitingObservational study
Outcome Prediction and Recovery After Spontaneous Intracerebral Haemorrhage
Intracerebral Hemorrhage, Hemorrhagic Stroke
Not yet recruiting
REmifentanil And Dexmedetomidine for EarlY Intensive Blood Pressure Lowering in ICH.
Intracerebral Hemorrhage
Not yet recruitingObservational study
Minimally Invasive Surgery for Spontaneous Deep Intracerebral Hemorrhage
Intracerebral Hemorrhage, Spontaneous Intracerebral Hemorrhage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laurent Derex, DR study director
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Neuroimaging, National Institute of Health Stroke Scale (NIHSS) and Modified Rankin Scale (mRS) in people with Spontaneous Intracerebral Hemorrhage, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurent Derex, DR (04 72 35 78 09, laurent.derex@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Rankin Scale (mRS) score to measure the functional status (death or dependency). (time frame: 6 and 12 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.