Acute intraCerebral HaemorrhagePhase 3PEACHNCT02631759
Prevention of Epileptic Seizures in Acute intraCerebral Haemorrhage
A Phase 3 study testing Lévétiracetam in people with Acute intraCerebral Haemorrhage, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Haemorrhagic strokes represent about 10-15 % of all strokes and 30,000 cases per year in France. The 30-day death rate ranges from 30 to 55% (50% of deaths occurring within 48 hours). Currently, no urgent medical or surgical treatment has been shown to improve functional or vital prognosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute intraCerebral Haemorrhage
- What is being tested?
- Lévétiracetam
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2016to 7 Jun 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 greater than 18 years with no upper age limit
- Competent adult patient.
- Patient affiliated to the French National Health Insurance.
- Patient with supratentorial spontaneous intracerebral hemorrhage diagnosed by CT or MRI
- Early neurological symptoms less than 24 hours
- NIHSS score on admission between 5 and 25
- Informed consent given by the patient or his legal representative
Who cannot join
- Inaugural Seizures ( at the onset of symptoms associated with intracerebral hemorrhage )
- Seizures occurring between the inclusion of the patient and the start of the EEG
- Other Intracerebral hemorrhage infratentorial , post-traumatic , related to a vascular malformation or an underlying tumor and secondarily hemorrhagic cerebral infarction
- Current antiepileptic treatment when intracerebral hemorrhage , or a history of epilepsy
- Modified Rankin Scale before intracerebral hemorrhage > 1 (indicating a preexisting disability)
- Serious illness which can affect the prognosis within 3 months
Show all 12Show fewer
- Severe renal impairment ( creatinine clearance <30 ml / min)
- Pregnancy, lactation
- Known hypersensitivity to levetiracetam or other pyrrolidone derivatives , or any of the excipients.
- Untreated severe depression , psychotic disorders
- Lactose Intolerance
- Patient under measuring socio- legal protection
Trial locations and contacts
1 site in 1 country.
About this study
Haemorrhagic strokes represent about 10-15 % of all strokes and 30,000 cases per year in France. The 30-day death rate ranges from 30 to 55% (50% of deaths occurring within 48 hours). Currently, no urgent medical or surgical treatment has been shown to improve functional or vital prognosis. Clinical epileptic seizures frequency in acute intracerebral haemorrhage has been estimated between 4% and 16% but the occurrence of subclinical epileptic seizures (detected on the electroencephalogram (EEG) only) could be much more frequent (28 % to 40 %).
Some studies have suggested that early repeated epileptic seizures may be associated with a worse neurological prognosis. Repeated epileptic seizures occurring in the acute phase may increase brain oedema, worsen, hypoxia and may lead to cellular death in the injured brain tissue. Thus, prevention of early epileptic seizures may improve neurological outcome. However, the efficacy of a systematic prophylactic antiepileptic treatment on clinical and subclinical epileptic seizures has not been evaluated in the setting of intracerebral haemorrhage. The current European guidelines recommend the use of antiepileptic drugs only when epileptic seizures occur.
Read more
Primary objective: PEACH is a randomized controlled trial aiming at evaluating the impact of systematic prophylactic antiepileptic treatment with levetiracetam versus placebo in acute supratentorial spontaneous intracerebral haemorrhage. The primary endpoint is the occurrence of at least one clinical or electrical epileptic seizure recorded on continuous 48h holter EEG.
Secondary Objectives:This study also aims to assess:
Ä The efficacy of prophylactic treatment with levetiracetam on the number of EEG seizures, on the total duration of epileptic seizures continuously recorded on EEG, on the occurrence of some paroxysmal EEG patterns, on the number of clinical seizures occurred during 72 hours of diagnosis, on the occurrence of early (day-0 to day-30 ) and late (from day-30 to 12 months) clinical seizures, on the functional prognosis at 3 , 6 and 12 months evaluated by the modified Rankin scale , on the cerebral oedema and mass effect evaluated by comparing the admission brain CT scan with the control CT scan performed at 72 hours, on the neurological status as assessed by the National Institute of Health Stroke Scale at 72 hours , 1 month and 3 months and on the quality of life measured by the Stroke impact Scale at 3, 6 and 12 months.
Ä The frequency of side effects related to treatment with levetiracetam (anxiety and depression assessed by the Hospital Anxiety and Depression Scale at 1 and 3 months) Sample Size: 104 patients will be recruited over 2 years.
- Conditions
- Acute intraCerebral Haemorrhage
- Being tested
- Lévétiracetam, Placebo
- Keywords
- Acute intraCerebral Haemorrhage, Epileptic seizures, Lévétiracetam
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LévétiracetamDrug
Levetiracetam will be administered at 500mg / 12h through IV started within 24 hours after enrollment in the study for at least 48 hours and for up to 5 days, then a per os administration will be made out as soon as oral will be possible, at a dose of 500mg / 12h (1g / day in two divided doses ) .
The total duration of treatment will be 1 month and 15 days taking into account the processing taking decay phase.
The decay phase takes place in two phases:
- A phase of 7 days of levetiracetam 250 mg every 12 hours ( morning and evening)
- Then a phase of 7 days of levetiracetam 250 mg every 24 hours (evening).
PlaceboDrug
Placebo (NaCl 0,9%) will be administered at 500mg / 12h through IV started within 24 hours after enrollment in the study for at least 48 hours and for up to 5 days, then a per os administration will be made out as soon as oral will be possible, at a dose of 500mg / 12h (1g / day in two divided doses ) .
The total duration of treatment will be 1 month and 15 days taking into account the processing taking decay phase.
The decay phase takes place in two phases:
- A phase of 7 days of placebo 250 mg every 12 hours ( morning and evening)
- Then a phase of 7 days of placebo 250 mg every 24 hours (evening).
| Study group | Role | What they receive |
|---|---|---|
| Lévétiracetam | Experimental | 52 patients will be recruited over 2 years in the experimental group Receives: Drug: Lévétiracetam |
| Placebo | Placebo comparator | 52 patients will be recruited over 2 years in the control group Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of at least one clinical or electrical epileptic seizure recorded on continuous 48 hours holter EEG
Measured: 48 hours
Secondary outcomes (4)
Occurrence of electroencephalographic signs
Measured: 48 hours
Number of EEG seizures
Measured: 48 hours
Total duration of epileptic seizures continuously recorded on EEG
Measured: 48 hours
occurrence of some paroxysmal EEG patterns
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startOct 2016
- Primary completion9 Apr 2021
- Study completion7 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute intraCerebral HaemorrhageStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laure Peter-Derex, MD, Study director, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02631759
- Sponsor's protocol ID
- 2014-845
- Acronym
- PEACH
- Status last verified
- Apr 2022
- First submitted
- 7 Dec 2015
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Peter-Derex L, Philippeau F, Garnier P, Andre-Obadia N, Boulogne S, Catenoix H, Convers P, Mazzola L, Gouttard M, Esteban M, Fontaine J, Mechtouff L, Ong E, Cho TH, Nighoghossian N, Perreton N, Termoz A, Haesebaert J, Schott AM, Rabilloud M, Pivot C, Dhelens C, Filip A, Berthezene Y, Rheims S, Boutitie F, Derex L. Safety and efficacy of prophylactic levetiracetam for prevention of epileptic seizures in the acute phase of intracerebral haemorrhage (PEACH): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2022 Sep;21(9):781-791. doi: 10.1016/S1474-4422(22)00235-6.
PubMed 35963261
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Epileptic Seizures in Acute intraCerebral Haemorrhage
- ClinicalTrials.gov ID
- NCT02631759
- Acronym / sponsor ID
- PEACH / 2014-845
- Conditions
- Acute intraCerebral Haemorrhage
- Keywords
- Acute intraCerebral Haemorrhage, Epileptic seizures, Lévétiracetam
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- 9 Apr 2021 (actual)
- Study completion
- 7 Jun 2021 (actual)
- First posted
- 16 Dec 2015 (estimated)
- 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.
Haemorrhagic strokes represent about 10-15 % of all strokes and 30,000 cases per year in France. The 30-day death rate ranges from 30 to 55% (50% of deaths occurring within 48 hours). Currently, no urgent medical or surgical treatment has been shown to improve functional or vital prognosis. Clinical epileptic seizures frequency in acute intracerebral haemorrhage has been estimated between 4% and 16% but the occurrence of subclinical epileptic seizures (detected on the electroencephalogram (EEG) only) could be much more frequent (28 % to 40 %).
Some studies have suggested that early repeated epileptic seizures may be associated with a worse neurological prognosis. Repeated epileptic seizures occurring in the acute phase may increase brain oedema, worsen, hypoxia and may lead to cellular death in the injured brain tissue. Thus, prevention of early epileptic seizures may improve neurological outcome. However, the efficacy of a systematic prophylactic antiepileptic treatment on clinical and subclinical epileptic seizures has not been evaluated in the setting of intracerebral haemorrhage. The current European guidelines recommend the use of antiepileptic drugs only when epileptic seizures occur.
Primary objective: PEACH is a randomized controlled trial aiming at evaluating the impact of systematic prophylactic antiepileptic treatment with levetiracetam versus placebo in acute supratentorial spontaneous intracerebral haemorrhage. The primary endpoint is the occurrence of at least one clinical or electrical epileptic seizure recorded on continuous 48h holter EEG.
Secondary Objectives:This study also aims to assess:
Ä The efficacy of prophylactic treatment with levetiracetam on the number of EEG seizures, on the total duration of epileptic seizures continuously recorded on EEG, on the occurrence of some paroxysmal EEG patterns, on the number of clinical seizures occurred during 72 hours of diagnosis, on the occurrence of early (day-0 to day-30 ) and late (from day-30 to 12 months) clinical seizures, on the functional prognosis at 3 , 6 and 12 months evaluated by the modified Rankin scale , on the cerebral oedema and mass effect evaluated by comparing the admission brain CT scan with the control CT scan performed at 72 hours, on the neurological status as assessed by the National Institute of Health Stroke Scale at 72 hours , 1 month and 3 months and on the quality of life measured by the Stroke impact Scale at 3, 6 and 12 months.
Ä The frequency of side effects related to treatment with levetiracetam (anxiety and depression assessed by the Hospital Anxiety and Depression Scale at 1 and 3 months) Sample Size: 104 patients will be recruited over 2 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
| Arm | Type | Receives |
|---|---|---|
| Lévétiracetam | Experimental | Drug: Lévétiracetam52 patients will be recruited over 2 years in the experimental group |
| Placebo | Placebo comparator | Drug: Placebo52 patients will be recruited over 2 years in the control group |
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 greater than 18 years with no upper age limit
- Competent adult patient.
- Patient affiliated to the French National Health Insurance.
- Patient with supratentorial spontaneous intracerebral hemorrhage diagnosed by CT or MRI
- Early neurological symptoms less than 24 hours
Key exclusion criteria (12 listed)
- Inaugural Seizures ( at the onset of symptoms associated with intracerebral hemorrhage )
- Seizures occurring between the inclusion of the patient and the start of the EEG
- Other Intracerebral hemorrhage infratentorial , post-traumatic , related to a vascular malformation or an underlying tumor and secondarily hemorrhagic cerebral infarction
- Current antiepileptic treatment when intracerebral hemorrhage , or a history of epilepsy
- Modified Rankin Scale before intracerebral hemorrhage > 1 (indicating a preexisting disability)
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 |
|---|---|---|
| LévétiracetamLevetiracetam will be administered at 500mg / 12h through IV started within 24 hours after enrollment in the study for at least 48 hours and for up to 5 days, then a per os administration will be made out as soon as oral will be possible, at a dose of 500mg / 12h (1g / day in two divided doses ) . The total duration of treatment will be 1 month and 15 days taking into account the processing taking decay phase. The decay phase takes place in two phases: * A phase of 7 days of levetiracetam 250 mg every 12 hours ( morning and evening) * Then a phase of 7 days of levetiracetam 250 mg every 24 hours (evening). | Drug | Lévétiracetam |
| PlaceboPlacebo (NaCl 0,9%) will be administered at 500mg / 12h through IV started within 24 hours after enrollment in the study for at least 48 hours and for up to 5 days, then a per os administration will be made out as soon as oral will be possible, at a dose of 500mg / 12h (1g / day in two divided doses ) . The total duration of treatment will be 1 month and 15 days taking into account the processing taking decay phase. The decay phase takes place in two phases: * A phase of 7 days of placebo 250 mg every 12 hours ( morning and evening) * Then a phase of 7 days of placebo 250 mg every 24 hours (evening). | Drug | Placebo |
Primary outcome
Occurrence of at least one clinical or electrical epileptic seizure recorded on continuous 48 hours holter EEG
Time frame: 48 hours
4 secondary outcomes
Occurrence of electroencephalographic signs
Time frame: 48 hours
Number of EEG seizures
Time frame: 48 hours
Total duration of epileptic seizures continuously recorded on EEG
Time frame: 48 hours
occurrence of some paroxysmal EEG patterns
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Results publication: PubMed 35963261Peter-Derex L, Philippeau F, Garnier P, Andre-Obadia N, Boulogne S, Catenoix H, Convers P, Mazzola L, Gouttard M, Esteban M, Fontaine J, Mechtouff L, Ong E, Cho TH, Nighoghossian N, Perreton N, Termoz A, Haesebaert J, Schott AM, Rabilloud M, Pivot C, Dhelens C, Filip A, Berthezene Y, Rheims S, Boutitie F, Derex L. Safety and efficacy of prophylactic levetiracetam for prevention of epileptic seizures in the acute phase of intracerebral haemorrhage (PEACH): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2022 Sep;21(9):781-791. doi: 10.1016/S1474-4422(22)00235-6.
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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. This study is not recruiting at the moment.
Laure Peter-Derex, MD 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 Lévétiracetam in people with Acute intraCerebral Haemorrhage, 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 12 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: finished, as of the sponsor's last update on 26 Sep 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of at least one clinical or electrical epileptic seizure recorded on continuous 48 hours holter EEG (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02631759, which also lists 1 linked publication.
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 26 Sep 2025.