Brief 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). 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, 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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

580

participants targeted

Target at P75+ for phase_3

Timeline

45mo left

Started Jan 2026

Typical duration for phase_3

Geographic Reach

1 country

1 active site

Status

not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4 years study duration

Study Progress9%

Jan 2026Jan 2030

First Submitted

Initial submission to the registry

September 17, 2025

Completed

4 months until next milestone

Study Start

First participant enrolled

January 2, 2026

Completed

11 days until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed

3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2029

Expected

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2030

Last Updated

January 13, 2026

Status Verified

September 1, 2025

Enrollment Period

3.5 years

First QC Date

September 17, 2025

Last Update Submit

January 2, 2026

Conditions

Spontaneous Intracerebral Hemorrhage

Keywords

supratentorial

Outcome Measures

Primary Outcomes (1)

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.
6 months after inclusion

Secondary Outcomes (23)

Number of clinical seizures
within 72 hours after inclusion
Number of clinical seizures
at 1 month after inclusion
Number of clinical seizures
at 6 months after inclusion
Number of clinical seizures
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.
At inclusion
+18 more secondary outcomes

Study Arms (2)

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).

Drug: Treatment administration (Levetiracetam or placebo)Radiation: NeuroimagingDiagnostic 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).

Interventions

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.