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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Hospices Civils De Lyon

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Decision date (initial)

2026-04-02

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

DGOS

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Therapy

to establish if primary prophylactic antiseizure drug improves functional outcome at 6 months in patients with ICH.

Secondary objectives 2

1. to examine the effect of prophylactic antiseizure therapy with Levetiracetam on the number of early and late clinical seizures, the short term and long-term evolution of the neurologic deficit, the quality of life and the cognitive impairments, the long-term functional outcome at 12 months, and on haematoma expansion and mass effect on control brain imaging
2. to examine the effect of prophylactic antiseizure therapy with Levetiracetam on the frequency of side effects, pneumonia and delirium, on anxiety, depression and mortality.

Conditions and MedDRA coding

intracerebral haemorrhage

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. - Age ≥ 18 years
2. Spontaneous (non-traumatic) supratentorial intracerebral haemorrhage diagnosed by brain CT or MRI
3. Onset of neurologic symptoms within 24 hours
4. NIHSS score on admission ≤ 25
5. Informed consent given by the patient or his/her impartial witness
6. Patients benefiting from a social insurance system or a similar system

Exclusion criteria 13

1. Intracerebral haemorrhage known or suspected by study investigator to be secondary to trauma, vascular malformation, haemorrhagic transformation of ischaemic stroke, or cerebral tumour
2. Current use of antiseizure drugs or history of epilepsy
3. Severe renal insufficiency (creatinine clearance < 30 ml/min)
4. Pregnancy or breastfeeding
5. Previous history of severe depression, or psychotic disorder or suicidal attempt
6. - Known terminal illness
7. Known allergy or hypersensitivity to Levetiracetam or other pyrrolidone derivatives, or any of the excipients.
8. Known allergy or hypersensitivity to microcrystalline cellulose or lactose
9. Being under legal protection
10. Patients with inaugural seizures at the onset of symptoms associated with intracerebral hemorrhage
11. Patients with QTc prolongation
12. 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
13. Patients taking probenecid, methotrexate or macrogol

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Secondary endpoints 12

1. number of clinical seizures within 72 h and at 1, 6 and 12 months
2. change in National Institute of Health Stroke Scale (NIHSS, 11 items version) score between inclusion and 72 h and 6 months.
3. cognitive impairment assessed by the Montreal Cognitive Assessment (MoCA) version 8.3 at 6 months.
4. Cognitive complaint assessed by the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) version 3 at 6 months.
5. Quality of life assessed by the EuroQol - 5D-5L (EQ-5D-5L) at 6 and 12 months.
6. modified Rankin Scale (mRS) score at 12 months
7. Change in intracerebral haemorrhage volume (cc) and mass effect (mm) defined as midline shift on control brain imaging at 72 hours
8. Frequency of side effects related to treatment at 1 and 6 months
9. Frequency of pneumonia at 1 month
10. Frequency of delirium at 1 month
11. - anxiety and depression evaluated with the Hospital Anxiety and Depression Scale (HADS) at one and 6 months.
12. all-cause mortality at 1, 6 and 12 months

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hospices Civils De Lyon

Sponsor organisation

Hospices Civils De Lyon

Address

3 Quai Des Celestins, Bp 2251 Bp 2251

City

Lyon Cedex 02

Postcode

69229

Country

France

Scientific contact point

Organisation

Hospices Civils De Lyon

Contact name

Dr Laurent DEREX

Public contact point

Organisation

Hospices Civils De Lyon

Contact name

Dr Laurent DEREX

Locations

1 EU/EEA country · 15 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 18 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications