Acute intraCerebral Haemorrhage Clinical Trial
— PEACHOfficial title:
Prevention of Epileptic Seizures in Acute intraCerebral Haemorrhage
| NCT number | NCT02631759 |
| Other study ID # | 2014-845 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | |
| Last updated | |
| Start date | October 2016 |
| Est. completion date | June 7, 2021 |
| Verified date | April 2022 |
| Source | Hospices Civils de Lyon |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | June 7, 2021 |
| Est. primary completion date | April 9, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 - 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Department of functional neurology and epileptology | Lyon |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Occurrence of early (day-0 to day-30 ) and late (from day-30 to 12 months) clinical seizures | 12 months | ||
| Other | Functional prognosis at 3 , 6 and 12 months evaluated by the modified Rankin scale | 12 months | ||
| Other | Cerebral oedema and mass effect evaluated by comparing the admission brain CT scan with the control CT scan performed at 72 hours | 72 hours | ||
| Other | Neurological status as assessed by the National Institute of Health Stroke Scale at 72 hours , 1 month and 3 months | 3 months | ||
| Other | Quality of life measured by the Stroke impact Scale at 3, 6 and 12 months | 12 months | ||
| Other | 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) | 3 months | ||
| Primary | Occurrence of at least one clinical or electrical epileptic seizure recorded on continuous 48 hours holter EEG | 48 hours | ||
| Secondary | Occurrence of electroencephalographic signs | 48 hours | ||
| Secondary | Number of EEG seizures | 48 hours | ||
| Secondary | Total duration of epileptic seizures continuously recorded on EEG | 48 hours | ||
| Secondary | occurrence of some paroxysmal EEG patterns | 48 hours |