Prevention of Epileptic Seizures in Acute intraCerebral Haemorrhage

PHASE3CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

October 31, 2016

Primary Completion Date

April 9, 2021

Study Completion Date

June 7, 2021

Conditions
Acute intraCerebral Haemorrhage
Interventions
DRUG

Lévétiracetam

"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)."

DRUG

Placebo

"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)."

Trial Locations (1)

Unknown

Department of functional neurology and epileptology, Lyon

All Listed Sponsors
lead

Hospices Civils de Lyon

OTHER

NCT02631759 - Prevention of Epileptic Seizures in Acute intraCerebral Haemorrhage | Biotech Hunter | Biotech Hunter