CompletedPhase 3

Refractory Status Epilepticus Treatment Study

Spain5 participantsStarted 2010-01

Plain-language summary

Identify the most effective dose of valproic acid when used in combination with phenytoin for treatment of patients with refractory status epilepticus, which allow a better clinical course and prognosis of the disease.

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients ≥ 18 years of age who meet the diagnosis of EER seizure, and previously they have been treated according to the clinical protocol at our center status (Diazepam 10mg Clonazepam 1mg and Phenytoin or iv at a dose of 20mg/kg in case persistence of the clinic):
✓Present seizures for at least 30 minutes without regaining awareness among them.
✓. Patients ≥ 18 years of age who meet the diagnosis of nonconvulsive EER, and previously they have been treated according to the clinical protocol at our center status (Diazepam 10mg Clonazepam 1mg and Phenytoin or iv at a dose of 20mg/kg in case persistence of the clinic):
✓. Patients in whom it has obtained the written informed consent by the representative and/or patient, as the case

Exclusion criteria

✕. Patients with severe cerebral anoxia, when the first EEG evidences a pattern of flare-suppression.
✕. Patients who registers PLEDs (periodic epileptic lateralaized Discharges) without clinical seizure activity association to register or without electrical crises.
✕. Patients \< 18 years of age.
✕. Patients in whom there is diagnostic doubt (eg non-convulsive status among and encephalopathy).
✕. Pregnant or breastfeeding.
✕. Patients with allergy to phenytoin, hydantoin or hypersensitivity to sodium valproate
✕. Patients with porphyria
✕. Patients with severe liver disease or dysfunction.

What they're measuring

status epilepticus resolution

Timeframe: after 48h treatment administration

Trial details

NCT IDNCT01586208

SponsorHospital Universitari de Bellvitge

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-05

View on ClinicalTrials.gov More Grand Mal Status Epilepticus trials