Refractory Status Epilepticus Treatment Study

Non-convulsive Status Epilepticus Clinical Trial

Official title:

Refractory Status Epilepticus: Plasmatic Levels Monitorization Utility

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01586208
• Other study ID #: NEU-2009-01
• Status: Completed
• Phase: Phase 3
• First received: April 24, 2012
• Last updated: March 10, 2013
• Start date: January 2010
• Est. completion date: October 2012

Study information

• Verified date: March 2013
• Source: Hospital Universitari de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Description:

Phase III Clinical trial, to identify the most effective dose of valproic acid (20mg/kg bolus, 1mg/kg/h maintenance vs 40mg/kg bolus, 2mg/kg/h maintenance) in combination with phenytoin, in patients with refractory status epilepticus.

Multicenter clinical trial, single-blind, prospective, randomized 1:1 assignment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: October 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. 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.

2. 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):

• After submitting an EER seizures that yield clinically performed an EEG that shows SE electricity.

• Evidence of a non-convulsive SE to perform an EEG of a patient admitted for any cause, either by filing seizures, altered mental status, or any other cause, and to persist after the treatment administered previously discussed.

3. Patients in whom it has obtained the written informed consent by the representative and/or patient, as the case

Exclusion Criteria:

1. Patients with severe cerebral anoxia, when the first EEG evidences a pattern of flare-suppression.

2. Patients who registers PLEDs (periodic epileptic lateralaized Discharges) without clinical seizure activity association to register or without electrical crises.

3. Patients < 18 years of age.

4. Patients in whom there is diagnostic doubt (eg non-convulsive status among and encephalopathy).

5. Pregnant or breastfeeding.

6. Patients with allergy to phenytoin, hydantoin or hypersensitivity to sodium valproate

7. Patients with porphyria

8. Patients with severe liver disease or dysfunction.

9. Patients with heart block or second and third grade sinus bradycardia.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Grand Mal Status Epilepticus
• Non-convulsive Status Epilepticus
• Status Epilepticus

Intervention

Drug:
• valproic acid (VPA)
Best dosage at the initial bolus of VPA in patient with satatus epilepticus refractarius (after benzodiazepine + phenytoin treatment)

Locations

Country	Name	City	State
Spain	Hospital Universitari de Bellvitge	L'Hospitalet de Llobregat	Barcelona

Sponsors (5)

Lead Sponsor	Collaborator
Hospital Universitari de Bellvitge	Germans Trias i Pujol Hospital, Hospital Clinic of Barcelona, Hospital Vall d'Hebron, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	status epilepticus resolution	After 48h treatment administration the status epilepticus has to be solved without any other antiepileptic medications	after 48h treatment administration	No
Secondary	Estimation of pharmacokinetic parameters of valproate (VPA) and phenytoin (PHT)	Estimation of pharmacokinetic parameters of VPA (Cl: clearance, Vd: volume of distribution) and PHT (Vmax: maximum speed of metabolism and Km: plasma concentration at which the rate of metabolism is half the maximum)	During 48h post valproate administration	No