NCT01586208

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2010

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 26, 2012

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

March 12, 2013

Status Verified

March 1, 2013

Enrollment Period

2.3 years

First QC Date

April 24, 2012

Last Update Submit

March 10, 2013

Conditions

Grand Mal Status EpilepticusNon-convulsive Status Epilepticus

Keywords

refractory status epilepticusvalproic acidphenytoinbenzodiazepinesValproic acid initial dosage in status treatment

Outcome Measures

Primary Outcomes (1)

  • status epilepticus resolution

    After 48h treatment administration the status epilepticus has to be solved without any other antiepileptic medications

    after 48h treatment administration

Secondary Outcomes (1)

  • Estimation of pharmacokinetic parameters of valproate (VPA) and phenytoin (PHT)

    During 48h post valproate administration

Study Arms (2)

40mg/kg intial valproate bolus

ACTIVE COMPARATOR

Patient receives a 40mg/kg valproate bolus with a maintenance of 1mg/kg/h, after benzodiazepine + phenytoin administration

Drug: valproic acid (VPA)

20mg/Kg intial bolus valproate

ACTIVE COMPARATOR

Patient receives a 20mg/kg valproate bolus with a maintenance of 1mg/kg/h, after benzodiazepine + phenytoin administration

Drug: valproic acid (VPA)

Interventions

valproic acid (VPA)DRUG

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

Also known as: Valrpoic acid, Phenytoin, Benzodiazepines, Status Epilepticus Refractarius
20mg/Kg intial bolus valproate40mg/kg intial valproate bolus

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

MeSH Terms

Conditions

Status Epilepticus

Interventions

Valproic AcidPhenytoinBenzodiazepines

Condition Hierarchy (Ancestors)

SeizuresNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipidsHydantoinsImidazolidinesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Mercè Falip, MD

    Hospital Universitari de Bellvitge

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 24, 2012

First Posted

April 26, 2012

Study Start

January 1, 2010

Primary Completion

May 1, 2012

Study Completion

October 1, 2012

Last Updated

March 12, 2013

Record last verified: 2013-03

Locations

ES(1)