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Refractory Status Epilepticus Treatment Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01586208
Recruitment Status : Completed
First Posted : April 26, 2012
Last Update Posted : March 12, 2013
Sponsor:
Collaborators:
Hospital Vall d'Hebron
Germans Trias i Pujol Hospital
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Hospital Clinic of Barcelona
Information provided by (Responsible Party):
Mercè Falip, Hospital Universitari de Bellvitge

Study Description
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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.

Condition or disease Intervention/treatment Phase
Grand Mal Status Epilepticus Non-convulsive Status Epilepticus Drug: valproic acid (VPA) Phase 3

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Refractory Status Epilepticus: Plasmatic Levels Monitorization Utility
Study Start Date : January 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 40mg/kg intial valproate bolus
Patient receives a 40mg/kg valproate bolus with a maintenance of 1mg/kg/h, after benzodiazepine + phenytoin administration
 Drug: valproic acid (VPA)
Best dosage at the initial bolus of VPA in patient with satatus epilepticus refractarius (after benzodiazepine + phenytoin treatment)
Other Names:
  • Valrpoic acid
  • Phenytoin
  • Benzodiazepines
  • Status Epilepticus Refractarius
Active Comparator: 20mg/Kg intial bolus valproate
Patient receives a 20mg/kg valproate bolus with a maintenance of 1mg/kg/h, after benzodiazepine + phenytoin administration
 Drug: valproic acid (VPA)
Best dosage at the initial bolus of VPA in patient with satatus epilepticus refractarius (after benzodiazepine + phenytoin treatment)
Other Names:
  • Valrpoic acid
  • Phenytoin
  • Benzodiazepines
  • Status Epilepticus Refractarius


Outcome Measures
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Primary Outcome Measures :
  1. status epilepticus resolution [ Time Frame: after 48h treatment administration ]
    After 48h treatment administration the status epilepticus has to be solved without any other antiepileptic medications


Secondary Outcome Measures :
  1. Estimation of pharmacokinetic parameters of valproate (VPA) and phenytoin (PHT) [ Time Frame: During 48h post valproate administration ]
    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)


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01586208


Locations
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Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Sponsors and Collaborators
Hospital Universitari de Bellvitge
Hospital Vall d'Hebron
Germans Trias i Pujol Hospital
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Hospital Clinic of Barcelona
Investigators
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Principal Investigator: Mercè Falip, MD Hospital Universitari de Bellvitge
More Information
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Responsible Party: Mercè Falip, MD, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier: NCT01586208    
Other Study ID Numbers: NEU-2009-01
First Posted: April 26, 2012    Key Record Dates
Last Update Posted: March 12, 2013
Last Verified: March 2013
Keywords provided by Mercè Falip, Hospital Universitari de Bellvitge:
refractory status epilepticus
valproic acid
phenytoin
benzodiazepines
Valproic acid initial dosage in status treatment
Additional relevant MeSH terms:
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Status Epilepticus
Seizures
Neurologic Manifestations
Nervous System Diseases
Phenytoin
Valproic Acid
Anticonvulsants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
 Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers