Trial record 7 of 14 for:    "Epilepsy, Tonic-Clonic"

Refractory Status Epilepticus Treatment Study

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT01586208
First received: April 24, 2012
Last updated: March 10, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Grand Mal Status Epilepticus
Non-convulsive Status Epilepticus
Drug: valproic acid (VPA)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Refractory Status Epilepticus: Plasmatic Levels Monitorization Utility

Resource links provided by NLM:


Further study details as provided by Hospital Universitari de Bellvitge:

Primary Outcome Measures:
  • status epilepticus resolution [ Time Frame: after 48h treatment administration ] [ Designated as safety issue: No ]
    After 48h treatment administration the status epilepticus has to be solved without any other antiepileptic medications


Secondary Outcome Measures:
  • Estimation of pharmacokinetic parameters of valproate (VPA) and phenytoin (PHT) [ Time Frame: During 48h post valproate administration ] [ Designated as safety issue: No ]
    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)


Enrollment: 5
Study Start Date: January 2010
Study Completion Date: October 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01586208

Locations
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
Principal Investigator: Mercè Falip, MD Hospital Universitari de Bellvitge
  More Information

No publications provided

Responsible Party: Mercè Falip, MD, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier: NCT01586208     History of Changes
Other Study ID Numbers: NEU-2009-01
Study First Received: April 24, 2012
Last Updated: March 10, 2013
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital Universitari de Bellvitge:
refractory status epilepticus
valproic acid
phenytoin
benzodiazepines
Valproic acid initial dosage in status treatment

Additional relevant MeSH terms:
Epilepsy, Tonic-Clonic
Status Epilepticus
Epilepsy, Generalized
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Phenytoin
Valproic Acid
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Enzyme Inhibitors
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 28, 2014