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Safety and Efficacy of Intravenous Valproate in Pediatric Status Epilepticus and Acute Repetitive Seizures

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ClinicalTrials.gov Identifier: NCT01268904
Recruitment Status : Unknown
Verified December 2010 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : December 31, 2010
Last Update Posted : December 31, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
To evaluate the safety and efficacy of intravenous valproate in pediatric status epilepticus and acute repetitive seizures as part of seizure treatment protocol in pediatric ER

Condition or disease Intervention/treatment
Status Epilepticus Drug: Valproate

Study Design

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : January 2011
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Pediatric status epilepticus Drug: Valproate
Intravenous valproate application to pediatric patients suffering from status epilepticus and acute repetitive seizures


Outcome Measures

Primary Outcome Measures :
  1. Safety of intravenous valproate in pediatric status epilepticus [ Time Frame: One week ]

Secondary Outcome Measures :
  1. Efficacy of intravenous valproate in pediatric status epilepticus [ Time Frame: One week ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Pediatric inpatients and emergency patients
Criteria

Inclusion Criteria:

  • Child with clinical presentation of status epilepticus

Exclusion Criteria:

  • All others
Contacts and Locations

Information from the National Library of Medicine

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): NCT01268904


Contacts
Contact: Iyad Magadly, MD 972-4-6304331 magadly@gmail.com

Locations
Israel
Hillel Yaffe Medical Center Not yet recruiting
Hadera, Israel, 38100
Principal Investigator: Iyad Magadly, MD         
Sponsors and Collaborators
Hillel Yaffe Medical Center
More Information

Responsible Party: Iyad Magadly, Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01268904     History of Changes
Other Study ID Numbers: 0098-10-HYMC
First Posted: December 31, 2010    Key Record Dates
Last Update Posted: December 31, 2010
Last Verified: December 2010

Additional relevant MeSH terms:
Status Epilepticus
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
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