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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Hillel Yaffe Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT01268904
First received: December 30, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

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 Intervention
Status Epilepticus
Drug: Valproate

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • Safety of intravenous valproate in pediatric status epilepticus [ Time Frame: One week ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy of intravenous valproate in pediatric status epilepticus [ Time Frame: One week ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pediatric status epilepticus Drug: Valproate
Intravenous valproate application to pediatric patients suffering from status epilepticus and acute repetitive seizures

  Eligibility

Ages Eligible for Study:   6 Months to 18 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Iyad Magadly, Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01268904     History of Changes
Other Study ID Numbers: 0098-10-HYMC
Study First Received: December 30, 2010
Last Updated: December 30, 2010
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Status Epilepticus
Brain Diseases
Central Nervous System Diseases
Epilepsy
Nervous System Diseases
Valproic Acid
Anticonvulsants
Antimanic Agents
Central Nervous System Agents
Central Nervous System Depressants
Enzyme Inhibitors
GABA Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 21, 2014