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NCT01268904 Clinical Trial

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

Status Epilepticus Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01268904
Other study ID # 0098-10-HYMC
Secondary ID
Status Not yet recruiting
Phase N/A
First received December 30, 2010
Last updated December 30, 2010
Start date January 2011
Est. completion date August 2013

Study information
Verified date December 2010
Source Hillel Yaffe Medical Center
Contact Iyad Magadly, MD
Phone 972-4-6304331
Email magadly@gmail.com
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date August 2013
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Both
Age group 6 Months to 18 Years
Eligibility Inclusion Criteria:

- Child with clinical presentation of status epilepticus

Exclusion Criteria:

- All others

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Valproate
Intravenous valproate application to pediatric patients suffering from status epilepticus and acute repetitive seizures

Locations
Country Name City State
Israel Hillel Yaffe Medical Center Hadera

Sponsors (1)
Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety of intravenous valproate in pediatric status epilepticus One week Yes
Secondary Efficacy of intravenous valproate in pediatric status epilepticus One week No
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