NCT01268904

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 31, 2010

Completed
1 day until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

December 31, 2010

Status Verified

December 1, 2010

Enrollment Period

2.5 years

First QC Date

December 30, 2010

Last Update Submit

December 30, 2010

Conditions

Outcome Measures

Primary Outcomes (1)

  • Safety of intravenous valproate in pediatric status epilepticus

    One week

Secondary Outcomes (1)

  • Efficacy of intravenous valproate in pediatric status epilepticus

    One week

Study Arms (1)

Pediatric status epilepticus

Drug: Valproate

Interventions

Intravenous valproate application to pediatric patients suffering from status epilepticus and acute repetitive seizures

Pediatric status epilepticus

Eligibility Criteria

Age6 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Pediatric inpatients and emergency patients

You may qualify if:

  • Child with clinical presentation of status epilepticus

You may not qualify if:

  • All others

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Status Epilepticus

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

SeizuresNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Central Study Contacts

Iyad Magadly, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 30, 2010

First Posted

December 31, 2010

Study Start

January 1, 2011

Primary Completion

July 1, 2013

Study Completion

August 1, 2013

Last Updated

December 31, 2010

Record last verified: 2010-12

Locations