Seizures Post Intracerebral Hemorrhage

Phase 4

Completed

• Conditions: Post Cerebral Hemorrhage
• Interventions: Drug: valproic acid; Drug: placebo bid

• Registration Number: NCT01115959
• Lead Sponsor: Wolfson Medical Center

Brief Summary

This study examines early antiepileptic treatment with valproic acid for acute cerebral hemorrhage against a placebo group immediately post event to evaluate the outcome of these patients regarding seizures and neurological outcome.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-02
• Primary Completion: 2008-10
• Study Completion: 2008-12
• Status Verified: 2010-05
• Study First Submitted: 2010-05-02
• Study First Submitted QC: 2010-05-02
• Study First Posted: 2010-05-04
• Last Update Submitted: 2014-06-11
• Last Update Posted: 2014-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• cerebral hemorrhage spontaneous

Exclusion Criteria

• early seizures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
valproic acid	placebo bid	Valproic acid given orally 400mg twice daily
placebo	placebo bid	Placebo twice daily for one month
valproic acid	valproic acid	Valproic acid given orally 400mg twice daily

Primary Outcome Measures

Name	Time	Method
number of seizures	study drug for 1 month and 1 year follow up

Secondary Outcome Measures

Name	Time	Method
neurological outcome NIHSS	during 1 month study drug and 1 year post follow up