Seizures Post Intracerebral Hemorrhage

Post Cerebral Hemorrhage Clinical Trial

Official title:

Are Post Intracerebal Hemorrhage Prevented By Anti-Epileptic Treatment?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01115959
• Other study ID #: 001
• Status: Completed
• Phase: Phase 4
• First received: May 2, 2010
• Last updated: June 11, 2014
• Start date: February 2003
• Est. completion date: December 2008

Study information

• Verified date: May 2010
• Source: Wolfson Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• cerebral hemorrhage spontaneous

Exclusion Criteria:

• early seizures

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Post Cerebral Hemorrhage

Intervention

Drug:
• valproic acid
treatment of 1 month dosage of 400 mg BID
• placebo bid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wolfson Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of seizures		study drug for 1 month and 1 year follow up	No
Secondary	neurological outcome NIHSS		during 1 month study drug and 1 year post follow up	No