Back to resultsSeizures Post Intracerebral Hemorrhage
Primary Purpose
Post Cerebral Hemorrhage
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
valproic acid
placebo bid
Sponsored by
About this trial
This is an interventional prevention trial for Post Cerebral Hemorrhage
Eligibility Criteria
Inclusion Criteria:
- cerebral hemorrhage spontaneous
Exclusion Criteria:
- early seizures
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
valproic acid
placebo
Arm Description
Valproic acid given orally 400mg twice daily
Placebo twice daily for one month
Outcomes
Primary Outcome Measures
number of seizures
Secondary Outcome Measures
neurological outcome NIHSS
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01115959
Brief Title
Seizures Post Intracerebral Hemorrhage
Official Title
Are Post Intracerebal Hemorrhage Prevented By Anti-Epileptic Treatment?
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wolfson Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Cerebral Hemorrhage
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
valproic acid
Arm Type
Active Comparator
Arm Description
Valproic acid given orally 400mg twice daily
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo twice daily for one month
Intervention Type
Drug
Intervention Name(s)
valproic acid
Intervention Description
treatment of 1 month dosage of 400 mg BID
Intervention Type
Drug
Intervention Name(s)
placebo bid
Primary Outcome Measure Information:
Title
number of seizures
Time Frame
study drug for 1 month and 1 year follow up
Secondary Outcome Measure Information:
Title
neurological outcome NIHSS
Time Frame
during 1 month study drug and 1 year post follow up
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
cerebral hemorrhage spontaneous
Exclusion Criteria:
early seizures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ronit gilad, md
Organizational Affiliation
E Wolfson med center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
ronit gilad, md
Organizational Affiliation
E wofson med center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Seizures Post Intracerebral Hemorrhage
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