Seizures Post Intracerebral Hemorrhage

June 11, 2014 updated by: Dr. Yair Lampl, Wolfson Medical Center

Are Post Intracerebal Hemorrhage Prevented By Anti-Epileptic Treatment?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • cerebral hemorrhage spontaneous

Exclusion Criteria:

  • early seizures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: valproic acid
Valproic acid given orally 400mg twice daily
Drug: valproic acid
treatment of 1 month dosage of 400 mg BID
Drug: placebo bid
Placebo Comparator: placebo
Placebo twice daily for one month
Drug: placebo bid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of seizures
Time Frame: study drug for 1 month and 1 year follow up
study drug for 1 month and 1 year follow up

Secondary Outcome Measures

Outcome Measure
Time Frame
neurological outcome NIHSS
Time Frame: during 1 month study drug and 1 year post follow up
during 1 month study drug and 1 year post follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wolfson Medical Center

Investigators

  • Principal Investigator: ronit gilad, md, E Wolfson med center
  • Principal Investigator: ronit gilad, md, E wofson med center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

May 2, 2010

First Submitted That Met QC Criteria

May 2, 2010

First Posted (Estimate)

May 4, 2010

Study Record Updates

Last Update Posted (Estimate)

June 12, 2014

Last Update Submitted That Met QC Criteria

June 11, 2014

Last Verified

May 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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