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Seizures Post Intracerebral Hemorrhage

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Yair Lampl, Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT01115959
First received: May 2, 2010
Last updated: June 11, 2014
Last verified: May 2010
  Purpose
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.

Condition Intervention Phase
Post Cerebral Hemorrhage Drug: valproic acid Drug: placebo bid Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Are Post Intracerebal Hemorrhage Prevented By Anti-Epileptic Treatment?

Resource links provided by NLM:


Further study details as provided by Dr. Yair Lampl, Wolfson Medical Center:

Primary Outcome Measures:
  • number of seizures [ Time Frame: study drug for 1 month and 1 year follow up ]

Secondary Outcome Measures:
  • neurological outcome NIHSS [ Time Frame: during 1 month study drug and 1 year post follow up ]

Enrollment: 72
Study Start Date: February 2003
Study Completion Date: December 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • cerebral hemorrhage spontaneous

Exclusion Criteria:

  • early seizures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01115959

Sponsors and Collaborators
Wolfson Medical Center
Investigators
Principal Investigator: ronit gilad, md E Wolfson med center
Principal Investigator: ronit gilad, md E wofson med center
  More Information

Responsible Party: Dr. Yair Lampl, Professor Yair Lampl, Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT01115959     History of Changes
Other Study ID Numbers: 001
Study First Received: May 2, 2010
Last Updated: June 11, 2014

Additional relevant MeSH terms:
Hemorrhage
Cerebral Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Valproic Acid
Anticonvulsants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on June 23, 2017