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Seizures Post Intracerebral Hemorrhage

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ClinicalTrials.gov Identifier: NCT01115959
Recruitment Status : Completed
First Posted : May 4, 2010
Last Update Posted : June 12, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Yair Lampl, 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.

Condition or disease Intervention/treatment Phase
Post Cerebral Hemorrhage Drug: valproic acid Drug: placebo bid Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Are Post Intracerebal Hemorrhage Prevented By Anti-Epileptic Treatment?
Study Start Date : February 2003
Actual Primary Completion Date : October 2008
Actual Study Completion Date : December 2008


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



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

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


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

Inclusion Criteria:

  • cerebral hemorrhage spontaneous

Exclusion Criteria:

  • early seizures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr. Yair Lampl, Professor Yair Lampl, Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT01115959     History of Changes
Other Study ID Numbers: 001
First Posted: May 4, 2010    Key Record Dates
Last Update Posted: June 12, 2014
Last Verified: May 2010

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