Seizures Post Intracerebral Hemorrhage

NCT ID: NCT01115959

Last Updated: 2014-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Post Cerebral Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Study Groups

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valproic acid

Valproic acid given orally 400mg twice daily

Group Type ACTIVE_COMPARATOR

valproic acid

Intervention Type DRUG

treatment of 1 month dosage of 400 mg BID

placebo bid

Intervention Type DRUG

placebo

Placebo twice daily for one month

Group Type PLACEBO_COMPARATOR

placebo bid

Intervention Type DRUG

Interventions

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valproic acid

treatment of 1 month dosage of 400 mg BID

Intervention Type DRUG

placebo bid

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* cerebral hemorrhage spontaneous

Exclusion Criteria

* early seizures
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wolfson Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr. Yair Lampl

Professor Yair Lampl

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ronit gilad, md

Role: PRINCIPAL_INVESTIGATOR

E Wolfson med center

ronit gilad, md

Role: PRINCIPAL_INVESTIGATOR

E wofson med center

Other Identifiers

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001

Identifier Type: -

Identifier Source: org_study_id

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