Short Duration Levetiracetam to Extended Course for Seizure Prophylaxis After aSAH

NCT ID: NCT01137110

Last Updated: 2019-07-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-01

Study Completion Date

2017-01-01

Brief Summary

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Our primary objective is to compare two treatment options for prevention of seizures following a subarachnoid hemorrhage and determine if a short-course regimen of levetiracetam is as efficacious in the prevention of in-hospital seizures when compared to an extended course.

Detailed Description

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This is a prospective, single-center, randomized, controlled trial. Patients admitted with spontaneous SAH (and meet enrollment criteria) will be randomized to either levetiracetam 1000 mg twice daily for 3 days or levetiracetam 1000mg twice daily until hospital discharge.

Conditions

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Subarachnoid Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Brief LEV

Administration of three days of levetiracetam twice daily after SAH

Group Type OTHER

Brief LEV

Intervention Type OTHER

Levetiracetam 1000mg BID x 3 days for prophylaxis

Extended LEV

Administration of levetiracetam twice daily after SAH

Group Type OTHER

Extended LEV

Intervention Type OTHER

Levetiracetam 1000mg BID for length of hospital stay for prophylaxis

Interventions

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Brief LEV

Levetiracetam 1000mg BID x 3 days for prophylaxis

Intervention Type OTHER

Extended LEV

Levetiracetam 1000mg BID for length of hospital stay for prophylaxis

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age \>18 years of age
2. Diagnosis of spontaneous SAH

Exclusion Criteria

1. SAH secondary to trauma or arteriovenous malformation
2. Early death (defined as death within 3 days of presentation)
3. Known allergy to levetiracetam
4. Know seizure history on chronic AEDs
5. Pregnancy
6. Current incarceration
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Theresa Human-Murphy

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Theresa Human-Murphy

Role: PRINCIPAL_INVESTIGATOR

Barnes-Jewish Hospital, Washington University

Locations

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Barnes-jewish Hospital

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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09-1717

Identifier Type: -

Identifier Source: org_study_id

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