Short Duration Levetiracetam to Extended Course for Seizure Prophylaxis After aSAH

Not Applicable

Completed

• Conditions: Subarachnoid Hemorrhage
• Interventions: Other: Brief LEV; Other: Extended LEV

• Registration Number: NCT01137110
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-05-01
• Study First Submitted: 2010-05-28
• Study First Submitted QC: 2010-06-03
• Study First Posted: 2010-06-04
• Primary Completion: 2013-01-01
• Study Completion: 2017-01-01
• Results First Submitted: 2018-01-30
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-29
• Last Update Submitted: 2019-04-29
• Results First Posted: 2019-07-12
• Last Update Posted: 2019-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brief LEV	Brief LEV	Administration of three days of levetiracetam twice daily after SAH
Extended LEV	Extended LEV	Administration of levetiracetam twice daily after SAH

Primary Outcome Measures

Name	Time	Method
In-hospital Seizures	from hospital admission to hospital discharge	from admission to In-hospital seizures after aSAH

Trial Locations

Locations (1)

Barnes-jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States