Short Duration Levetiracetam to Extended Course for Seizure Prophylaxis After aSAH

Subarachnoid Hemorrhage Clinical Trial

— DOPAST  

Official title:

Comparison of Short Duration Levetiracetam to Extended Course Levetiracetam for Seizure Prophylaxis Following Subarachnoid Hemorrhage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01137110
• Other study ID #: 09-1717
• Status: Completed
• Phase: N/A
• Start date: May 1, 2010
• Est. completion date: January 1, 2017

Study information

• Verified date: April 2019
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: January 1, 2017
• Est. primary completion date: January 1, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Seizures
• Subarachnoid Hemorrhage

Intervention

Other:
• Brief LEV
Levetiracetam 1000mg BID x 3 days for prophylaxis
• Extended LEV
Levetiracetam 1000mg BID for length of hospital stay for prophylaxis

Locations

Country	Name	City	State
United States	Barnes-jewish Hospital	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-hospital Seizures	from admission to In-hospital seizures after aSAH	from hospital admission to hospital discharge