Short Duration Levetiracetam to Extended Course for Seizure Prophylaxis After aSAH (DOPAST)

April 29, 2019 updated by: Theresa Human-Murphy, Washington University School of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Barnes-Jewish Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Brief LEV
Administration of three days of levetiracetam twice daily after SAH
Other: Brief LEV
Levetiracetam 1000mg BID x 3 days for prophylaxis
Other: Extended LEV
Administration of levetiracetam twice daily after SAH
Other: Extended LEV
Levetiracetam 1000mg BID for length of hospital stay for prophylaxis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-hospital Seizures
Time Frame: from hospital admission to hospital discharge
from admission to In-hospital seizures after aSAH
from hospital admission to hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Theresa Human-Murphy, Barnes-Jewish Hospital, Washington University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2010

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

May 28, 2010

First Submitted That Met QC Criteria

June 3, 2010

First Posted (Estimate)

June 4, 2010

Study Record Updates

Last Update Posted (Actual)

July 12, 2019

Last Update Submitted That Met QC Criteria

April 29, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-1717

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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