search
Back to results

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

Primary Purpose

Subarachnoid Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief LEV
Extended LEV
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Subarachnoid Hemorrhage focused on measuring Subarachnoid Hemorrhage, Seizure Prophylaxis, Levetiracetam

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Barnes-jewish Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Brief LEV

Extended LEV

Arm Description

Administration of three days of levetiracetam twice daily after SAH

Administration of levetiracetam twice daily after SAH

Outcomes

Primary Outcome Measures

In-hospital Seizures
from admission to In-hospital seizures after aSAH

Secondary Outcome Measures

Full Information

First Posted
May 28, 2010
Last Updated
April 29, 2019
Sponsor
Washington University School of Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT01137110
Brief Title
Short Duration Levetiracetam to Extended Course for Seizure Prophylaxis After aSAH
Acronym
DOPAST
Official Title
Comparison of Short Duration Levetiracetam to Extended Course Levetiracetam for Seizure Prophylaxis Following Subarachnoid Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2010 (Actual)
Primary Completion Date
January 1, 2013 (Actual)
Study Completion Date
January 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subarachnoid Hemorrhage
Keywords
Subarachnoid Hemorrhage, Seizure Prophylaxis, Levetiracetam

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brief LEV
Arm Type
Other
Arm Description
Administration of three days of levetiracetam twice daily after SAH
Arm Title
Extended LEV
Arm Type
Other
Arm Description
Administration of levetiracetam twice daily after SAH
Intervention Type
Other
Intervention Name(s)
Brief LEV
Intervention Description
Levetiracetam 1000mg BID x 3 days for prophylaxis
Intervention Type
Other
Intervention Name(s)
Extended LEV
Intervention Description
Levetiracetam 1000mg BID for length of hospital stay for prophylaxis
Primary Outcome Measure Information:
Title
In-hospital Seizures
Description
from admission to In-hospital seizures after aSAH
Time Frame
from hospital admission to hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >18 years of age Diagnosis of spontaneous SAH Exclusion Criteria: SAH secondary to trauma or arteriovenous malformation Early death (defined as death within 3 days of presentation) Known allergy to levetiracetam Know seizure history on chronic AEDs Pregnancy Current incarceration
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa Human-Murphy
Organizational Affiliation
Barnes-Jewish Hospital, Washington University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barnes-jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Short Duration Levetiracetam to Extended Course for Seizure Prophylaxis After aSAH

We'll reach out to this number within 24 hrs