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Comparison of Short Duration Levetiracetam to Extended Course for Seizure Prophylaxis After Subarachnoid Hemorrhage (SAH) (DOPAST)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Washington University School of Medicine.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Theresa Human-Murphy, Washington University School of Medicine Identifier:
First received: May 28, 2010
Last updated: March 21, 2012
Last verified: March 2012
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.

Condition Intervention Phase
Subarachnoid Hemorrhage
Drug: Levetiracetam short course
Drug: Levetiracetam Long course
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Comparison of Short Duration Levetiracetam to Extended Course Levetiracetam for Seizure Prophylaxis Following Subarachnoid Hemorrhage

Resource links provided by NLM:

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • In-hospital seizures after SAH [ Time Frame: 3-4 years ] [ Designated as safety issue: Yes ]
    We will compare two different lengths of levetiracetam therapy (3 days vs. hospital length) to determine if one is more efficacious in preventing seizures in patients after SAH.

Secondary Outcome Measures:
  • Compare incidence of seizure after hospital discharge and/or development of epilepsy [ Time Frame: 3-4 year ] [ Designated as safety issue: No ]
    Patient's will be followed to outpatient follow visits to determine incidence of seizures.

  • Compare incidence of adverse drug reactions related to levetiracetam and the rate of discontinuation of medication secondary to the reaction [ Time Frame: 3-4 years ] [ Designated as safety issue: Yes ]
  • Compare intensive care and hospital length of stay between regimens [ Time Frame: 3-4 year ] [ Designated as safety issue: Yes ]
  • Evaluate differences in cognitive and functional outcomes at discharge and outpatient follow-up [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Outcome measurements (mini mental, barthal index and CGOS) will be obtained at each follow up visit.

Estimated Enrollment: 460
Study Start Date: May 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Levetiracetam 1000mg BID for 3 days Drug: Levetiracetam short course
Levetiracetam 1000mg BID x 3 days
Active Comparator: Levetiracetam 1000mg BID x hospital stay Drug: Levetiracetam Long course
Levetiracetam 1000mg BID x hospital stay

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01137110

United States, Missouri
Barnes-jewish Hospital
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Principal Investigator: Theresa Human-Murphy Barnes-Jewish Hospital, Washington University
  More Information

Responsible Party: Theresa Human-Murphy, Dr., Washington University School of Medicine Identifier: NCT01137110     History of Changes
Other Study ID Numbers: 09-1717 
Study First Received: May 28, 2010
Last Updated: March 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Subarachnoid Hemorrhage
Seizure Prophylaxis

Additional relevant MeSH terms:
Subarachnoid Hemorrhage
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Intracranial Hemorrhages
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs processed this record on December 06, 2016