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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Theresa Human-Murphy, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01137110
First received: May 28, 2010
Last updated: March 21, 2012
Last verified: March 2012
  Purpose

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01137110

Contacts
Contact: Theresa Human-Murphy 314-747-8799 txm5120@bjc.org
Contact: Rajat Dhar 314-632-2508 dharr@neuro.wustl.edu

Locations
United States, Missouri
Barnes-jewish Hospital Recruiting
St. Louis, Missouri, United States, 63110
Contact: Theresa Human-Murphy    314-747-8799    txm5120@bjc.org   
Contact: Rajat Dhar, MD    314-632-2508    dharr@neuro.wustl.edu   
Principal Investigator: Theresa Human-Murphy         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Theresa Human-Murphy Barnes-Jewish Hospital, Washington University
  More Information

No publications provided

Responsible Party: Theresa Human-Murphy, Dr., Washington University School of Medicine
ClinicalTrials.gov 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
Levetiracetam

Additional relevant MeSH terms:
Seizures
Hemorrhage
Subarachnoid Hemorrhage
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Etiracetam
Piracetam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014