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

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ClinicalTrials.gov Identifier: NCT01137110
Recruitment Status : Completed
First Posted : June 4, 2010
Last Update Posted : January 31, 2018
Sponsor:
Information provided by (Responsible Party):
Theresa Human-Murphy, Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Subarachnoid Hemorrhage Drug: Levetiracetam short course Drug: Levetiracetam Long course Phase 3

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  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparison of Short Duration Levetiracetam to Extended Course Levetiracetam for Seizure Prophylaxis Following Subarachnoid Hemorrhage
Actual Study Start Date : May 1, 2010
Actual Primary Completion Date : January 1, 2013
Actual Study Completion Date : January 1, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. In-hospital seizures after SAH [ Time Frame: 3-4 years ]
    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 :
  1. Compare incidence of seizure after hospital discharge and/or development of epilepsy [ Time Frame: 3-4 year ]
    Patient's will be followed to outpatient follow visits to determine incidence of seizures.

  2. 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 ]
  3. Compare intensive care and hospital length of stay between regimens [ Time Frame: 3-4 year ]
  4. Evaluate differences in cognitive and functional outcomes at discharge and outpatient follow-up [ Time Frame: 5 years ]
    Outcome measurements (mini mental, barthal index and CGOS) will be obtained at each follow up visit.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01137110


Locations
United States, Missouri
Barnes-jewish Hospital
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Theresa Human-Murphy Barnes-Jewish Hospital, Washington University

Responsible Party: Theresa Human-Murphy, Dr., Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01137110     History of Changes
Other Study ID Numbers: 09-1717
First Posted: June 4, 2010    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018

Keywords provided by Theresa Human-Murphy, Washington University School of Medicine:
Subarachnoid Hemorrhage
Seizure Prophylaxis
Levetiracetam

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