Short Duration Levetiracetam to Extended Course for Seizure Prophylaxis After aSAH
DOPAST
Comparison of Short Duration Levetiracetam to Extended Course Levetiracetam for Seizure Prophylaxis Following Subarachnoid Hemorrhage
1 other identifier
interventional
84
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 28, 2010
CompletedFirst Posted
Study publicly available on registry
June 4, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedResults Posted
Study results publicly available
July 12, 2019
CompletedJuly 12, 2019
April 1, 2019
2.7 years
May 28, 2010
January 30, 2018
April 29, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
In-hospital Seizures
from admission to In-hospital seizures after aSAH
from hospital admission to hospital discharge
Study Arms (2)
Brief LEV
OTHERAdministration of three days of levetiracetam twice daily after SAH
Extended LEV
OTHERAdministration of levetiracetam twice daily after SAH
Interventions
Eligibility Criteria
You may qualify if:
- Age \>18 years of age
- Diagnosis of spontaneous SAH
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Barnes-jewish Hospital
St Louis, Missouri, 63110, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
We were unable to achieve our target sample size due to slow enrollment. Secondly, the study was not blinded for the primary outcome which could introduce bias.
Results Point of Contact
- Title
- Dr Theresa Human
- Organization
- Washington University
Study Officials
- PRINCIPAL INVESTIGATOR
Theresa Human-Murphy
Barnes-Jewish Hospital, Washington University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
May 28, 2010
First Posted
June 4, 2010
Study Start
May 1, 2010
Primary Completion
January 1, 2013
Study Completion
January 1, 2017
Last Updated
July 12, 2019
Results First Posted
July 12, 2019
Record last verified: 2019-04