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
|Condition or disease||Intervention/treatment||Phase|
|Subarachnoid Hemorrhage||Drug: Levetiracetam short course Drug: Levetiracetam Long course||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|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
- 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.
- 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.
- 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 ]
- Compare intensive care and hospital length of stay between regimens [ Time Frame: 3-4 year ]
- 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.
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
|United States, Missouri|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Theresa Human-Murphy||Barnes-Jewish Hospital, Washington University|