Back to resultsSeizure Prophylaxis in Aneurysm Repair
Primary Purpose
Intracranial Aneurysms, Seizures
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Levetiracetam
Sponsored by
About this trial
This is an interventional treatment trial for Intracranial Aneurysms
Eligibility Criteria
Inclusion Criteria:
- Adult (≥18 years)
- Presence of intracranial aneurysm (without rupture)
- Treating surgeon has recommended surgical repair of the aneurysm.
Exclusion Criteria:
- History of seizures within last 10 years
- History of epilepsy
- History of prior stroke
- Currently prescribed medication with anti-epileptic activity (keppra,dilantin, tegretol, lamictal, topamax, etc.)
- Brain tumor
- Pregnant or nursing woman
- Known levetiracetam allergy
Sites / Locations
- IU Health Methodist Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Levetiracetam
No anti-epileptic treatment
Arm Description
Outcomes
Primary Outcome Measures
Incidence of Seizure
Reported via patient in follow-up phone call.
Secondary Outcome Measures
Number of Participants Who Returned to Daily Activities.
The number who had returned to daily activities in the timeframe of 6-12 months, inclusion of those that returned to most of daily activities.
Number of Participants Who Returned to Work
The number who had returned to work in the timeframe of 6-12 months, inclusion of those that returned to part-time.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01974700
Brief Title
Seizure Prophylaxis in Aneurysm Repair
Official Title
Seizure Prophylaxis in Aneurysm Repair
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Why Stopped
Lack of enrollment - since the start of the study in 2013, only 17 subjects have consented. Of those, only 8 completed the study.
Study Start Date
July 2013 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indiana University
4. Oversight
5. Study Description
Brief Summary
Seizures are a potential complication of surgical repair of intracranial aneurysms. In order to prevent seizures, many surgeons administer prophylactic anti-epileptic medication during the intra-operative and post-operative period, however, such practice is not supported by clinical data. Retrospective review found the incidence of postoperative seizures was higher in those who received anti-epileptics versus those who did not. The goal is to examine the utility of levetiracetam (Keppra) for seizure prophylaxis in patients undergoing surgical repair of unruptured intracranial aneurysms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Aneurysms, Seizures
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Levetiracetam
Arm Type
Active Comparator
Arm Title
No anti-epileptic treatment
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Levetiracetam
Intervention Description
500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days
Primary Outcome Measure Information:
Title
Incidence of Seizure
Description
Reported via patient in follow-up phone call.
Time Frame
6 mo - 1 Year from Operative Procedure
Secondary Outcome Measure Information:
Title
Number of Participants Who Returned to Daily Activities.
Description
The number who had returned to daily activities in the timeframe of 6-12 months, inclusion of those that returned to most of daily activities.
Time Frame
6 months - 12 months
Title
Number of Participants Who Returned to Work
Description
The number who had returned to work in the timeframe of 6-12 months, inclusion of those that returned to part-time.
Time Frame
6 months - 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult (≥18 years)
Presence of intracranial aneurysm (without rupture)
Treating surgeon has recommended surgical repair of the aneurysm.
Exclusion Criteria:
History of seizures within last 10 years
History of epilepsy
History of prior stroke
Currently prescribed medication with anti-epileptic activity (keppra,dilantin, tegretol, lamictal, topamax, etc.)
Brain tumor
Pregnant or nursing woman
Known levetiracetam allergy
Facility Information:
Facility Name
IU Health Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Seizure Prophylaxis in Aneurysm Repair
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