Seizure Prophylaxis in Aneurysm Repair (SPAR)
Primary Purpose
Intracranial Aneurysms, Seizure
Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Levetiracetam
Sponsored by
About this trial
This is an interventional supportive care trial for Intracranial Aneurysms
Eligibility Criteria
Inclusion Criteria:
- Adult (≥18 years)
- Presence of intracranial aneurysm (with or 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
- University of Michigan Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Levetiracetam
No levetiracetam
Arm Description
500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days.
No levetiracetam
Outcomes
Primary Outcome Measures
Incidence of seizure
Incidence of seizure - data collected at 2 months, 6 months, 12 months, and 5 years.
Secondary Outcome Measures
Full Information
NCT ID
NCT01801072
First Posted
February 26, 2013
Last Updated
October 9, 2023
Sponsor
University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT01801072
Brief Title
Seizure Prophylaxis in Aneurysm Repair
Acronym
SPAR
Official Title
Seizure Prophylaxis in Aneurysm Repair
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 2013 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
After a thorough review of the existing literature as well as a review of our own practice, the investigators have concluded that the decision to treat patients undergoing aneurysm repair with levetiracetam has reached true clinical equipoise. In other words, the investigators cannot favor a decision to either administer or not administer this drug in these patients based on the existing information. The utility of anti-epileptic prophlaxis in the perioperative period for patients undergoing intracranial aneurysm repair remains a common practice that is not supported by the current literature that includes retrospective analyses as well as prospective trials for similar but not identical types of patients. The investigators propose to settle this dilemma by performing a prospective randomized trial in patients undergoing aneurysm repair in order to definitively determine if the common practice of perioperative antiepileptic drug administration has any utility. The study will be extended to June 2024 to allow for a 5 year follow up of the last enrolled patient in June, 2019.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Aneurysms, Seizure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Levetiracetam
Arm Type
Active Comparator
Arm Description
500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days.
Arm Title
No levetiracetam
Arm Type
No Intervention
Arm Description
No levetiracetam
Intervention Type
Drug
Intervention Name(s)
Levetiracetam
Other Intervention Name(s)
Keppra
Intervention Description
Details covered in Arm Descriptions.
Primary Outcome Measure Information:
Title
Incidence of seizure
Description
Incidence of seizure - data collected at 2 months, 6 months, 12 months, and 5 years.
Time Frame
5 years from procedure
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 (with or 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aditya S Pandey, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Seizure Prophylaxis in Aneurysm Repair
We'll reach out to this number within 24 hrs