SPAR: Seizure Prophylaxis in Aneurysm Repair

• Sponsor: University of Michigan (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT01801072
• Collaborator: (none)
• Enrollment: 79
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 136
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Intracranial Aneurysms; Seizure	Drug: Levetiracetam	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 79 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Seizure Prophylaxis in Aneurysm Repair
• Actual Study Start Date: Feb 1, 2013
• Anticipated Primary Completion Date: Jun 1, 2024
• Anticipated Study Completion Date: Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Levetiracetam 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days.	Drug: Levetiracetam; Details covered in Arm Descriptions.; Other Names: Keppra
No Intervention: No levetiracetam No levetiracetam

Outcome Measures

Primary Outcome Measures

1. Incidence of seizure [5 years from procedure]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan Health System	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

• University of Michigan

Investigators

• Principal Investigator: Aditya S Pandey, MD, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aditya S. Pandey, MD, Assistant Professor of Neurosurgery and Assistant Professor of Radiology, Medical School, University of Michigan
• ClinicalTrials.gov Identifier: NCT01801072
• Other Study ID Numbers: HUM00064523
• First Posted: Feb 28, 2013
• Last Update Posted: Oct 12, 2021
• Last Verified: Oct 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Seizures; Intracranial Aneurysm; Aneurysm; Levetiracetam

Study Results

No Results Posted as of Oct 12, 2021