CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 82 enrolled
Drug / intervention
Levetiracetamdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01801072
NCT01801072Phase 4Completed

Seizure Prophylaxis in Aneurysm Repair

University of Michigan·interventional·Posted Feb 28, 2013·Updated Nov 29, 2024

In Brief

A Phase 4 clinical trial evaluating Levetiracetam for Intracranial Aneurysms and Seizure. Completed, enrolled 82 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 28, 2013
Enrollment StartFeb 1, 2013
Primary CompletionOct 6, 2023
TodayJul 2, 2026
Enrollment to primary: 10.7 yearsPosted 13.3 years ago

Interventions

Levetiracetamdrug

Details covered in Arm Descriptions.