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NCT01801072 · ClinicalTrials.gov registry record · Phase 4
Seizure Prophylaxis in Aneurysm Repair
A Phase 4 study of Seizure and Intracranial Aneurysms, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 4
- Development phase
- 82
- Enrollment target
- 1
- Study location
NCT01801072: Completed Phase 4 study of Seizure and Intracranial Aneurysms, sponsored by University of Michigan.
NCT01801072 is a Phase 4 study of Seizure and Intracranial Aneurysms that has completed, run by University of Michigan. The registered enrollment target is 82 participants, below the 103-participant average among 5 other Seizure trials with a reported enrollment target (20% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01801072, a Phase 4 study of Seizure and Intracranial Aneurysms, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 82 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Incidence of seizure reported as number of participants who had at least one seizure within the relevant date range. Data collected at hospital discharge, 1-2 months, 4-6 months, 6-12 months, and 5 years. Data is not cumulative. Counts reflect the number of participants who experienced a seizure since their previous check-in.
Conditions Studied
Interventions
- DRUG Levetiracetam
Study Locations (1)
Michigan
- University of Michigan Health System - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2013-02 |
| Est. Completion | 2023-10-06 |
| Phase | Phase 4 |
What the finished NCT01801072 record still lists
NCT01801072 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 103-participant average among 5 other Seizure trials with a reported enrollment target (20% lower).
The record links to 2 conditions, with Seizure appearing as the primary indexed condition, and to 1 intervention - of which Levetiracetam is the first listed.
NCT01801072 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT01801072 about?
NCT01801072 is a clinical study titled "Seizure Prophylaxis in Aneurysm Repair". 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 decisio...
What is the current status of trial NCT01801072?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 82 participants. The study started on 2013-02. Estimated completion is 2023-10-06.
What conditions does trial NCT01801072 study?
This clinical trial studies the following conditions: Seizure, Intracranial Aneurysms.
What interventions are being tested in trial NCT01801072?
The interventions under investigation include: Levetiracetam (DRUG).
Who is sponsoring clinical trial NCT01801072?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01801072 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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