Seizure Prophylaxis in Aneurysm Repair

NCT01801072 | Completed Phase 4 Results FDA Drug

• 1 other identifier: HUM00064523
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracranial Aneurysms; Seizure

Outcome Measures

Primary Outcomes (1)

• Incidence of Seizure

  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.

  5 years from procedure

Secondary Outcomes (1)

• Duration of Seizure

  To compare duration of seizure in each randomization group

Study Arms (2)

Levetiracetam

ACTIVE COMPARATOR

500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days.

Drug: Levetiracetam

No levetiracetam

NO INTERVENTION

No levetiracetam during the operative phase.

Interventions

Levetiracetam DRUG

Details covered in Arm Descriptions.

Also known as: Keppra

Levetiracetam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (≥18 years)
• Presence of intracranial aneurysm (with or without rupture)
• Treating surgeon has recommended surgical repair of the aneurysm

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Intracranial Aneurysm; Seizures

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Aditya Pandey, Chair, Department of Neurosurgery
• Organization: University of Michigan

adityap@umich.edu

734-936-7010

Study Officials

• Aditya S Pandey, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurosurgery, Chair, Department of Neurosurgery, Professor of Radiology

Study Record Dates

• First Submitted: February 26, 2013
• First Posted: February 28, 2013
• Study Start: February 1, 2013
• Primary Completion: October 6, 2023
• Study Completion: October 6, 2023
• Last Updated: November 29, 2024
• Results First Posted: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)