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Seizure Prophylaxis in Aneurysm Repair (SPAR)

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ClinicalTrials.gov Identifier: NCT01801072
Recruitment Status : Recruiting
First Posted : February 28, 2013
Last Update Posted : May 18, 2017
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Intracranial Aneurysms Seizure Drug: Levetiracetam Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Seizure Prophylaxis in Aneurysm Repair
Study Start Date : February 2013
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: Keppra
No Intervention: No levetiracetam
No levetiracetam

Outcome Measures

Primary Outcome Measures :
  1. Incidence of seizure [ Time Frame: 1 year from procedure ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01801072

Contact: Aditya Pandey, MD 734-615-4486 adityap@med.umich.edu
Contact: Ron Ball 734-647-5436 rmball@med.umich.edu

United States, Michigan
University of Michigan Health System Recruiting
Ann Arbor, Michigan, United States, 48109
Principal Investigator: Aditya Pandey, MD         
Sub-Investigator: Wajd Al-Holou, MD         
Sub-Investigator: Cormac Maher, MD         
Sub-Investigator: Christopher Roark, MD         
Sub-Investigator: William Stetler Jr, MD         
Sub-Investigator: Jennifer Strahle, MD         
Sub-Investigator: Byron Thompson, MD         
Sub-Investigator: TJ Wilson, MD         
Sponsors and Collaborators
University of Michigan
Principal Investigator: Aditya S Pandey, MD University of Michigan
More Information

Responsible Party: Aditya S. Pandey, MD, Assistant Professor of Neurosurgery and Assistant Professor of Radiology, Medical School, University of Michigan
ClinicalTrials.gov Identifier: NCT01801072     History of Changes
Other Study ID Numbers: HUM00064523
First Posted: February 28, 2013    Key Record Dates
Last Update Posted: May 18, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Intracranial Arterial Diseases
Cerebrovascular Disorders
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs