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Seizure Prophylaxis in Aneurysm Repair (SPAR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2013 by University of Michigan.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Aditya S. Pandey, MD, University of Michigan Health System
ClinicalTrials.gov Identifier:
NCT01801072
First received: February 26, 2013
Last updated: February 27, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention Phase
Intracranial Aneurysms
Seizure
 Drug: Levetiracetam
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Seizure Prophylaxis in Aneurysm Repair

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Incidence of seizure [ Time Frame: 1 year from procedure ] [ Designated as safety issue: Yes ]
Estimated Enrollment: 400
Study Start Date: February 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01801072

Contacts
Contact: Aditya Pandey, MD 734-615-4486

Locations
United States, Michigan
University of Michigan Health System Recruiting
Ann Arbor, Michigan, United States, 48109
Principal Investigator: Aditya Pandey, MD         
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Aditya S Pandey, MD University of Michigan
  More Information

No publications provided

Responsible Party: Aditya S. Pandey, MD, Assistant Professor of Neurosurgery and Assistant Professor of Radiology, Medical School, University of Michigan Health System
ClinicalTrials.gov Identifier: NCT01801072     History of Changes
Other Study ID Numbers: HUM00064523
Study First Received: February 26, 2013
Last Updated: February 27, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Epilepsy
Aneurysm
Intracranial Aneurysm
Seizures
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Intracranial Arterial Diseases
Nervous System Diseases
 Neurologic Manifestations
Signs and Symptoms
Vascular Diseases
Etiracetam
Anticonvulsants
Central Nervous System Agents
Nootropic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015