ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 13 for:    epilepsy Michigan | Recruiting, Not yet recruiting, Available Studies
Previous Study | Return to List | Next Study

Seizure Prophylaxis in Aneurysm Repair (SPAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01801072
Recruitment Status : Recruiting
First Posted : February 28, 2013
Last Update Posted : February 27, 2018
Sponsor:
Information provided by (Responsible Party):
Aditya S. Pandey, MD, University of Michigan

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 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 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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


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

Locations
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
Investigators
Principal Investigator: Aditya S Pandey, MD University of Michigan

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: February 27, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Epilepsy
Aneurysm
Seizures
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
Etiracetam
Piracetam
Anticonvulsants
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs