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
: February 27, 2018
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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 |

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
|
- Incidence of seizure [ Time Frame: 1 year from procedure ]

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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

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 |
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 |