Intracranial AneurysmsPhase 4SPARNCT01801072

Seizure Prophylaxis in Aneurysm Repair

A Phase 4 study testing Levetiracetam in people with Intracranial Aneurysms and Seizure, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Intracranial Aneurysms, Seizure
What is being tested?: Levetiracetam
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 82 participants
Where: 1 siteUnited States
Study dates: Feb 2013to 6 Oct 2023
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan Health System
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

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
Being tested: Levetiracetam
Medical subject headings: Intracranial Aneurysm, Seizures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LevetiracetamDrug
Also called Keppra
Details covered in Arm Descriptions.

Study groups in NCT01801072
Study group	Role	What they receive
Levetiracetam	Active comparator	500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days. Receives: Drug: Levetiracetam
No levetiracetam	No intervention	No levetiracetam during the operative phase.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 5 years from procedure

Secondary outcomes (1)

Duration of Seizure
Duration of seizure
Measured: To compare duration of seizure in each randomization group

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 20136 Oct 2023

First posted28 Feb 2013 (estimated)
Study startFeb 2013
Primary completion6 Oct 2023
Study completion6 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Intracranial AneurysmsStudies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 82 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01801072
Sponsor's protocol ID: HUM00064523
Acronym: SPAR
Status last verified: Nov 2024
First submitted: 26 Feb 2013
Last updated: 29 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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China Treatment Trial for Tumor in Sellar Region With Unruptured Intracranial Aneurysm
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Safety and Efficacy of Endovascular Treatment of Intracranial Aneurysms With Surpass Elite With GUARDian Flow Diverter (GUARD)
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All Intracranial Aneurysms trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Seizure Prophylaxis in Aneurysm Repair
ClinicalTrials.gov ID: NCT01801072
Acronym / sponsor ID: SPAR / HUM00064523
Conditions: Intracranial Aneurysms, Seizure
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 82 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Study start: Feb 2013 (actual)
Primary completion: 6 Oct 2023 (actual)
Study completion: 6 Oct 2023 (actual)
First posted: 28 Feb 2013 (estimated)
Results: Posted 29 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Levetiracetam	Active comparator	Drug: Levetiracetam500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days.
No levetiracetam	No intervention	–No levetiracetam during the operative phase.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LevetiracetamAlso: KeppraDetails covered in Arm Descriptions.	Drug	Levetiracetam

Primary outcome

Incidence of Seizure
Time frame: 5 years from procedure
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.

1 secondary outcome

Duration of Seizure
Time frame: To compare duration of seizure in each randomization group

Results and safety

Results posted to the registry on 29 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Levetiracetam	40	11
No Levetiracetam	42	17

Primary outcome: Incidence of Seizure

Time frame: 5 years from procedure. Count of participants. Unit: Participants

Measure	Levetiracetam n = 40	No Levetiracetam n = 42
Hospitalization	2	1
1-2 Months	0	0
4-6 Months	0	0
6-12 Months	0	0
5 years	1	2

Population analysed: The number of participants analyzed differs from the totals enrolled as some subjects withdrew consent after randomization or were taken out of the study due to physician decision.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 5 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Levetiracetam	2 of 40 (5%)	7 of 40 (17.5%)	7 of 40
No Levetiracetam	2 of 42 (4.8%)	3 of 42 (7.1%)	8 of 42

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Intracranial Aneurysms

RecruitingObservational study
Prospective Observational Cohort Study for Predicting Unruptured Intracranial Aneurysm Rupture Risk Using Blood Pressure Variability and 3D Structural Evolution
Unruptured Intracranial Aneurysm, Intracranial Aneurysm Rupture
Not yet recruitingPhase 4
Efficacy and Safety of Methylprednisolone After Flow-Diverter Stent Implantation in Unruptured Intracranial Aneurysms
Unruptured Intracranial Aneurysms, Cerebrovascular Event
RecruitingObservational study
NV PSR INSPIRE-A Pipeline™ Vantage Post Approval Study
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Active, not recruitingObservational study
China Treatment Trial for Tumor in Sellar Region With Unruptured Intracranial Aneurysm
Unruptured Intracranial Aneurysms, Pituitary Neuroendocrine Tumor
Recruiting
Safety and Efficacy of Endovascular Treatment of Intracranial Aneurysms With Surpass Elite With GUARDian Flow Diverter (GUARD)
Aneurysm, Aneurysm, Intracranial

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Aditya S Pandey, MD principal investigator

University of Michigan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Levetiracetam in people with Intracranial Aneurysms and Seizure, run by University of Michigan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Seizure (time frame: 5 years from procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01801072.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.