Seizure Prophylaxis in Aneurysm Repair

Seizures Clinical Trial

Official title:

Seizure Prophylaxis in Aneurysm Repair

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01974700
• Other study ID #: GCBS-0001
• Status: Terminated
• Phase: Phase 4
• First received: October 28, 2013
• Last updated: March 7, 2016
• Start date: July 2013
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Seizures are a potential complication of surgical repair of intracranial aneurysms. In order to prevent seizures, many surgeons administer prophylactic anti-epileptic medication during the intra-operative and post-operative period, however, such practice is not supported by clinical data. Retrospective review found the incidence of postoperative seizures was higher in those who received anti-epileptics versus those who did not. The goal is to examine the utility of levetiracetam (Keppra) for seizure prophylaxis in patients undergoing surgical repair of unruptured intracranial aneurysms.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adult (=18 years)

2. Presence of intracranial aneurysm (without rupture)

3. Treating surgeon has recommended surgical repair of the aneurysm.

Exclusion Criteria:

1. History of seizures within last 10 years

2. History of epilepsy

3. History of prior stroke

4. Currently prescribed medication with anti-epileptic activity (keppra,dilantin, tegretol, lamictal, topamax, etc.)

5. Brain tumor

6. Pregnant or nursing woman

7. Known levetiracetam allergy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Intracranial Aneurysms
• Seizures

Intervention

Drug:
• Levetiracetam
500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days

Locations

Country	Name	City	State
United States	IU Health Methodist Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Seizure	Reported via patient in follow-up phone call.	6 mo - 1 Year from Operative Procedure	Yes
Secondary	Number of Participants Who Returned to Daily Activities.	The number who had returned to daily activities in the timeframe of 6-12 months, inclusion of those that returned to most of daily activities.	6 months - 12 months	No
Secondary	Number of Participants Who Returned to Work	The number who had returned to work in the timeframe of 6-12 months, inclusion of those that returned to part-time.	6 months - 12 months	No