Trial Outcomes & Findings for Seizure Prophylaxis in Aneurysm Repair (NCT NCT01801072)

NCT ID: NCT01801072

Last Updated: 2024-11-29

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 82 participants
• Primary outcome timeframe: 5 years from procedure
• Results posted on: 2024-11-29

Participant Flow

Participant milestones

Measure	Levetiracetam 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days. Levetiracetam: Details covered in Arm Descriptions.	No Levetiracetam No levetiracetam during the operative phase.
Overall Study STARTED	40	42
Overall Study Hospitalization	35	39
Overall Study COMPLETED	11	17
Overall Study NOT COMPLETED	29	25

Reasons for withdrawal

Measure	Levetiracetam 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days. Levetiracetam: Details covered in Arm Descriptions.	No Levetiracetam No levetiracetam during the operative phase.
Overall Study Lost to Follow-up	17	14
Overall Study Physician Decision	2	3
Overall Study Withdrawal by Subject	1	0
Overall Study Protocol Violation	2	0
Overall Study Death	7	8

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Levetiracetam n=40 Participants 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days. Levetiracetam: Details covered in Arm Descriptions.	No Levetiracetam n=42 Participants No levetiracetam during the operative phase.	Total n=82 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=40 Participants	0 Participants n=42 Participants	0 Participants n=82 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=40 Participants	34 Participants n=42 Participants	65 Participants n=82 Participants
Age, Categorical >=65 years	9 Participants n=40 Participants	8 Participants n=42 Participants	17 Participants n=82 Participants
Sex: Female, Male Female	27 Participants n=40 Participants	30 Participants n=42 Participants	57 Participants n=82 Participants
Sex: Female, Male Male	13 Participants n=40 Participants	12 Participants n=42 Participants	25 Participants n=82 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	40 Participants n=40 Participants	42 Participants n=42 Participants	82 Participants n=82 Participants

PRIMARY outcome

Timeframe: 5 years from procedure

Population: 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.

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.

Outcome measures

Measure	Levetiracetam n=40 Participants 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days. Levetiracetam: Details covered in Arm Descriptions.	No Levetiracetam n=42 Participants No levetiracetam during the operative phase.
Incidence of Seizure Hospitalization	2 Participants	1 Participants
Incidence of Seizure 1-2 Months	0 Participants	0 Participants
Incidence of Seizure 4-6 Months	0 Participants	0 Participants
Incidence of Seizure 6-12 Months	0 Participants	0 Participants
Incidence of Seizure 5 years	1 Participants	2 Participants

SECONDARY outcome

Timeframe: To compare duration of seizure in each randomization group

Population: While this was originally intended to be a measure collected for this study, the unpredictability of seizure occurrences and the consequent challenges with observing them consistently resulted in our being unable to collect this data from participants.

Duration of seizure

Outcome measures

Outcome data not reported

Adverse Events

Levetiracetam

Serious events: 2 serious events

Other events: 7 other events

Deaths: 7 deaths

No Levetiracetam

Serious events: 2 serious events

Other events: 3 other events

Deaths: 8 deaths

Serious adverse events

Measure	Levetiracetam n=40 participants at risk 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days. Levetiracetam: Details covered in Arm Descriptions.	No Levetiracetam n=42 participants at risk No levetiracetam during the operative phase.
Eye disorders Acute Right Vision Loss	0.00% 0/40 • 5 years	2.4% 1/42 • Number of events 1 • 5 years
Vascular disorders Stroke	5.0% 2/40 • 5 years	2.4% 1/42 • 5 years

Other adverse events

Measure	Levetiracetam n=40 participants at risk 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days. Levetiracetam: Details covered in Arm Descriptions.	No Levetiracetam n=42 participants at risk No levetiracetam during the operative phase.
Nervous system disorders Unexplained Encephalopathy	2.5% 1/40 • 5 years	0.00% 0/42 • 5 years
Nervous system disorders Headache	2.5% 1/40 • 5 years	0.00% 0/42 • 5 years
Nervous system disorders Delirium	2.5% 1/40 • 5 years	0.00% 0/42 • 5 years
Product Issues Patient received extra Keppra	2.5% 1/40 • 5 years	0.00% 0/42 • 5 years
Nervous system disorders Seizure	7.5% 3/40 • 5 years	7.1% 3/42 • 5 years

Additional Information

Dr. Aditya Pandey, Chair, Department of Neurosurgery

University of Michigan

Phone: 734-936-7010

Email: adityap@umich.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place