Trial Outcomes & Findings for Seizure Prophylaxis in Aneurysm Repair (NCT NCT01974700)
NCT ID: NCT01974700
Last Updated: 2016-03-11
Results Overview
Reported via patient in follow-up phone call.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
17 participants
Primary outcome timeframe
6 mo - 1 Year from Operative Procedure
Results posted on
2016-03-11
Participant Flow
While 17 were consented, 3 were screen failures, 5 were lost to follow up and one was withdrawn from the study.
Participant milestones
| Measure |
Levetiracetam
Levetiracetam: 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days
|
No Anti-epileptic Treatment
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
3
|
|
Overall Study
COMPLETED
|
5
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Seizure Prophylaxis in Aneurysm Repair
Baseline characteristics by cohort
| Measure |
Levetiracetam
n=5 Participants
Levetiracetam: 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days
|
No Anti-epileptic Treatment
n=3 Participants
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 mo - 1 Year from Operative ProcedureReported via patient in follow-up phone call.
Outcome measures
| Measure |
Levetiracetam
n=5 Participants
Levetiracetam: 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days
|
No Anti-epileptic Treatment
n=3 Participants
|
|---|---|---|
|
Incidence of Seizure
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 6 months - 12 monthsThe number who had returned to daily activities in the timeframe of 6-12 months, inclusion of those that returned to most of daily activities.
Outcome measures
| Measure |
Levetiracetam
n=5 Participants
Levetiracetam: 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days
|
No Anti-epileptic Treatment
n=3 Participants
|
|---|---|---|
|
Number of Participants Who Returned to Daily Activities.
|
5 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 6 months - 12 monthsThe number who had returned to work in the timeframe of 6-12 months, inclusion of those that returned to part-time.
Outcome measures
| Measure |
Levetiracetam
n=5 Participants
Levetiracetam: 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days
|
No Anti-epileptic Treatment
n=3 Participants
|
|---|---|---|
|
Number of Participants Who Returned to Work
|
1 participants
|
1 participants
|
Adverse Events
Levetiracetam
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
No Anti-epileptic Treatment
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Levetiracetam
n=5 participants at risk
Levetiracetam: 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days
|
No Anti-epileptic Treatment
n=3 participants at risk
|
|---|---|---|
|
Nervous system disorders
rehospitalization for seizures
|
0.00%
0/5 • within 1 year
|
33.3%
1/3 • within 1 year
|
|
Nervous system disorders
benzodiazepine withdrawal rehospitalization
|
20.0%
1/5 • within 1 year
|
0.00%
0/3 • within 1 year
|
Other adverse events
| Measure |
Levetiracetam
n=5 participants at risk
Levetiracetam: 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days
|
No Anti-epileptic Treatment
n=3 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
nausea
|
20.0%
1/5 • within 1 year
|
0.00%
0/3 • within 1 year
|
|
General disorders
itching
|
20.0%
1/5 • within 1 year
|
0.00%
0/3 • within 1 year
|
|
Injury, poisoning and procedural complications
intraoperative rupture
|
0.00%
0/5 • within 1 year
|
33.3%
1/3 • within 1 year
|
|
Nervous system disorders
partial seizures
|
0.00%
0/5 • within 1 year
|
33.3%
1/3 • within 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place