Trial Outcomes & Findings for Short Duration Levetiracetam to Extended Course for Seizure Prophylaxis After aSAH (NCT NCT01137110)

NCT ID: NCT01137110

Last Updated: 2019-07-12

Results Overview

from admission to In-hospital seizures after aSAH

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 84 participants
• Primary outcome timeframe: from hospital admission to hospital discharge
• Results posted on: 2019-07-12

Participant Flow

All patients enrolled were assigned to a treatment group.

Participant milestones

Measure	Levetiracetam 1000mg BID for 3 Days Levetiracetam short course: Levetiracetam 1000mg BID x 3 days This cohort will receive three days of Levetiracetam twice daily for seizure prophylaxis. They will be followed for the entire hospital stay for incidence of seizures. If a seizure occurs, the treating physician will treat per usual therapies. Functional status will be assessed at the patients outpatient follow up if available.	Levetiracetam 1000mg BID x Hospital Stay Levetiracetam Long course: Levetiracetam 1000mg BID x hospital stay This cohort will receive Levetiracetam for the entire length of hospital stay. They will be closely followed for both incidence of seizures as well as adverse effects of the medication. Functional status will be assessed at the patients outpatient follow up if available.
Overall Study STARTED	35	49
Overall Study COMPLETED	34	49
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Levetiracetam 1000mg BID for 3 Days Levetiracetam short course: Levetiracetam 1000mg BID x 3 days This cohort will receive three days of Levetiracetam twice daily for seizure prophylaxis. They will be followed for the entire hospital stay for incidence of seizures. If a seizure occurs, the treating physician will treat per usual therapies. Functional status will be assessed at the patients outpatient follow up if available.	Levetiracetam 1000mg BID x Hospital Stay Levetiracetam Long course: Levetiracetam 1000mg BID x hospital stay This cohort will receive Levetiracetam for the entire length of hospital stay. They will be closely followed for both incidence of seizures as well as adverse effects of the medication. Functional status will be assessed at the patients outpatient follow up if available.
Overall Study Protocol Violation	1	0

Baseline Characteristics

Short Duration Levetiracetam to Extended Course for Seizure Prophylaxis After aSAH

Baseline characteristics by cohort

Measure	Brief LEV n=35 Participants 3 days of LEV 1000mg after aSAH	Extended LEV n=49 Participants LEV for hospital stay after aSAH	Total n=84 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	32 Participants n=5 Participants	45 Participants n=7 Participants	77 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	32 Participants n=7 Participants	55 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	17 Participants n=7 Participants	29 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants	39 Participants n=7 Participants	64 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: from hospital admission to hospital discharge

from admission to In-hospital seizures after aSAH

Outcome measures

Measure	Brief LEV n=35 Participants In-hospital seizure in patient receiving 3 days of LEV compared to Extended LEV that received LEV for length of hospital stay.	Extended LEV n=49 Participants In-hospital seizure in patient receiving 3 days of LEV compared to Extended LEV that received LEV for length of hospital stay.
In-hospital Seizures	3 Participants	1 Participants

Adverse Events

Brief LEV

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Extended LEV

Serious events: 4 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Brief LEV n=35 participants at risk ADR requiring discontinuation	Extended LEV n=49 participants at risk ADR requiring discontinue
Nervous system disorders Sedation	0.00% 0/35 • from admission, daily until hosptial discharge.	8.2% 4/49 • Number of events 4 • from admission, daily until hosptial discharge.

Other adverse events

Measure	Brief LEV n=35 participants at risk ADR requiring discontinuation	Extended LEV n=49 participants at risk ADR requiring discontinue
Immune system disorders thrombocytopenia	0.00% 0/35 • from admission, daily until hosptial discharge.	2.0% 1/49 • Number of events 1 • from admission, daily until hosptial discharge.

Additional Information

Dr Theresa Human

Washington University

Phone: 314-747-8799

Email: theresa.human@bjc.org

Results disclosure agreements

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