Trial Outcomes & Findings for IV Keppra in the Emergency Department for Prevention of Early Recurrent Seizures (NCT NCT00510783)

NCT ID: NCT00510783

Last Updated: 2013-12-12

Results Overview

Recurrent seizure is defined as a seizure within 24 hours of treatment in the Emergency Department.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 158 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2013-12-12

Participant Flow

Study completed

study completed

Participant milestones

Measure	Phenytoin/Fosphenytoin Patients in the control arm will receive either IV Dilantin (1 gram of IV phenytoin infused at 25 mg/min or slower depending on vitals) or IV Fosphenytoin (1 gram of IV Fosphenytoin infused at 15 mg/min or slower depending on vitals).	Levetiracetam Patients in the intervention arm will receive IV Keppra (1 gram of Keppra added to 100 mL diluent infused over 15 minutes).
Overall Study STARTED	82	76
Overall Study COMPLETED	51	47
Overall Study NOT COMPLETED	31	29

Reasons for withdrawal

Measure	Phenytoin/Fosphenytoin Patients in the control arm will receive either IV Dilantin (1 gram of IV phenytoin infused at 25 mg/min or slower depending on vitals) or IV Fosphenytoin (1 gram of IV Fosphenytoin infused at 15 mg/min or slower depending on vitals).	Levetiracetam Patients in the intervention arm will receive IV Keppra (1 gram of Keppra added to 100 mL diluent infused over 15 minutes).
Overall Study Lost to Follow-up	29	25
Overall Study Withdrawal by Subject	2	3
Overall Study Protocol Violation	0	1

Baseline Characteristics

IV Keppra in the Emergency Department for Prevention of Early Recurrent Seizures

Baseline characteristics by cohort

Measure	Phenytoin/Fosphenytoin n=82 Participants Patients in the control arm will receive either IV Dilantin (1 gram of IV phenytoin infused at 25 mg/min or slower depending on vitals) or IV Fosphenytoin (1 gram of IV Fosphenytoin infused at 15 mg/min or slower depending on vitals).	Levetiracetam n=76 Participants Patients in the intervention arm will receive IV Keppra (1 gram of Keppra added to 100 mL diluent infused over 15 minutes).	Total n=158 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	80 Participants n=5 Participants	73 Participants n=7 Participants	153 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Age Continuous	51.80 years STANDARD_DEVIATION 106.459 • n=5 Participants	65.79 years STANDARD_DEVIATION 154.721 • n=7 Participants	58.53 years STANDARD_DEVIATION 131.651 • n=5 Participants
Sex: Female, Male Female	56 Participants n=5 Participants	53 Participants n=7 Participants	109 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	23 Participants n=7 Participants	49 Participants n=5 Participants
Region of Enrollment United States	82 participants n=5 Participants	76 participants n=7 Participants	158 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

Recurrent seizure is defined as a seizure within 24 hours of treatment in the Emergency Department.

Outcome measures

Measure	Phenytoin/Fosphenytoin n=82 Participants Patients in the control arm will receive either IV Dilantin (1 gram of IV phenytoin infused at 25 mg/min or slower depending on vitals) or IV Fosphenytoin (1 gram of IV Fosphenytoin infused at 15 mg/min or slower depending on vitals).	Levetiracetam n=76 Participants Patients in the intervention arm will receive IV Keppra (1 gram of Keppra added to 100 mL diluent infused over 15 minutes).
Number of Participants Who Experienced a Recurrent Seizure After Treatment.	2 participants	3 participants

Adverse Events

Phenytoin/Fosphenytoin

Serious events: 0 serious events

Other events: 40 other events

Deaths: 0 deaths

Levetiracetam

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Phenytoin/Fosphenytoin n=82 participants at risk Patients in the control arm will receive either IV Dilantin (1 gram of IV phenytoin infused at 25 mg/min or slower depending on vitals) or IV Fosphenytoin (1 gram of IV Fosphenytoin infused at 15 mg/min or slower depending on vitals).	Levetiracetam n=76 participants at risk Patients in the intervention arm will receive IV Keppra (1 gram of Keppra added to 100 mL diluent infused over 15 minutes).
Investigations Fatigue	4.9% 4/82 • Number of events 4	9.2% 7/76 • Number of events 7
Investigations Burning at the IV Site	13.4% 11/82 • Number of events 15	6.6% 5/76 • Number of events 5
Investigations Itching	9.8% 8/82 • Number of events 8	0.00% 0/76
Investigations Dizziness	20.7% 17/82 • Number of events 17	9.2% 7/76 • Number of events 7

Additional Information

Brittney Copeland

Emory

Phone: 404-616-0301

Email: bcopel3@emory.edu

Results disclosure agreements

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