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

• ClinicalTrials.gov Identifier: NCT00510783
• Recruitment Status: Completed
• First Posted: August 2, 2007
• Results First Posted: August 5, 2013
• Last Update Posted: December 12, 2013
• Sponsor: Emory University
• Collaborator: UCB Pharma
• Information provided by (Responsible Party): Debra Houry, MD, MPH, Emory University

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Tonic-clonic Seizure
• Interventions: Drug: Keppra; Drug: Fosphenytoin; Drug: Dilantin
• Enrollment: 158

Participant Flow

Recruitment Details	Study completed
Pre-assignment Details	study completed

Arm/Group Title	Phenytoin/Fosphenytoin	Levetiracetam
Arm/Group Description	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).	Patients in the intervention arm will receive IV Keppra (1 gram of Keppra added to 100 mL diluent infused over 15 minutes).
Period Title: Overall Study
Started	82	76
Completed	51	47
Not Completed	31	29
Reason Not Completed
Lost to Follow-up	29	25
Withdrawal by Subject	2	3
Protocol Violation	0	1

Baseline Characteristics

Arm/Group Title		Phenytoin/Fosphenytoin	Levetiracetam	Total
Arm/Group Description		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).	Patients in the intervention arm will receive IV Keppra (1 gram of Keppra added to 100 mL diluent infused over 15 minutes).	Total of all reporting groups
Overall Number of Baseline Participants		82	76	158
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	82 participants	76 participants	158 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	80 97.6%	73 96.1%	153 96.8%
	>=65 years	2 2.4%	3 3.9%	5 3.2%
Age Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	82 participants	76 participants	158 participants
		51.80 (106.459)	65.79 (154.721)	58.53 (131.651)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	82 participants	76 participants	158 participants
	Female	56 68.3%	53 69.7%	109 69.0%
	Male	26 31.7%	23 30.3%	49 31.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	82 participants	76 participants	158 participants
		82	76	158

Outcome Measures

1. Primary Outcome

Title	Number of Participants Who Experienced a Recurrent Seizure After Treatment.
Description	Recurrent seizure is defined as a seizure within 24 hours of treatment in the Emergency Department.
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenytoin/Fosphenytoin	Levetiracetam
Arm/Group Description:	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).	Patients in the intervention arm will receive IV Keppra (1 gram of Keppra added to 100 mL diluent infused over 15 minutes).
Overall Number of Participants Analyzed	82	76
Measure Type: Number; Unit of Measure: participants
	2	3

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Phenytoin/Fosphenytoin		Levetiracetam
Arm/Group Description	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).		Patients in the intervention arm will receive IV Keppra (1 gram of Keppra added to 100 mL diluent infused over 15 minutes).
All-Cause Mortality
	Phenytoin/Fosphenytoin		Levetiracetam
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events
	Phenytoin/Fosphenytoin		Levetiracetam
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/82 (0.00%)		0/76 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Phenytoin/Fosphenytoin		Levetiracetam
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	40/82 (48.78%)		19/76 (25.00%)
Investigations
Fatigue †	4/82 (4.88%)	4	7/76 (9.21%)	7
Burning at the IV Site †	11/82 (13.41%)	15	5/76 (6.58%)	5
Itching †	8/82 (9.76%)	8	0/76 (0.00%)	0
Dizziness †	17/82 (20.73%)	17	7/76 (9.21%)	7
† Indicates events were collected by systematic assessment

Limitations and Caveats

Several patients were lost to follow-up.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Brittney Copeland
• Organization: Emory
• Phone: 404-616-0301
• EMail: bcopel3@emory.edu

• Responsible Party: Debra Houry, MD, MPH, Emory University
• ClinicalTrials.gov Identifier: NCT00510783 History of Changes
• Obsolete Identifiers: NCT00832858
• Other Study ID Numbers: IRB00002266
• First Submitted: July 31, 2007
• First Posted: August 2, 2007
• Results First Submitted: January 8, 2011
• Results First Posted: August 5, 2013
• Last Update Posted: December 12, 2013