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

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

  Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study completed

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
study completed

Reporting Groups

	Description
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).

Participant Flow:   Overall Study

	Phenytoin/Fosphenytoin	Levetiracetam
STARTED	82	76
COMPLETED	51	47
NOT COMPLETED	31	29
Lost to Follow-up	29	25
Withdrawal by Subject	2	3
Protocol Violation	0	1

  Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
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).
Total	Total of all reporting groups

Baseline Measures

	Phenytoin/Fosphenytoin	Levetiracetam	Total
Overall Participants Analyzed; [Units: Participants]	82	76	158
Age; [Units: Participants]
<=18 years	0	0	0
Between 18 and 65 years	80	73	153
>=65 years	2	3	5
Age; [Units: Years]; Mean (Standard Deviation)	51.80 (106.459)	65.79 (154.721)	58.53 (131.651)
Gender; [Units: Participants]
Female	56	53	109
Male	26	23	49
Region of Enrollment; [Units: Participants]
United States	82	76	158

  Outcome Measures

1. Primary:

Number of Participants Who Experienced a Recurrent Seizure After Treatment. [ Time Frame: 24 hours ]

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  Serious Adverse Events

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  Other Adverse Events

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  Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Several patients were lost to follow-up.

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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
e-mail: 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