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Assess Safety and Efficacy of Levetiracetam(LEV;Keppra)for Seizure Prevention (Keppra)

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ClinicalTrials.gov Identifier: NCT00618436
Recruitment Status : Completed
First Posted : February 20, 2008
Results First Posted : April 7, 2014
Last Update Posted : April 7, 2014
Sponsor:
Collaborator:
Mayfield Clinic & Spine Institute
Information provided by (Responsible Party):
Lori Shutter, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Traumatic Brain Injury
Subarachnoid Hemorrhage
Interventions Drug: Levetiracetam
Drug: Phenytoin
Enrollment 52

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Levetiracetam Phenytoin
Hide Arm/Group Description This group will receive treatment with Levetiracetam. This group will receive treatment with Phenytoin.
Period Title: Overall Study
Started 34 18
Completed 34 18
Not Completed 0 0
Arm/Group Title Levetiracetam Phenytoin Total
Hide Arm/Group Description This group will receive treatment with Levetiracetam. This group will receive treatment with Phenytoin. Total of all reporting groups
Overall Number of Baseline Participants 34 18 52
Hide Baseline Analysis Population Description
One patient was enrolled at 17 years of age. His age was unknown at the time of admission to the hospital after his trauma, and based on body size/habitus he appeared to be a young adult. It was later discovered that he was only 17, but turning 18 in 3 days. The PI decided to allow his participation in the study at the parents request.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 34 participants 18 participants 52 participants
44
(17 to 75)
35
(18 to 80)
42.5
(17 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 18 participants 52 participants
Female
8
  23.5%
5
  27.8%
13
  25.0%
Male
26
  76.5%
13
  72.2%
39
  75.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 34 participants 18 participants 52 participants
34 18 52
1.Primary Outcome
Title Seizure Incidence
Hide Description This was the number of patients in each group who demonstrated seizure activity during the course of the study
Time Frame Duration of study, up to 6 months after the injury
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Levetiracetam Phenytoin
Hide Arm/Group Description:
This group will receive treatment with Levetiracetam.
This group will receive treatment with Phenytoin.
Overall Number of Participants Analyzed 34 18
Measure Type: Number
Unit of Measure: Participants
5 3
2.Secondary Outcome
Title Extended Glasgow Outcome Score
Hide Description This is an 8 point validated scale that measures disability after brain injury. It is assessed through an in person exam or by phone interview at hospital discharge, 3 months and 6 months after injury. The categories are: 1 = dead; 2 = vegetative state; 3 = severe disability, low level; 4 = severe disability, high level; 5 = moderate disability, low level; 6 = moderate disability, high level; 7 = good recovery - low level; 8 = good recovery - high level. Specific questions and activities are assessed to determine into which category the patient falls.
Time Frame at discharge; 3 and 6 months following injury
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients
Arm/Group Title Levetiracetam Phenytoin
Hide Arm/Group Description:
This group will receive treatment with Levetiracetam.
This group will receive treatment with Phenytoin.
Overall Number of Participants Analyzed 34 18
Mean (Full Range)
Unit of Measure: units on a scale
At Discharge
2
(1 to 4)
2
(1 to 3)
At 3 months
3
(1 to 7)
3
(1 to 5)
At 6 months
3
(1 to 8)
3
(1 to 7)
3.Secondary Outcome
Title Disability Rating Scale (DRS)
Hide Description The Disability rating scale (DRS) is frequently used in the rehabilitation literature as a measure of disability. It is a reliable, easily performed test that assesses 8 items (eye opening, verbalization, motor response, feeding, toileting, grooming, level of functioning, employability), and assigns each a numerical score ranging from 0 - 5 based on the category. The domains these 8 items are felt to assess include: alertness, cognition for self-care, dependence, and psychosocial adaptability. The scoring range is from 0-30, with increasing disability levels assigned to higher numerical values. The total DRS is then dichotomized into favorable (disability = none, mild, partial or moderate disability) and unfavorable (disability = moderately severe, severe, extremely severe, vegetative state, extreme vegetative state, death) outcomes. A DRS score of 0-6 was favorable, with any score greater than 6 categorized as unfavorable.
Time Frame Discharge; 3 and 6 months following injury
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients
Arm/Group Title Levetiracetam Phenytoin
Hide Arm/Group Description:
This group will receive treatment with Levetiracetam.
This group will receive treatment with Phenytoin.
Overall Number of Participants Analyzed 34 18
Mean (Full Range)
Unit of Measure: units on a scale
At Discharge
24
(7 to 30)
23
(7 to 30)
At 3 months
15
(0 to 30)
13
(5 to 30)
At 6 months
17
(0 to 30)
9
(0 to 30)
4.Secondary Outcome
Title Incidence of Adverse Events
Hide Description [Not Specified]
Time Frame discharge; 3 and 6 months following injury
Outcome Measure Data Not Reported
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Levetiracetam Phenytoin
Hide Arm/Group Description This group will receive treatment with Levetiracetam. This group will receive treatment with Phenytoin.
All-Cause Mortality
Levetiracetam Phenytoin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Levetiracetam Phenytoin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/18 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Levetiracetam Phenytoin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/18 (0.00%) 
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: Dr. Lori Shutter
Organization: University of Pittsburgh
Phone: 1-412-647-8410
Responsible Party: Lori Shutter, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00618436     History of Changes
Other Study ID Numbers: 06-4-6-7
First Submitted: February 8, 2008
First Posted: February 20, 2008
Results First Submitted: August 29, 2013
Results First Posted: April 7, 2014
Last Update Posted: April 7, 2014