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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Levetiracetam This group will receive treatment with Levetiracetam.
Phenytoin This group will receive treatment with Phenytoin.

Participant Flow:   Overall Study
    Levetiracetam   Phenytoin
STARTED   34   18 
COMPLETED   34   18 
NOT COMPLETED   0   0 



  Baseline Characteristics

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.
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.

Reporting Groups
  Description
Levetiracetam This group will receive treatment with Levetiracetam.
Phenytoin This group will receive treatment with Phenytoin.
Total Total of all reporting groups

Baseline Measures
   Levetiracetam   Phenytoin   Total 
Overall Participants Analyzed 
[Units: Participants]
 34   18   52 
Age 
[Units: Years]
Median (Full Range)
 44 
 (17 to 75) 
 35 
 (18 to 80) 
 42.5 
 (17 to 80) 
Gender 
[Units: Participants]
     
Female   8   5   13 
Male   26   13   39 
Region of Enrollment 
[Units: Participants]
     
United States   34   18   52 


  Outcome Measures

1.  Primary:   Seizure Incidence   [ Time Frame: Duration of study, up to 6 months after the injury ]

2.  Secondary:   Extended Glasgow Outcome Score   [ Time Frame: at discharge; 3 and 6 months following injury ]

3.  Secondary:   Disability Rating Scale (DRS)   [ Time Frame: Discharge; 3 and 6 months following injury ]

4.  Secondary:   Incidence of Adverse Events   [ Time Frame: discharge; 3 and 6 months following injury ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  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: Dr. Lori Shutter
Organization: University of Pittsburgh
phone: 1-412-647-8410
e-mail: shutterla@upmc.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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