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Trial record 20 of 1741 for:    Epilepsy

Levetiracetam to Prevent Post-Traumatic Epilepsy

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ClinicalTrials.gov Identifier: NCT01463033
Recruitment Status : Completed
First Posted : November 1, 2011
Results First Posted : November 2, 2015
Last Update Posted : January 13, 2016
Sponsor:
Collaborator:
Medstar Health Research Institute
Information provided by (Responsible Party):
Pavel Klein, Children's Research Institute

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: Epilepsy
Post-traumatic Epilepsy
Intervention: Drug: Levetiracetam

  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 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy will receive levetiracetam 55 mg/kg/day in a b.i.d. schedule. Treatment will commence within 8 hours of the acute head injury and will last for 30 days. In addition, subjects will receive phenytoin for 1 week following head injury as standard clinical care.
Observational 60 subjects with acute head injury with a high risk for developing post-traumatic epilepsy enrolled 8-24 hours after injury will not receive levetiracetam. Subjects will receive phenytoin for 1 week following head injury as standard clinical care.

Participant Flow:   Overall Study
    Levetiracetam   Observational
STARTED   66   60 
COMPLETED   59 [1]   54 [2] 
NOT COMPLETED   7   6 
Lost to Follow-up                4                4 
Death                3                2 
[1] 3 deaths, 4 lost to follow up
[2] 2 deaths, 4 lost to follow up



  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.
No text entered.

Reporting Groups
  Description
Levetiracetam 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy will receive levetiracetam 55 mg/kg/day in a b.i.d. schedule. Treatment will commence within 8 hours of the acute head injury and will last for 30 days. In addition, subjects will receive phenytoin for 1 week following head injury as standard clinical care.
Observational 60 subjects with acute head injury with a high risk for developing post-traumatic epilepsy enrolled 8-24 hours after injury will not receive levetiracetam. Subjects will receive phenytoin for 1 week following head injury as standard clinical care.
Total Total of all reporting groups

Baseline Measures
   Levetiracetam   Observational   Total 
Overall Participants Analyzed 
[Units: Participants]
 66   60   126 
Age 
[Units: Participants]
     
<=18 years   20   20   40 
Between 18 and 65 years   41   33   74 
>=65 years   5   7   12 
Gender 
[Units: Participants]
     
Female   16   11   27 
Male   50   49   99 


  Outcome Measures

1.  Primary:   Post-Traumatic Epilepsy   [ Time Frame: 2 years ]

2.  Secondary:   Adverse Events   [ Time Frame: 30 day treatment period ]


  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. Pavel Klein, P.I.
Organization: Children's National Medical Center
phone: 301-704-4925
e-mail: kleinp@epilepsydc.com


Publications of Results:

Responsible Party: Pavel Klein, Children's Research Institute
ClinicalTrials.gov Identifier: NCT01463033     History of Changes
Other Study ID Numbers: NS45656
First Submitted: October 12, 2011
First Posted: November 1, 2011
Results First Submitted: November 11, 2014
Results First Posted: November 2, 2015
Last Update Posted: January 13, 2016