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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
Enrollment 126
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Levetiracetam Observational
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 66 60
Completed 59 [1] 54 [2]
Not Completed 7 6
Reason Not Completed
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
Arm/Group Title Levetiracetam Observational Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 66 60 126
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 60 participants 126 participants
<=18 years
20
  30.3%
20
  33.3%
40
  31.7%
Between 18 and 65 years
41
  62.1%
33
  55.0%
74
  58.7%
>=65 years
5
   7.6%
7
  11.7%
12
   9.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 60 participants 126 participants
Female
16
  24.2%
11
  18.3%
27
  21.4%
Male
50
  75.8%
49
  81.7%
99
  78.6%
1.Primary Outcome
Title Post-Traumatic Epilepsy
Hide Description occurrence of PTE (Post-Traumatic Epilepsy)
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Levetiracetam Observational
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 66 60
Measure Type: Number
Unit of Measure: participants
6 8
2.Secondary Outcome
Title Adverse Events
Hide Description The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period.
Time Frame 30 day treatment period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Symptoms reported to be moderate or severe are listed. Adverse events were not monitored for the Observational group.
Arm/Group Title Participants
Hide Arm/Group Description:
The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. schedule were monitored for adverse events through the 30 day treatment period.
Overall Number of Participants Analyzed 66
Measure Type: Number
Unit of Measure: Events
Headache 28
Fatigue 28
Drowsiness 20
Memory Impairment 9
Amnesia 8
Pain 15
Irritability 10
Dizziness 10
Anorexia 6
Emotional lability 7
Insomnia 5
Cognitive changes 7
Ataxia 6
Depression 7
Hostility 3
Vertigo 1
Nausea 2
Cough 2
Nervousness 5
Paraesthesia 3
Weight gain 1
Hallucinations 5
Other 2
Diplopia 3
Suicidality 3
Psychosis 3
Time Frame 30 day treatment period
Adverse Event Reporting Description The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.
 
Arm/Group Title Levetiracetam Observational
Hide Arm/Group Description The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group. Adverse events were not monitored for the Observational group
All-Cause Mortality
Levetiracetam Observational
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Levetiracetam Observational
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/66 (27.27%)      0/0    
Psychiatric disorders     
Depression * 1  7/66 (10.61%)  7 0/0  0
Halluscinations * 1  5/66 (7.58%)  5 0/0  0
Suicidality * 1  3/66 (4.55%)  3 0/0  0
Psychosis * 1  3/66 (4.55%)  3 0/0  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Levetiracetam Observational
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   66/66 (100.00%)      0/0    
Ear and labyrinth disorders     
Vertigo * 1  1/66 (1.52%)  1 0/0  0
Gastrointestinal disorders     
Nausea * 1  2/66 (3.03%)  2 0/0  0
General disorders     
Fatigue * 1  28/66 (42.42%)  28 0/0  0
Pain * 1  15/66 (22.73%)  15 0/0  0
Irritability * 1  10/66 (15.15%)  10 0/0  0
Investigations     
Weight Gain * 1  1/66 (1.52%)  1 0/0  0
Metabolism and nutrition disorders     
Anorexia * 1  6/66 (9.09%)  6 0/0  0
Nervous system disorders     
Headache * 1  28/66 (42.42%)  28 0/0  0
Drowsiness * 1  20/66 (30.30%)  20 0/0  0
Memory Impairment * 1  9/66 (13.64%)  9 0/0  0
Amnesia * 1  8/66 (12.12%)  8 0/0  0
Dizziness * 1  10/66 (15.15%)  10 0/0  0
Cognitive disturbance * 1  7/66 (10.61%)  7 0/0  0
Ataxia * 1  6/66 (9.09%)  6 0/0  0
Psychiatric disorders     
Insomnia * 1  5/66 (7.58%)  5 0/0  0
Respiratory, thoracic and mediastinal disorders     
Cough * 1  2/66 (3.03%)  2 0/0  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE
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
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