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Open-label Study of Levetiracetam Intravenous Infusion in Children (4-16 Years Old) With Epilepsy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00535392
First received: September 25, 2007
Last updated: August 30, 2011
Last verified: March 2011
History of Changes
Results First Received: January 28, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Epilepsy
Intervention: Drug: Levetiracetam

  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
Subjects were recruited from sites in the United States, Belgium, Germany, France, Mexico, and Turkey. The study began in September 2007 and continued until February 2010, with the last subject's visit occurring in February of 2010.

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

Intravenous 100 mg/mL, twice a day, maximum of 4 days

Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose.

Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily).

Participant Flow:   Overall Study
    Levetiracetam  
STARTED     33  
COMPLETED     33  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
Levetiracetam

Intravenous 100 mg/mL, twice a day, maximum of 4 days

Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose.

Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily).

Baseline Measures
    Levetiracetam  
Number of Participants  
[units: participants]
 		  33  
Age  
[units: participants]
 		 
<=18 years     33  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation 		  9.71  ± 3.38  
Gender  
[units: participants]
 		 
Female     14  
Male     19  
Region of Enrollment  
[units: participants]
 		 
France     4  
United States     7  
Mexico     10  
Belgium     5  
Turkey     6  
Germany     1  



  Outcome Measures
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1.  Primary:   Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 4 Days)   [ Time Frame: Treatment period (up to 4 days) ]

Measure Type Primary
Measure Title Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 4 Days)
Measure Description No text entered.
Time Frame Treatment period (up to 4 days)  
Safety Issue No  

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.
All 33 subjects enrolled in the study were in the Intent to Treat (ITT) population and are included in this analysis.

Reporting Groups
  Description
Levetiracetam

Intravenous 100 mg/mL, twice a day, maximum of 4 days

Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose.

Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily).

Measured Values
    Levetiracetam  
Number of Participants Analyzed  
[units: participants]
 		  33  
Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 4 Days)  
[units: Subjects]
 		  21  

No statistical analysis provided for Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 4 Days)



2.  Secondary:   Number of Subjects Who Received High-dose Levetiracetam Intravenous (LEV IV) (More Than 40 mg/kg/Day) During the Treatment Period (up to 4 Days)   [ Time Frame: Treatment period (up to 4 days) ]

Measure Type Secondary
Measure Title Number of Subjects Who Received High-dose Levetiracetam Intravenous (LEV IV) (More Than 40 mg/kg/Day) During the Treatment Period (up to 4 Days)
Measure Description No text entered.
Time Frame Treatment period (up to 4 days)  
Safety Issue No  

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.
All 33 subjects enrolled in the study were in the Intent to Treat (ITT) population and are included in this analysis.

Reporting Groups
  Description
Levetiracetam

Intravenous 100 mg/mL, twice a day, maximum of 4 days

Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose.

Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily).

Measured Values
    Levetiracetam  
Number of Participants Analyzed  
[units: participants]
 		  33  
Number of Subjects Who Received High-dose Levetiracetam Intravenous (LEV IV) (More Than 40 mg/kg/Day) During the Treatment Period (up to 4 Days)  
[units: Subjects]
 		  10  

No statistical analysis provided for Number of Subjects Who Received High-dose Levetiracetam Intravenous (LEV IV) (More Than 40 mg/kg/Day) During the Treatment Period (up to 4 Days)



3.  Secondary:   Number of Consecutive Levetiracetam Intravenous (LEV IV) Doses Received   [ Time Frame: Treatment period (up to 4 days) ]

Measure Type Secondary
Measure Title Number of Consecutive Levetiracetam Intravenous (LEV IV) Doses Received
Measure Description No text entered.
Time Frame Treatment period (up to 4 days)  
Safety Issue No  

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.
All 33 subjects enrolled in the study were in the Intent to Treat (ITT) population and are included in this analysis.

Reporting Groups
  Description
Levetiracetam

Intravenous 100 mg/mL, twice a day, maximum of 4 days

Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose.

Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily).

Measured Values
    Levetiracetam  
Number of Participants Analyzed  
[units: participants]
 		  33  
Number of Consecutive Levetiracetam Intravenous (LEV IV) Doses Received  
[units: Consecutive  doses]
Mean ± Standard Deviation 		  3.73  ± 1.61  

No statistical analysis provided for Number of Consecutive Levetiracetam Intravenous (LEV IV) Doses Received




  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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.  


Results Point of Contact:  
Name/Title: UCB Clinical Trial Call Center
Organization: UCB
phone: +1 877 822 9493


No publications provided


Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00535392     History of Changes
Other Study ID Numbers: N01274, 2006-005722-23
Study First Received: September 25, 2007
Results First Received: January 28, 2011
Last Updated: August 30, 2011
Health Authority: United States: Food and Drug Administration
Belgium: Directorate general for the protection of Public health: Medicines
Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Mexico: Federal Commission for Protection Against Health Risks
Turkey: Ministry of Health