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Open-label Study of Levetiracetam Intravenous Infusion in Children (1 Month-4 Years Old) With Epilepsy

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ClinicalTrials.gov Identifier: NCT00505934
Recruitment Status : Completed
First Posted : July 25, 2007
Results First Posted : February 25, 2011
Last Update Posted : July 15, 2015
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Pharma SA )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Epilepsy
Intervention Drug: Levetiracetam
Enrollment 19
Recruitment Details Subjects were recruited from sites in the United States, Belgium, Germany, France, Mexico, and Turkey. The study began in May 2008 and continued until March 2010, with the last subject's visit occurring in March of 2010.
Pre-assignment Details Participant Flow refers to the Intent-to-treat (ITT) Population, consisting of all subjects who received at least 1 dose of study medication.
Arm/Group Title Levetiracetam
Hide Arm/Group Description

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 within the following dose range, calculated on the basis of their age and weight:.

  • Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily);
  • Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily).

For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows:

  • Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily).
  • Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily).
Period Title: Overall Study
Started 19 [1]
Completed 16
Not Completed 3
Reason Not Completed
Adverse Event             1
Other: Unable to obtain IV & PK samples             1
Other: IV dose needed to be changed             1
[1]
Of the 23 subjects screened, 19 were enrolled into the study and received levetiracetam IV (LEV IV).
Arm/Group Title Levetiracetam
Hide Arm/Group Description

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 within the following dose range, calculated on the basis of their age and weight:.

  • Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily);
  • Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily).

For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows:

  • Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily).
  • Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily).
Overall Number of Baseline Participants 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
<=18 years
19
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants
1.59  (1.24)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
7
  36.8%
Male
12
  63.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants
United States 7
Mexico 8
Belgium 1
Turkey 2
Germany 1
1.Primary Outcome
Title Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 4 Days)
Hide Description [Not Specified]
Time Frame Treatment period (up to 4 days)
Hide Outcome Measure Data
Hide Analysis Population Description
All 19 subjects enrolled in the study were included in the Intent to Treat (ITT) population and are included in this analysis.
Arm/Group Title Levetiracetam
Hide Arm/Group Description:

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 within the following dose range, calculated on the basis of their age and weight:.

  • Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily);
  • Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily).

For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows:

  • Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily).
  • Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily).
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: Subjects
12
2.Secondary Outcome
Title Number of Subjects Who Received High-dose Levetiracetam Intravenous (LEV IV) (More Than 28 mg/kg/Day for Subjects <6 Months; >40mg/kg/Day for Subjects ≥6 Months) During the Treatment Period (up to 4 Days)
Hide Description [Not Specified]
Time Frame Treatment period (up to 4 days)
Hide Outcome Measure Data
Hide Analysis Population Description
All 19 subjects enrolled in the study were included in the Intent to Treat (ITT) population and are included in this analysis.
Arm/Group Title Levetiracetam
Hide Arm/Group Description:

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 within the following dose range, calculated on the basis of their age and weight:.

  • Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily);
  • Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily).

For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows:

  • Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily).
  • Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily).
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: Subjects
6
3.Secondary Outcome
Title Number of Consecutive Levetiracetam Intravenous (LEV IV) Doses Received
Hide Description [Not Specified]
Time Frame Treatment period (up to 4 days)
Hide Outcome Measure Data
Hide Analysis Population Description
All 19 subjects enrolled in the study were included in the Intent to Treat (ITT) population and are included in this analysis.
Arm/Group Title Levetiracetam
Hide Arm/Group Description:

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 within the following dose range, calculated on the basis of their age and weight:.

  • Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily);
  • Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily).

For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows:

  • Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily).
  • Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily).
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: Consecutive doses
2.89  (1.41)
Time Frame Up to 4 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Levetiracetam
Hide Arm/Group Description

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 within the following dose range, calculated on the basis of their age and weight:.

  • Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily);
  • Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily).

For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows:

  • Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily).
  • Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily).
All-Cause Mortality
Levetiracetam
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Levetiracetam
Affected / at Risk (%) # Events
Total   4/19 (21.05%)    
Cardiac disorders   
BRADYCARDIA * 1  1/19 (5.26%)  1
CARDIAC ARREST * 1  1/19 (5.26%)  1
General disorders   
PYREXIA * 1  1/19 (5.26%)  1
Infections and infestations   
PNEUMONIA * 1  2/19 (10.53%)  3
ABDOMINAL SEPSIS * 1  1/19 (5.26%)  1
Investigations   
ELECTROCARDIOGRAM QT PROLONGED * 1  1/19 (5.26%)  1
Metabolism and nutrition disorders   
METABOLIC ACIDOSIS * 1  2/19 (10.53%)  2
Nervous system disorders   
CONVULSION * 1  1/19 (5.26%)  1
Respiratory, thoracic and mediastinal disorders   
RESPIRATORY FAILURE * 1  1/19 (5.26%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Levetiracetam
Affected / at Risk (%) # Events
Total   10/19 (52.63%)    
Cardiac disorders   
BRADYCARDIA * 1  1/19 (5.26%)  1
Eye disorders   
EYE SWELLING * 1  1/19 (5.26%)  1
Gastrointestinal disorders   
VOMITING * 1  1/19 (5.26%)  1
General disorders   
PYREXIA * 1  2/19 (10.53%)  2
IRRITABILITY * 1  1/19 (5.26%)  1
PAIN * 1  1/19 (5.26%)  1
PUNCTURE SITE PAIN * 1  1/19 (5.26%)  1
Injury, poisoning and procedural complications   
PROCEDURAL PAIN * 1  1/19 (5.26%)  1
Investigations   
ELECTROENCEPHALOGRAM * 1  1/19 (5.26%)  1
Nervous system disorders   
SOMNOLENCE * 1  1/19 (5.26%)  3
DROOLING * 1  1/19 (5.26%)  1
MYOCLONIC EPILEPSY * 1  1/19 (5.26%)  1
Psychiatric disorders   
RESTLESSNESS * 1  1/19 (5.26%)  1
Respiratory, thoracic and mediastinal disorders   
RHINORRHOEA * 1  1/19 (5.26%)  1
Skin and subcutaneous tissue disorders   
PETECHIAE * 1  1/19 (5.26%)  1
NEURODERMATITIS * 1  1/19 (5.26%)  1
Vascular disorders   
HYPOTENSION * 1  2/19 (10.53%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.0)
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.
UCB has > 60 days but <= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB Clinical Trial Call Center
Organization: UCB
Phone: +1 877 822 9493
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB Pharma SA )
ClinicalTrials.gov Identifier: NCT00505934     History of Changes
Other Study ID Numbers: N01275
2007-003517-13 ( EudraCT Number )
First Submitted: July 20, 2007
First Posted: July 25, 2007
Results First Submitted: January 28, 2011
Results First Posted: February 25, 2011
Last Update Posted: July 15, 2015