Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00535392
Recruitment Status : Completed
First Posted : September 26, 2007
Results First Posted : February 25, 2011
Last Update Posted : August 31, 2011
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Epilepsy
Intervention Drug: Levetiracetam
Enrollment 33
Recruitment Details 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  
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.

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).

Period Title: Overall Study
Started 33
Completed 33
Not Completed 0
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.

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).

Overall Number of Baseline Participants 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
<=18 years
33
 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 33 participants
9.71  (3.38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
Female
14
  42.4%
Male
19
  57.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 33 participants
France 4
United States 7
Mexico 10
Belgium 5
Turkey 6
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 33 subjects enrolled in the study were 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.

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).

Overall Number of Participants Analyzed 33
Measure Type: Number
Unit of Measure: Subjects
21
2.Secondary Outcome
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)
Hide Description [Not Specified]
Time Frame Treatment period (up to 4 days)
Hide Outcome Measure Data
Hide Analysis Population Description
All 33 subjects enrolled in the study were 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.

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).

Overall Number of Participants Analyzed 33
Measure Type: Number
Unit of Measure: Subjects
10
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 33 subjects enrolled in the study were 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.

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).

Overall Number of Participants Analyzed 33
Mean (Standard Deviation)
Unit of Measure: Consecutive doses
3.73  (1.61)
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.

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).

All-Cause Mortality
Levetiracetam
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Levetiracetam
Affected / at Risk (%) # Events
Total   3/33 (9.09%)    
Gastrointestinal disorders   
VOMITING * 1  1/33 (3.03%)  1
General disorders   
PYREXIA * 1  1/33 (3.03%)  1
Nervous system disorders   
CONVULSION * 1  1/33 (3.03%)  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   12/33 (36.36%)    
Gastrointestinal disorders   
NAUSEA * 1  3/33 (9.09%)  3
DRY MOUTH * 1  3/33 (9.09%)  3
VOMITING * 1  2/33 (6.06%)  3
General disorders   
PYREXIA * 1  2/33 (6.06%)  3
Investigations   
WEIGHT DECREASED * 1  2/33 (6.06%)  2
Nervous system disorders   
CONVULSION * 1  3/33 (9.09%)  5
SOMNOLENCE * 1  2/33 (6.06%)  7
Vascular disorders   
HYPOTENSION * 1  3/33 (9.09%)  4
*
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
ClinicalTrials.gov Identifier: NCT00535392     History of Changes
Other Study ID Numbers: N01274
2006-005722-23 ( EudraCT Number )
First Submitted: September 25, 2007
First Posted: September 26, 2007
Results First Submitted: January 28, 2011
Results First Posted: February 25, 2011
Last Update Posted: August 31, 2011