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

• 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: UCB Pharma
• Information provided by (Responsible Party): UCB Pharma

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Epilepsy
• Intervention: Drug: Levetiracetam
• Enrollment: 33

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		Levetiracetam
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
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

Outcome Measures

1. Primary Outcome

Title	Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 4 Days)
Description	[Not Specified]
Time Frame	Treatment period (up to 4 days)

Outcome Measure Data

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
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)
Description	[Not Specified]
Time Frame	Treatment period (up to 4 days)

Outcome Measure Data

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
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
Description	[Not Specified]
Time Frame	Treatment period (up to 4 days)

Outcome Measure Data

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
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)

Adverse Events

Time Frame	Up to 4 days
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Levetiracetam
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	--/--
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)
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)

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: UCB Clinical Trial Call Center
• Organization: UCB
• Phone: +1 877 822 9493

• Responsible Party: UCB Pharma
• ClinicalTrials.gov Identifier: NCT00535392
• 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