Trial Outcomes & Findings for Open-label Study of Levetiracetam Intravenous Infusion in Children (4-16 Years Old) With Epilepsy (NCT NCT00535392)
NCT ID: NCT00535392
Last Updated: 2011-08-31
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
Treatment period (up to 4 days)
Results posted on
2011-08-31
Participant Flow
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.
Participant milestones
| Measure |
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).
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Open-label Study of Levetiracetam Intravenous Infusion in Children (4-16 Years Old) With Epilepsy
Baseline characteristics by cohort
| Measure |
Levetiracetam
n=33 Participants
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).
|
|---|---|
|
Age, Categorical
<=18 years
|
33 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
9.71 years
STANDARD_DEVIATION 3.38 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
4 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Treatment period (up to 4 days)Population: All 33 subjects enrolled in the study were in the Intent to Treat (ITT) population and are included in this analysis.
Outcome measures
| Measure |
Levetiracetam
n=33 Participants
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).
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|---|---|
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Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 4 Days)
|
21 Subjects
|
SECONDARY outcome
Timeframe: Treatment period (up to 4 days)Population: All 33 subjects enrolled in the study were in the Intent to Treat (ITT) population and are included in this analysis.
Outcome measures
| Measure |
Levetiracetam
n=33 Participants
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).
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|---|---|
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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)
|
10 Subjects
|
SECONDARY outcome
Timeframe: Treatment period (up to 4 days)Population: All 33 subjects enrolled in the study were in the Intent to Treat (ITT) population and are included in this analysis.
Outcome measures
| Measure |
Levetiracetam
n=33 Participants
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).
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|---|---|
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Number of Consecutive Levetiracetam Intravenous (LEV IV) Doses Received
|
3.73 Consecutive doses
Standard Deviation 1.61
|
Adverse Events
Levetiracetam
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Levetiracetam
n=33 participants at risk
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).
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|---|---|
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Gastrointestinal disorders
VOMITING
|
3.0%
1/33 • Number of events 1 • Up to 4 days
|
|
General disorders
PYREXIA
|
3.0%
1/33 • Number of events 1 • Up to 4 days
|
|
Nervous system disorders
CONVULSION
|
3.0%
1/33 • Number of events 1 • Up to 4 days
|
Other adverse events
| Measure |
Levetiracetam
n=33 participants at risk
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).
|
|---|---|
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Gastrointestinal disorders
NAUSEA
|
9.1%
3/33 • Number of events 3 • Up to 4 days
|
|
Gastrointestinal disorders
DRY MOUTH
|
9.1%
3/33 • Number of events 3 • Up to 4 days
|
|
Gastrointestinal disorders
VOMITING
|
6.1%
2/33 • Number of events 3 • Up to 4 days
|
|
General disorders
PYREXIA
|
6.1%
2/33 • Number of events 3 • Up to 4 days
|
|
Investigations
WEIGHT DECREASED
|
6.1%
2/33 • Number of events 2 • Up to 4 days
|
|
Nervous system disorders
CONVULSION
|
9.1%
3/33 • Number of events 5 • Up to 4 days
|
|
Nervous system disorders
SOMNOLENCE
|
6.1%
2/33 • Number of events 7 • Up to 4 days
|
|
Vascular disorders
HYPOTENSION
|
9.1%
3/33 • Number of events 4 • Up to 4 days
|
Additional Information
UCB Clinical Trial Call Center
UCB
Phone: +1 877 822 9493
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER