Trial Outcomes & Findings for Open-label Study of Levetiracetam Intravenous Infusion in Children (1 Month-4 Years Old) With Epilepsy (NCT NCT00505934)
NCT ID: NCT00505934
Last Updated: 2015-07-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
Treatment period (up to 4 days)
Results posted on
2015-07-15
Participant Flow
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.
Participant Flow refers to the Intent-to-treat (ITT) Population, consisting of all subjects who received at least 1 dose of study medication.
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 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 Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
3
|
|
Overall Study
STARTED
|
19
|
Reasons for withdrawal
| 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 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 Study
Adverse Event
|
1
|
|
Overall Study
Other: Unable to obtain IV & PK samples
|
1
|
|
Overall Study
Other: IV dose needed to be changed
|
1
|
Baseline Characteristics
Open-label Study of Levetiracetam Intravenous Infusion in Children (1 Month-4 Years Old) With Epilepsy
Baseline characteristics by cohort
| Measure |
Levetiracetam
n=19 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 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).
|
|---|---|
|
Age, Categorical
<=18 years
|
19 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
|
1.59 years
STANDARD_DEVIATION 1.24 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Treatment period (up to 4 days)Population: All 19 subjects enrolled in the study were included in the Intent to Treat (ITT) population and are included in this analysis.
Outcome measures
| Measure |
Levetiracetam
n=19 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 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).
|
|---|---|
|
Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 4 Days)
|
12 Subjects
|
SECONDARY outcome
Timeframe: Treatment period (up to 4 days)Population: All 19 subjects enrolled in the study were included in the Intent to Treat (ITT) population and are included in this analysis.
Outcome measures
| Measure |
Levetiracetam
n=19 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 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).
|
|---|---|
|
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)
|
6 Subjects
|
SECONDARY outcome
Timeframe: Treatment period (up to 4 days)Population: All 19 subjects enrolled in the study were included in the Intent to Treat (ITT) population and are included in this analysis.
Outcome measures
| Measure |
Levetiracetam
n=19 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 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).
|
|---|---|
|
Number of Consecutive Levetiracetam Intravenous (LEV IV) Doses Received
|
2.89 Consecutive doses
Standard Deviation 1.41
|
Adverse Events
Levetiracetam
Serious events: 4 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Levetiracetam
n=19 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 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).
|
|---|---|
|
Cardiac disorders
BRADYCARDIA
|
5.3%
1/19 • Number of events 1 • Up to 4 days
|
|
Cardiac disorders
CARDIAC ARREST
|
5.3%
1/19 • Number of events 1 • Up to 4 days
|
|
General disorders
PYREXIA
|
5.3%
1/19 • Number of events 1 • Up to 4 days
|
|
Infections and infestations
PNEUMONIA
|
10.5%
2/19 • Number of events 3 • Up to 4 days
|
|
Infections and infestations
ABDOMINAL SEPSIS
|
5.3%
1/19 • Number of events 1 • Up to 4 days
|
|
Investigations
ELECTROCARDIOGRAM QT PROLONGED
|
5.3%
1/19 • Number of events 1 • Up to 4 days
|
|
Metabolism and nutrition disorders
METABOLIC ACIDOSIS
|
10.5%
2/19 • Number of events 2 • Up to 4 days
|
|
Nervous system disorders
CONVULSION
|
5.3%
1/19 • Number of events 1 • Up to 4 days
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
5.3%
1/19 • Number of events 1 • Up to 4 days
|
Other adverse events
| Measure |
Levetiracetam
n=19 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 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).
|
|---|---|
|
Cardiac disorders
BRADYCARDIA
|
5.3%
1/19 • Number of events 1 • Up to 4 days
|
|
Eye disorders
EYE SWELLING
|
5.3%
1/19 • Number of events 1 • Up to 4 days
|
|
Gastrointestinal disorders
VOMITING
|
5.3%
1/19 • Number of events 1 • Up to 4 days
|
|
General disorders
PYREXIA
|
10.5%
2/19 • Number of events 2 • Up to 4 days
|
|
General disorders
IRRITABILITY
|
5.3%
1/19 • Number of events 1 • Up to 4 days
|
|
General disorders
PAIN
|
5.3%
1/19 • Number of events 1 • Up to 4 days
|
|
General disorders
PUNCTURE SITE PAIN
|
5.3%
1/19 • Number of events 1 • Up to 4 days
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
5.3%
1/19 • Number of events 1 • Up to 4 days
|
|
Investigations
ELECTROENCEPHALOGRAM
|
5.3%
1/19 • Number of events 1 • Up to 4 days
|
|
Nervous system disorders
SOMNOLENCE
|
5.3%
1/19 • Number of events 3 • Up to 4 days
|
|
Nervous system disorders
DROOLING
|
5.3%
1/19 • Number of events 1 • Up to 4 days
|
|
Nervous system disorders
MYOCLONIC EPILEPSY
|
5.3%
1/19 • Number of events 1 • Up to 4 days
|
|
Psychiatric disorders
RESTLESSNESS
|
5.3%
1/19 • Number of events 1 • Up to 4 days
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
5.3%
1/19 • Number of events 1 • Up to 4 days
|
|
Skin and subcutaneous tissue disorders
PETECHIAE
|
5.3%
1/19 • Number of events 1 • Up to 4 days
|
|
Skin and subcutaneous tissue disorders
NEURODERMATITIS
|
5.3%
1/19 • Number of events 1 • Up to 4 days
|
|
Vascular disorders
HYPOTENSION
|
10.5%
2/19 • Number of events 2 • 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