Trial Outcomes & Findings for Long-Term, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures (NCT NCT00152516)
NCT ID: NCT00152516
Last Updated: 2013-02-12
Results Overview
Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.
COMPLETED
PHASE3
255 participants
Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
2013-02-12
Participant Flow
102 sites in 17 countries participated in the study, of which 85 sites in 16 countries enrolled subjects in the study. First subject enrolled: 23 October 2004, Last subject last visit: 24 June 2008
Protocol amendment C2 (August 7, 2006) allowed direct enrollment from India, Australia, and New Zealand bypassing the blinded feeder studies N01009 and N01103.
Participant milestones
| Measure |
Levetiracetam
Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
|
|---|---|
|
Overall Study
STARTED
|
255
|
|
Overall Study
COMPLETED
|
180
|
|
Overall Study
NOT COMPLETED
|
75
|
Reasons for withdrawal
| Measure |
Levetiracetam
Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
|
|---|---|
|
Overall Study
Adverse Event
|
18
|
|
Overall Study
Lack and Loss of Efficacy
|
30
|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Withdrawal by Subject
|
8
|
|
Overall Study
Protocol Violation
|
3
|
|
Overall Study
Other: Mother Refused To Cooperate
|
1
|
|
Overall Study
Other: Given Commercial Drug in Error
|
2
|
|
Overall Study
Other: Parents Withdrew Consent
|
2
|
|
Overall Study
Other: Non-Compliance
|
2
|
|
Overall Study
Other: Primary Care Physician's Decision
|
1
|
|
Overall Study
Other: Moved Out Of State
|
1
|
|
Overall Study
Other: Underwent Surgery for Epilepsy
|
1
|
|
Overall Study
Other: Sz Worsening, Seeking 2nd Opinion
|
1
|
Baseline Characteristics
Long-Term, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures
Baseline characteristics by cohort
| Measure |
Levetiracetam
n=255 Participants
Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
|
|---|---|
|
Age, Categorical
<=18 years
|
255 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
|
5.28 years
STANDARD_DEVIATION 4.69 • n=5 Participants
|
|
Sex: Female, Male
Female
|
116 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
139 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
123 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
6 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
2 participants
n=5 Participants
|
|
Region of Enrollment
India
|
20 participants
n=5 Participants
|
|
Region of Enrollment
France
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
29 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
7 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)Population: 255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 4 were missing a baseline, 3 had a baseline of 0, and 1 was missing treatment period seizure data. The result was a sample size of 247. Of these 247 subjects 226 continued into the maintenance period.
Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.
Outcome measures
| Measure |
Levetiracetam
n=247 Participants
Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
|
|---|---|
|
Percentage Change (Reduction) of Partial (Type I) Seizure Frequency Per Week From Baseline Over Time During Treatment Period.
Up-titration/Conversion
|
51.06 percent reduction in seizures Per Week
Interval -10.7 to 91.59
|
|
Percentage Change (Reduction) of Partial (Type I) Seizure Frequency Per Week From Baseline Over Time During Treatment Period.
Maintenance
|
68.87 percent reduction in seizures Per Week
Interval -3.6 to 96.61
|
SECONDARY outcome
Timeframe: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)Population: 255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 4 were missing a baseline, 2 had a baseline of 0, and 1 was missing treatment period seizure data. The result was a sample size of 248. Of these 248 subjects 227 continued into the maintenance period.
Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.
Outcome measures
| Measure |
Levetiracetam
n=248 Participants
Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
|
|---|---|
|
Percentage Change (Reduction) of Total (Type I, II, III) Seizure Frequency Per Week From Baseline Over Time During Treatment Period.
Up-titration/Conversion Period
|
47.44 Percent Reduction in Seizures per Week
Interval -21.18 to 88.7
|
|
Percentage Change (Reduction) of Total (Type I, II, III) Seizure Frequency Per Week From Baseline Over Time During Treatment Period.
Maintenance Period
|
66.02 Percent Reduction in Seizures per Week
Interval -3.98 to 95.0
|
SECONDARY outcome
Timeframe: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)Population: 255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 1 was missing treatment period seizure data leaving a sample size of 254. Of these 254 subjects 233 continued into the maintenance period.
Outcome measures
| Measure |
Levetiracetam
n=254 Participants
Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
|
|---|---|
|
Partial (Type I) Seizure Frequency Per Week Over Time During Treatment Period.
Up-titration/Conversion Period
|
2.85 Seizures Per Week
Interval 0.23 to 26.3
|
|
Partial (Type I) Seizure Frequency Per Week Over Time During Treatment Period.
Maintenance Period
|
1.49 Seizures Per Week
Interval 0.07 to 17.89
|
SECONDARY outcome
Timeframe: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)Population: 255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 1 was missing treatment period seizure data leaving a sample size of 254. Of these 254 subjects 233 continued into the maintenance period.
Outcome measures
| Measure |
Levetiracetam
n=254 Participants
Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
|
|---|---|
|
Total (Type I, II, III) Seizure Frequency Per Week Over Time During Treatment Period.
Up-titration/Conversion Period
|
3.15 Seizures Per Week
Interval 0.25 to 31.17
|
|
Total (Type I, II, III) Seizure Frequency Per Week Over Time During Treatment Period.
Maintenance Period
|
1.91 Seizures Per Week
Interval 0.09 to 24.86
|
SECONDARY outcome
Timeframe: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)Population: 255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 4 were missing a baseline and 1 was missing treatment period seizure data. The result was a sample size of 250. Of these 250 subjects 229 continued into the maintenance period.
Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.
Outcome measures
| Measure |
Levetiracetam
n=250 Participants
Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
|
|---|---|
|
Change (Reduction) From Baseline in Partial (Type I) Seizure Frequency Per Week Over Time During Treatment Period
Up-titration/Conversion Period
|
0.72 Seizures Per Week
Interval -0.81 to 7.14
|
|
Change (Reduction) From Baseline in Partial (Type I) Seizure Frequency Per Week Over Time During Treatment Period
Maintenance Period
|
0.93 Seizures Per Week
Interval -0.33 to 8.99
|
SECONDARY outcome
Timeframe: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)Population: 255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 4 were missing a baseline and 1 was missing treatment period seizure data. The result was a sample size of 250. Of these 250 subjects 229 continued into the maintenance period.
Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.
Outcome measures
| Measure |
Levetiracetam
n=250 Participants
Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
|
|---|---|
|
Change (Reduction) From Baseline in Total (Type I, II, III) Seizure Frequency Per Week Over Time During Treatment Period
Up-titration/Conversion Period
|
0.69 Seizures Per Week
Interval -0.89 to 7.84
|
|
Change (Reduction) From Baseline in Total (Type I, II, III) Seizure Frequency Per Week Over Time During Treatment Period
Maintenance Period
|
0.93 Seizures Per Week
Interval -0.33 to 10.7
|
SECONDARY outcome
Timeframe: Up-titration (4 weeks); Maintenance Visits 3-4 (weeks 4-14, 6-15, or 8-16); Visits 4-5 (weeks 14-24, 15-24, or 16-24); Visits 5-6 (weeks 24-36); Visits 6-7 (weeks 36-48)Population: 255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 4 were missing a baseline, 3 had a baseline of 0, and 1 was missing treatment period seizure data. The result was a sample size of 247. Of these 247 subjects 226 continued into the maintenance period.
The responder rate is defined as the number of responders. A responder is a patient with a 50% or greater change (reduction) in partial seizure frequency per week. Note: Rates were reported as percentages.
Outcome measures
| Measure |
Levetiracetam
n=247 Participants
Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
|
|---|---|
|
Partial Seizure (Type I) Responder Rate (Percent) During the Up-titration/Conversion Phase and by Visit During the Maintenance Phase
Up-titration/Conversion (4 weeks)
|
50.6 Percentage of Participants
|
|
Partial Seizure (Type I) Responder Rate (Percent) During the Up-titration/Conversion Phase and by Visit During the Maintenance Phase
Maintenance Visits 3-4 (weeks 4-14, 6-15, or 8-16)
|
59.8 Percentage of Participants
|
|
Partial Seizure (Type I) Responder Rate (Percent) During the Up-titration/Conversion Phase and by Visit During the Maintenance Phase
Maint. Visits 4-5 (weeks 14-24, 15-24, or 16-24);
|
65.5 Percentage of Participants
|
|
Partial Seizure (Type I) Responder Rate (Percent) During the Up-titration/Conversion Phase and by Visit During the Maintenance Phase
Maintenance Visits 5-6 (weeks 24-36)
|
68.2 Percentage of Participants
|
|
Partial Seizure (Type I) Responder Rate (Percent) During the Up-titration/Conversion Phase and by Visit During the Maintenance Phase
Maintenance Visits 6-7 (weeks 36-48)
|
71.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: Subjects with up to 24 weeks of exposurePopulation: Intention to Treat (ITT) subjects with \<= 24 Weeks of Exposure and treatment period seizure data
For subjects with up to 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase.
Outcome measures
| Measure |
Levetiracetam
n=51 Participants
Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
|
|---|---|
|
Partial Seizure (Type I) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
|
0.00 Percentage of Days
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Subjects with greater than 24 weeks of exposurePopulation: Intention to Treat (ITT) Subjects with \> 24 Weeks of Exposure and treatment period seizure data
For subjects with greater than 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase.
Outcome measures
| Measure |
Levetiracetam
n=203 Participants
Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
|
|---|---|
|
Partial Seizure (Type I) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
|
61.49 Percentage of days
Interval 0.0 to 94.07
|
SECONDARY outcome
Timeframe: Subjects with up to 24 weeks of exposurePopulation: Intention to Treat (ITT) Subjects with \<= 24 Weeks of Exposure and treatment period seizure data
For subjects with up to 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase.
Outcome measures
| Measure |
Levetiracetam
n=51 Participants
Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
|
|---|---|
|
Total Seizure (Type I, II, III) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
|
0.00 Percentage of Days
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Subjects with greater than 24 weeks of exposurePopulation: Intention to Treat (ITT) subjects with \> 24 weeks of exposure and treatment period seizure data
For subjects with greater than 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase.
Outcome measures
| Measure |
Levetiracetam
n=203 Participants
Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
|
|---|---|
|
Total Seizure (Type I, II, III) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
|
58.41 Percentage of Days
Interval 0.0 to 93.81
|
SECONDARY outcome
Timeframe: greater than or equal to 24 weeks, greater than or equal to 40 weeksPopulation: 255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 1 was missing treatment period seizure data leaving a sample size of 254. Of these 254 subjects 233 continued into the maintenance period.
The measure description is the product limit adjusted percent of subjects seizure free starting from the beginning of the Maintenance Period. The up-titration period is the up to 6 week period of increasing dose prior to the Maintenance Period. The Maintenance Period is the period of stable dosing, subsquent to the up-titration period, which could last from 42 to 48 weeks.
Outcome measures
| Measure |
Levetiracetam
n=233 Participants
Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
|
|---|---|
|
Total Seizure (Type I, II, III) Continuously Seizure Free During the Maintenance Period
>= 24 Weeks
|
16.5 Percentage of Participants
|
|
Total Seizure (Type I, II, III) Continuously Seizure Free During the Maintenance Period
>= 40 Weeks
|
14.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Evaluation period (48 weeks)Population: 255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 1 was missing treatment period seizure data.
Type I Seizure is a partial onset Seizure (see International League Against Epilepsy definitions). Type II Seizure is a Generalized Seizure (see International League Against Epilepsy definitions). Type III Seizure is a Unknown Seizure Type (see International League Against Epilepsy definitions). A subject could experience more than one seizure type.
Outcome measures
| Measure |
Levetiracetam
n=254 Participants
Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
|
|---|---|
|
Percent of Subjects With Each Seizure Type During the Evaluation Period
Type I
|
88.6 Percentage of Participants
|
|
Percent of Subjects With Each Seizure Type During the Evaluation Period
Type II
|
12.9 Percentage of Participants
|
|
Percent of Subjects With Each Seizure Type During the Evaluation Period
Type III
|
7.1 Percentage of Participants
|
SECONDARY outcome
Timeframe: End of Evaluation period (week 48 or at point of early discontinuation)Population: Intention to Treat (ITT) subjects for whom the assessment was performed
There are 7 categories, 3 for improvement (Marked improvement, Moderate improvement, Slight improvement), 3 for worsening (Slight worsening, Moderate worsening, Marked worsening), and 1 for no change (No change).
Outcome measures
| Measure |
Levetiracetam
n=222 Participants
Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
|
|---|---|
|
Investigator Global Evaluation Scale
Improved
|
76.1 Percentage of Participants
|
|
Investigator Global Evaluation Scale
No Change
|
15.3 Percentage of Participants
|
|
Investigator Global Evaluation Scale
Worsened
|
8.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: End of Evaluation period (week 48 or at point of early discontinuation)Population: Intention to Treat (ITT) subjects for whom the assessment was performed
There are 7 categories, 3 for improvement (Marked improvement, Moderate improvement, Slight improvement), 3 for worsening (Slight worsening, Moderate worsening, Marked worsening), and 1 for no change (No change).
Outcome measures
| Measure |
Levetiracetam
n=214 Participants
Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
|
|---|---|
|
Parent/Guardian Global Evaluation Scale
Improved
|
75.7 Percentage of Participants
|
|
Parent/Guardian Global Evaluation Scale
No Change
|
12.6 Percentage of Participants
|
|
Parent/Guardian Global Evaluation Scale
Worsened
|
11.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: End of Evaluation period (week 48 or at point of early discontinuation)Population: Intention to Treat (ITT) subjects \>= 8 years old for whom the assessment was performed
There are 7 categories, 3 for improvement (Marked improvement, Moderate improvement, Slight improvement), 3 for worsening (Slight worsening, Moderate worsening, Marked worsening), and 1 for no change (No change).
Outcome measures
| Measure |
Levetiracetam
n=71 Participants
Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
|
|---|---|
|
Subject (>=8 Years Old) Global Evaluation Scale
Improved
|
78.9 Percentage of Participants
|
|
Subject (>=8 Years Old) Global Evaluation Scale
No Change
|
15.5 Percentage of Participants
|
|
Subject (>=8 Years Old) Global Evaluation Scale
Worsened
|
5.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline to Visit 5 (Week 24) and Visit 7 (Week 48)Population: At baseline there were 98 subjects with valid Memory Screen composite scores (mean=85.5, standard deviation=18.7). Of these 98 subjects, 87 had valid scores at Visit 5 (week 24) and 80 at Visit 7 (week 48).
The Leiter-R AM battery has 10 subtests. The raw scores of the subtests are converted into scaled scores. Six composite scores are constructed from the 10 subtest scaled scores. The Memory Screen is one of them. It is composed of 2 subtests the Associated Pairs and Forward Memory. The sum of the Associated Pairs and Forward Memory subtest scaled scores are converted into a Memory composite score normally distributed with a mean and standard deviation of 100 (±15). Higher scores and positive changes from baseline are better. The range of the Memory Screen composite score is 44 to 155.
Outcome measures
| Measure |
Levetiracetam
n=87 Participants
Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
|
|---|---|
|
Leiter-R Associated Memory (AM) Memory Screen Composite Score Change From Baseline to Visit 5 (Week 24) and Visit 7 (Week 48) (4 to 16 Year Olds)
Visit 5 (week 24)
|
4.8 Score on a scale
Standard Deviation 12.6
|
|
Leiter-R Associated Memory (AM) Memory Screen Composite Score Change From Baseline to Visit 5 (Week 24) and Visit 7 (Week 48) (4 to 16 Year Olds)
Visit 7 (week 48)
|
4.5 Score on a scale
Standard Deviation 15.3
|
SECONDARY outcome
Timeframe: Visit 5 (Week 24)Population: The Bayley Scale of Infant Development (BSID) II assessment was performed only at selected sites where a neuropsychologist was available. Both a valid baseline and Visit 5 (week 24) assessment had to be present.
This score is obtained from a total raw score which is the sum of a battery of individual questions. It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (\>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (\<=69). Changes from baseline are then further categorized where 'Improved' is any positive category change, 'Stable' is no category change, and 'Worsened' is any negative category change, from baseline.
Outcome measures
| Measure |
Levetiracetam
n=30 Participants
Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
|
|---|---|
|
Bayley Scale of Infant Development (BSID) II Mental Development Index Scores Classification Shift From Baseline at Visit 5 (Week 24) (1 Month to < 4 Year Olds)
Worsened
|
5 Number of subjects
|
|
Bayley Scale of Infant Development (BSID) II Mental Development Index Scores Classification Shift From Baseline at Visit 5 (Week 24) (1 Month to < 4 Year Olds)
Stable
|
21 Number of subjects
|
|
Bayley Scale of Infant Development (BSID) II Mental Development Index Scores Classification Shift From Baseline at Visit 5 (Week 24) (1 Month to < 4 Year Olds)
Improved
|
4 Number of subjects
|
SECONDARY outcome
Timeframe: Visit 7 (week 48)Population: The Bayley Scale of Infant Development (BSID) II assessment was performed only at selected sites where a neuropsychologist was available. Both a valid baseline and Visit 7 (week 48) assessment had to be present.
This score is obtained from a total raw score which is the sum of a battery of individual questions. It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (\>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (\<=69). Changes from baseline are then further categorized where 'Improved' is any positive category change, 'Stable' is no category change, and 'Worsened' is any negative category change, from baseline.
Outcome measures
| Measure |
Levetiracetam
n=25 Participants
Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
|
|---|---|
|
Bayley Scale of Infant Development (BSID) II Mental Development Index Scores Classification Shift From Baseline at Visit 7 (Week 48) (1 Month to < 4 Year Olds)
Worsened
|
7 Number of subjects
|
|
Bayley Scale of Infant Development (BSID) II Mental Development Index Scores Classification Shift From Baseline at Visit 7 (Week 48) (1 Month to < 4 Year Olds)
Stable
|
17 Number of subjects
|
|
Bayley Scale of Infant Development (BSID) II Mental Development Index Scores Classification Shift From Baseline at Visit 7 (Week 48) (1 Month to < 4 Year Olds)
Improved
|
1 Number of subjects
|
SECONDARY outcome
Timeframe: Visit 5 (week 24)Population: The Bayley Scale of Infant Development (BSID) II assessment was performed only at selected sites where a neuropsychologist was available. Both a valid baseline and Visit 5 (week 24) assessment had to be present.
This score is obtained from a total raw score which is the sum of a battery of individual questions. It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (\>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (\<=69). Changes from baseline are then further categorized where 'Improved' is any positive category change, 'Stable' is no category change, and 'Worsened' is any negative category change, from baseline.
Outcome measures
| Measure |
Levetiracetam
n=29 Participants
Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
|
|---|---|
|
Bayley Scale of Infant Development (BSID) II Psychomotor Development Index Scores Classification Shift From Baseline at Visit 5 (Week 24) (1 Month to < 4 Year Old)
Worsened
|
1 Number of subjects
|
|
Bayley Scale of Infant Development (BSID) II Psychomotor Development Index Scores Classification Shift From Baseline at Visit 5 (Week 24) (1 Month to < 4 Year Old)
Stable
|
20 Number of subjects
|
|
Bayley Scale of Infant Development (BSID) II Psychomotor Development Index Scores Classification Shift From Baseline at Visit 5 (Week 24) (1 Month to < 4 Year Old)
Improved
|
8 Number of subjects
|
SECONDARY outcome
Timeframe: Visit 7 (week 48)Population: The Bayley Scale of Infant Development (BSID) II assessment was performed only at selected sites where a neuropsychologist was available. Both a valid baseline and Visit 7 (week 48) assessment had to be present.
This score is obtained from a total raw score which is the sum of a battery of individual questions. It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (\>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (\<=69). Changes from baseline are then further categorized where 'Improved' is any positive category change, 'Stable' is no category change, and 'Worsened' is any negative category change, from baseline.
Outcome measures
| Measure |
Levetiracetam
n=24 Participants
Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
|
|---|---|
|
Bayley Scale of Infant Development (BSID) II Psychomotor Development Index Scores Classification Shift From Baseline at Visit 7 (Week 48) (1 Month to < 4 Year Old)
Worsened
|
1 Number of subjects
|
|
Bayley Scale of Infant Development (BSID) II Psychomotor Development Index Scores Classification Shift From Baseline at Visit 7 (Week 48) (1 Month to < 4 Year Old)
Stable
|
15 Number of subjects
|
|
Bayley Scale of Infant Development (BSID) II Psychomotor Development Index Scores Classification Shift From Baseline at Visit 7 (Week 48) (1 Month to < 4 Year Old)
Improved
|
8 Number of subjects
|
Adverse Events
Levetiracetam
Serious adverse events
| Measure |
Levetiracetam
n=255 participants at risk
Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.39%
1/255 • Number of events 1 • Up to 1 year
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.39%
1/255 • Number of events 1 • Up to 1 year
|
|
Congenital, familial and genetic disorders
Hip dysplasia
|
0.39%
1/255 • Number of events 1 • Up to 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
0.39%
1/255 • Number of events 1 • Up to 1 year
|
|
Gastrointestinal disorders
Constipation
|
0.39%
1/255 • Number of events 1 • Up to 1 year
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.39%
1/255 • Number of events 1 • Up to 1 year
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.39%
1/255 • Number of events 1 • Up to 1 year
|
|
General disorders
Influenza like illness
|
0.39%
1/255 • Number of events 1 • Up to 1 year
|
|
General disorders
Pyrexia
|
1.6%
4/255 • Number of events 4 • Up to 1 year
|
|
Investigations
Hepatic enzyme increased
|
0.39%
1/255 • Number of events 1 • Up to 1 year
|
|
Investigations
Transaminases increased
|
0.39%
1/255 • Number of events 1 • Up to 1 year
|
|
Infections and infestations
Bacteraemia
|
0.39%
1/255 • Number of events 1 • Up to 1 year
|
|
Infections and infestations
Bronchitis
|
0.39%
1/255 • Number of events 1 • Up to 1 year
|
|
Infections and infestations
Exanthema subitum
|
0.39%
1/255 • Number of events 1 • Up to 1 year
|
|
Infections and infestations
Gastroenteritis
|
0.39%
1/255 • Number of events 1 • Up to 1 year
|
|
Infections and infestations
Gastroenteritis adenovirus
|
0.39%
1/255 • Number of events 1 • Up to 1 year
|
|
Infections and infestations
Influenza
|
0.39%
1/255 • Number of events 1 • Up to 1 year
|
|
Infections and infestations
Nasopharyngitis
|
0.39%
1/255 • Number of events 1 • Up to 1 year
|
|
Infections and infestations
Pneumonia
|
2.4%
6/255 • Number of events 7 • Up to 1 year
|
|
Infections and infestations
Respiratory tract infection viral
|
0.39%
1/255 • Number of events 1 • Up to 1 year
|
|
Infections and infestations
Septic shock
|
0.39%
1/255 • Number of events 1 • Up to 1 year
|
|
Infections and infestations
Upper respiratory tract infection
|
0.78%
2/255 • Number of events 3 • Up to 1 year
|
|
Infections and infestations
Viral infection
|
2.0%
5/255 • Number of events 5 • Up to 1 year
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.39%
1/255 • Number of events 1 • Up to 1 year
|
|
Injury, poisoning and procedural complications
Feeding tube complication
|
0.39%
1/255 • Number of events 1 • Up to 1 year
|
|
Injury, poisoning and procedural complications
Head injury
|
0.78%
2/255 • Number of events 2 • Up to 1 year
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.39%
1/255 • Number of events 1 • Up to 1 year
|
|
Metabolism and nutrition disorders
Feeding disorder of infancy or early childhood
|
0.39%
1/255 • Number of events 1 • Up to 1 year
|
|
Nervous system disorders
Brain oedema
|
0.78%
2/255 • Number of events 2 • Up to 1 year
|
|
Nervous system disorders
Convulsion
|
7.1%
18/255 • Number of events 22 • Up to 1 year
|
|
Nervous system disorders
Infantile spasms
|
0.39%
1/255 • Number of events 1 • Up to 1 year
|
|
Nervous system disorders
Partial seizures with secondary generalisation
|
0.39%
1/255 • Number of events 1 • Up to 1 year
|
|
Nervous system disorders
Status epilepticus
|
2.4%
6/255 • Number of events 14 • Up to 1 year
|
|
Psychiatric disorders
Crying
|
0.39%
1/255 • Number of events 2 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.78%
2/255 • Number of events 2 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.39%
1/255 • Number of events 1 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.39%
1/255 • Number of events 1 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.78%
2/255 • Number of events 2 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.78%
2/255 • Number of events 2 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.78%
2/255 • Number of events 2 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.78%
2/255 • Number of events 2 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.39%
1/255 • Number of events 1 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.39%
1/255 • Number of events 1 • Up to 1 year
|
|
Surgical and medical procedures
Oesophagogastric fundoplasty
|
0.39%
1/255 • Number of events 1 • Up to 1 year
|
Other adverse events
| Measure |
Levetiracetam
n=255 participants at risk
Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
7.1%
18/255 • Number of events 24 • Up to 1 year
|
|
Gastrointestinal disorders
Diarrhoea
|
13.3%
34/255 • Number of events 45 • Up to 1 year
|
|
Gastrointestinal disorders
Vomiting
|
16.1%
41/255 • Number of events 62 • Up to 1 year
|
|
General disorders
Irritability
|
10.6%
27/255 • Number of events 33 • Up to 1 year
|
|
General disorders
Pyrexia
|
31.8%
81/255 • Number of events 131 • Up to 1 year
|
|
Infections and infestations
Bronchitis
|
6.3%
16/255 • Number of events 22 • Up to 1 year
|
|
Infections and infestations
Ear infection
|
7.1%
18/255 • Number of events 29 • Up to 1 year
|
|
Infections and infestations
Influenza
|
6.3%
16/255 • Number of events 22 • Up to 1 year
|
|
Infections and infestations
Nasopharyngitis
|
14.9%
38/255 • Number of events 53 • Up to 1 year
|
|
Infections and infestations
Otitis media
|
8.2%
21/255 • Number of events 34 • Up to 1 year
|
|
Infections and infestations
Pharyngitis
|
5.9%
15/255 • Number of events 30 • Up to 1 year
|
|
Infections and infestations
Rhinitis
|
5.5%
14/255 • Number of events 20 • Up to 1 year
|
|
Infections and infestations
Upper respiratory tract infection
|
24.3%
62/255 • Number of events 105 • Up to 1 year
|
|
Nervous system disorders
Somnolence
|
7.8%
20/255 • Number of events 24 • Up to 1 year
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.5%
14/255 • Number of events 17 • Up to 1 year
|
|
Nervous system disorders
Convulsion
|
6.7%
17/255 • Number of events 20 • Up to 1 year
|
|
Nervous system disorders
Headache
|
12.2%
31/255 • Number of events 46 • Up to 1 year
|
|
Psychiatric disorders
Aggression
|
5.9%
15/255 • Number of events 17 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.4%
29/255 • Number of events 39 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
5.5%
14/255 • Number of events 20 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.4%
24/255 • Number of events 28 • Up to 1 year
|
Additional Information
UCB Clinical Trial Call Center
UCB Pharma
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 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