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Long-Term, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures

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ClinicalTrials.gov Identifier: NCT00152516
Recruitment Status : Completed
First Posted : September 9, 2005
Results First Posted : January 13, 2010
Last Update Posted : February 12, 2013
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Epilepsy, Partial
Intervention Drug: levetiracetam (LEV)
Enrollment 255
Recruitment Details 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
Pre-assignment Details Protocol amendment C2 (August 7, 2006) allowed direct enrollment from India, Australia, and New Zealand bypassing the blinded feeder studies N01009 and N01103.
Arm/Group Title Levetiracetam
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 255 [1]
Completed 180 [2]
Not Completed 75
Reason Not Completed
Adverse Event             18
Lack and Loss of Efficacy             30
Lost to Follow-up             5
Withdrawal by Subject             8
Protocol Violation             3
Other: Mother Refused To Cooperate             1
Other: Given Commercial Drug in Error             2
Other: Parents Withdrew Consent             2
Other: Non-Compliance             2
Other: Primary Care Physician's Decision             1
Other: Moved Out Of State             1
Other: Underwent Surgery for Epilepsy             1
Other: Sz Worsening, Seeking 2nd Opinion             1
[1]
Subjects that were dispensed at least 1 dose of study medication
[2]
Subjects ongoing until study close-out
Arm/Group Title Levetiracetam
Hide Arm/Group Description 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 Number of Baseline Participants 255
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 255 participants
<=18 years
255
 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 255 participants
5.28  (4.69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 255 participants
Female
116
  45.5%
Male
139
  54.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 255 participants
United States 123
Russian Federation 7
Italy 6
United Kingdom 2
India 20
France 7
Czech Republic 9
Hungary 4
Mexico 6
Canada 11
Poland 2
Brazil 29
Belgium 4
Romania 7
South Africa 7
Germany 11
1.Primary Outcome
Title Percentage Change (Reduction) of Partial (Type I) Seizure Frequency Per Week From Baseline Over Time During Treatment Period.
Hide Description Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.
Time Frame Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
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 Number of Participants Analyzed 247
Median (Inter-Quartile Range)
Unit of Measure: percent reduction in seizures Per Week
Up-titration/Conversion
51.06
(-10.70 to 91.59)
Maintenance
68.87
(-3.60 to 96.61)
2.Secondary Outcome
Title Percentage Change (Reduction) of Total (Type I, II, III) Seizure Frequency Per Week From Baseline Over Time During Treatment Period.
Hide Description Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.
Time Frame Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
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 Number of Participants Analyzed 248
Median (Inter-Quartile Range)
Unit of Measure: Percent Reduction in Seizures per Week
Up-titration/Conversion Period
47.44
(-21.18 to 88.70)
Maintenance Period
66.02
(-3.98 to 95.00)
3.Secondary Outcome
Title Partial (Type I) Seizure Frequency Per Week Over Time During Treatment Period.
Hide Description [Not Specified]
Time Frame Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
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 Number of Participants Analyzed 254
Median (Inter-Quartile Range)
Unit of Measure: Seizures Per Week
Up-titration/Conversion Period
2.85
(0.23 to 26.30)
Maintenance Period
1.49
(0.07 to 17.89)
4.Secondary Outcome
Title Total (Type I, II, III) Seizure Frequency Per Week Over Time During Treatment Period.
Hide Description [Not Specified]
Time Frame Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
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 Number of Participants Analyzed 254
Median (Inter-Quartile Range)
Unit of Measure: Seizures Per Week
Up-titration/Conversion Period
3.15
(0.25 to 31.17)
Maintenance Period
1.91
(0.09 to 24.86)
5.Secondary Outcome
Title Change (Reduction) From Baseline in Partial (Type I) Seizure Frequency Per Week Over Time During Treatment Period
Hide Description Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.
Time Frame Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
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 Number of Participants Analyzed 250
Median (Inter-Quartile Range)
Unit of Measure: Seizures Per Week
Up-titration/Conversion Period
0.72
(-0.81 to 7.14)
Maintenance Period
0.93
(-0.33 to 8.99)
6.Secondary Outcome
Title Change (Reduction) From Baseline in Total (Type I, II, III) Seizure Frequency Per Week Over Time During Treatment Period
Hide Description Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.
Time Frame Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
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 Number of Participants Analyzed 250
Median (Inter-Quartile Range)
Unit of Measure: Seizures Per Week
Up-titration/Conversion Period
0.69
(-0.89 to 7.84)
Maintenance Period
0.93
(-0.33 to 10.70)
7.Secondary Outcome
Title Partial Seizure (Type I) Responder Rate (Percent) During the Up-titration/Conversion Phase and by Visit During the Maintenance Phase
Hide Description

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.

Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
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 Number of Participants Analyzed 247
Measure Type: Number
Unit of Measure: Percentage of Participants
Up-titration/Conversion (4 weeks) 50.6
Maintenance Visits 3-4 (weeks 4-14, 6-15, or 8-16) 59.8
Maint. Visits 4-5 (weeks 14-24, 15-24, or 16-24); 65.5
Maintenance Visits 5-6 (weeks 24-36) 68.2
Maintenance Visits 6-7 (weeks 36-48) 71.8
8.Secondary Outcome
Title Partial Seizure (Type I) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
Hide Description 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.
Time Frame Subjects with up to 24 weeks of exposure
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) subjects with <= 24 Weeks of Exposure and treatment period seizure data
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
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 Number of Participants Analyzed 51
Median (Inter-Quartile Range)
Unit of Measure: Percentage of Days
0.00
(0.00 to 0.00)
9.Secondary Outcome
Title Partial Seizure (Type I) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
Hide Description 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.
Time Frame Subjects with greater than 24 weeks of exposure
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) Subjects with > 24 Weeks of Exposure and treatment period seizure data
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
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 Number of Participants Analyzed 203
Median (Inter-Quartile Range)
Unit of Measure: Percentage of days
61.49
(0.00 to 94.07)
10.Secondary Outcome
Title Total Seizure (Type I, II, III) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
Hide Description 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.
Time Frame Subjects with up to 24 weeks of exposure
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) Subjects with <= 24 Weeks of Exposure and treatment period seizure data
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
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 Number of Participants Analyzed 51
Median (Inter-Quartile Range)
Unit of Measure: Percentage of Days
0.00
(0.00 to 0.00)
11.Secondary Outcome
Title Total Seizure (Type I, II, III) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
Hide Description 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.
Time Frame Subjects with greater than 24 weeks of exposure
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) subjects with > 24 weeks of exposure and treatment period seizure data
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
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 Number of Participants Analyzed 203
Median (Inter-Quartile Range)
Unit of Measure: Percentage of Days
58.41
(0.00 to 93.81)
12.Secondary Outcome
Title Total Seizure (Type I, II, III) Continuously Seizure Free During the Maintenance Period
Hide Description

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.

Time Frame greater than or equal to 24 weeks, greater than or equal to 40 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
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 Number of Participants Analyzed 233
Measure Type: Number
Unit of Measure: Percentage of Participants
>= 24 Weeks 16.5
>= 40 Weeks 14.7
13.Secondary Outcome
Title Percent of Subjects With Each Seizure Type During the Evaluation Period
Hide Description

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.

Time Frame Evaluation period (48 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
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 Number of Participants Analyzed 254
Measure Type: Number
Unit of Measure: Percentage of Participants
Type I 88.6
Type II 12.9
Type III 7.1
14.Secondary Outcome
Title Investigator Global Evaluation Scale
Hide Description 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).
Time Frame End of Evaluation period (week 48 or at point of early discontinuation)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) subjects for whom the assessment was performed
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
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 Number of Participants Analyzed 222
Measure Type: Number
Unit of Measure: Percentage of Participants
Improved 76.1
No Change 15.3
Worsened 8.6
15.Secondary Outcome
Title Parent/Guardian Global Evaluation Scale
Hide Description 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).
Time Frame End of Evaluation period (week 48 or at point of early discontinuation)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) subjects for whom the assessment was performed
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
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 Number of Participants Analyzed 214
Measure Type: Number
Unit of Measure: Percentage of Participants
Improved 75.7
No Change 12.6
Worsened 11.7
16.Secondary Outcome
Title Subject (>=8 Years Old) Global Evaluation Scale
Hide Description 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).
Time Frame End of Evaluation period (week 48 or at point of early discontinuation)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) subjects >= 8 years old for whom the assessment was performed
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
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 Number of Participants Analyzed 71
Measure Type: Number
Unit of Measure: Percentage of Participants
Improved 78.9
No Change 15.5
Worsened 5.6
17.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame Baseline to Visit 5 (Week 24) and Visit 7 (Week 48)
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
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 Number of Participants Analyzed 87
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Visit 5 (week 24) 4.8  (12.6)
Visit 7 (week 48) 4.5  (15.3)
18.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame Visit 5 (Week 24)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
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 Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: Number of subjects
Worsened 5
Stable 21
Improved 4
19.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame Visit 7 (week 48)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
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 Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: Number of subjects
Worsened 7
Stable 17
Improved 1
20.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame Visit 5 (week 24)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
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 Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Number of subjects
Worsened 1
Stable 20
Improved 8
21.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame Visit 7 (week 48)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
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 Number of Participants Analyzed 24
Measure Type: Number
Unit of Measure: Number of subjects
Worsened 1
Stable 15
Improved 8
Time Frame Up to 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Levetiracetam
Hide Arm/Group Description 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.
All-Cause Mortality
Levetiracetam
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Levetiracetam
Affected / at Risk (%) # Events
Total   46/255 (18.04%)    
Blood and lymphatic system disorders   
Neutropenia * 1  1/255 (0.39%)  1
Thrombocytopenia * 1  1/255 (0.39%)  1
Congenital, familial and genetic disorders   
Hip dysplasia * 1  1/255 (0.39%)  1
Gastrointestinal disorders   
Abdominal pain * 1  1/255 (0.39%)  1
Constipation * 1  1/255 (0.39%)  1
Gastrooesophageal reflux disease * 1  1/255 (0.39%)  1
Small intestinal obstruction * 1  1/255 (0.39%)  1
General disorders   
Influenza like illness * 1  1/255 (0.39%)  1
Pyrexia * 1  4/255 (1.57%)  4
Infections and infestations   
Bacteraemia * 1  1/255 (0.39%)  1
Bronchitis * 1  1/255 (0.39%)  1
Exanthema subitum * 1  1/255 (0.39%)  1
Gastroenteritis * 1  1/255 (0.39%)  1
Gastroenteritis adenovirus * 1  1/255 (0.39%)  1
Influenza * 1  1/255 (0.39%)  1
Nasopharyngitis * 1  1/255 (0.39%)  1
Pneumonia * 1  6/255 (2.35%)  7
Respiratory tract infection viral * 1  1/255 (0.39%)  1
Septic shock * 1  1/255 (0.39%)  1
Upper respiratory tract infection * 1  2/255 (0.78%)  3
Viral infection * 1  5/255 (1.96%)  5
Injury, poisoning and procedural complications   
Drug toxicity * 1  1/255 (0.39%)  1
Feeding tube complication * 1  1/255 (0.39%)  1
Head injury * 1  2/255 (0.78%)  2
Pneumothorax traumatic * 1  1/255 (0.39%)  1
Investigations   
Hepatic enzyme increased * 1  1/255 (0.39%)  1
Transaminases increased * 1  1/255 (0.39%)  1
Metabolism and nutrition disorders   
Feeding disorder of infancy or early childhood * 1  1/255 (0.39%)  1
Nervous system disorders   
Brain oedema * 1  2/255 (0.78%)  2
Convulsion * 1  18/255 (7.06%)  22
Infantile spasms * 1  1/255 (0.39%)  1
Partial seizures with secondary generalisation * 1  1/255 (0.39%)  1
Status epilepticus * 1  6/255 (2.35%)  14
Psychiatric disorders   
Crying * 1  1/255 (0.39%)  2
Respiratory, thoracic and mediastinal disorders   
Aspiration * 1  2/255 (0.78%)  2
Choking * 1  1/255 (0.39%)  1
Hypoxia * 1  1/255 (0.39%)  1
Obstructive airways disorder * 1  2/255 (0.78%)  2
Pneumonia aspiration * 1  2/255 (0.78%)  2
Respiratory disorder * 1  2/255 (0.78%)  2
Respiratory failure * 1  2/255 (0.78%)  2
Tonsillar hypertrophy * 1  1/255 (0.39%)  1
Skin and subcutaneous tissue disorders   
Rash * 1  1/255 (0.39%)  1
Surgical and medical procedures   
Oesophagogastric fundoplasty * 1  1/255 (0.39%)  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   206/255 (80.78%)    
Gastrointestinal disorders   
Constipation * 1  18/255 (7.06%)  24
Diarrhoea * 1  34/255 (13.33%)  45
Vomiting * 1  41/255 (16.08%)  62
General disorders   
Irritability * 1  27/255 (10.59%)  33
Pyrexia * 1  81/255 (31.76%)  131
Infections and infestations   
Bronchitis * 1  16/255 (6.27%)  22
Ear infection * 1  18/255 (7.06%)  29
Influenza * 1  16/255 (6.27%)  22
Nasopharyngitis * 1  38/255 (14.90%)  53
Otitis media * 1  21/255 (8.24%)  34
Pharyngitis * 1  15/255 (5.88%)  30
Rhinitis * 1  14/255 (5.49%)  20
Upper respiratory tract infection * 1  62/255 (24.31%)  105
Metabolism and nutrition disorders   
Decreased appetite * 1  14/255 (5.49%)  17
Nervous system disorders   
Somnolence * 1  20/255 (7.84%)  24
Convulsion * 1  17/255 (6.67%)  20
Headache * 1  31/255 (12.16%)  46
Psychiatric disorders   
Aggression * 1  15/255 (5.88%)  17
Respiratory, thoracic and mediastinal disorders   
Cough * 1  29/255 (11.37%)  39
Pharyngolaryngeal pain * 1  14/255 (5.49%)  20
Skin and subcutaneous tissue disorders   
Rash * 1  24/255 (9.41%)  28
*
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 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 Pharma
Phone: +1 877 822 9493
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00152516     History of Changes
Other Study ID Numbers: N01148
EudraCT number:2004-000200-40
First Submitted: September 7, 2005
First Posted: September 9, 2005
Results First Submitted: August 27, 2009
Results First Posted: January 13, 2010
Last Update Posted: February 12, 2013