Clinical Trial Results:
A Multi-Center, Open-Label, Long-Term, Follow-Up Study Of The Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures
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Summary
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EudraCT number |
2004-000200-40 |
Trial protocol |
CZ GB BE IT HU |
Global end of trial date |
24 Jun 2008
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Results information
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Results version number |
v1(current) |
This version publication date |
30 Jun 2016
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First version publication date |
25 Jul 2015
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
N01148
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00152516 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
UCB Biosciences Inc.
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Sponsor organisation address |
8010 Arco Corporate Drive, Raleigh, United States, NC 27617
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Public contact |
CTRRD, UCB Biosciences GmbH, +49 2173481515, clinicaltrials@ucb.com
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Scientific contact |
CTRRD, UCB Biosciences GmbH, +49 2173481515, clinicaltrials@ucb.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
08 Aug 2008
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
24 Jun 2008
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective of this study is to obtain long-term descriptive safety and efficacy data in pediatric epileptic patients with partial onset seizures receiving long-term treatment with levetiracetam at individualized doses. This study in conjunction with Study N157 (NCT00150709) (UCBs other long-term, follow-up pediatric study) will be used to fulfill the requirement from the FDA written request to determine the long-term safety of levetiracetam as adjunctive therapy in the treatment of partial onset seizures in pediatric patients.
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Protection of trial subjects |
Before any study procedures were initiated for any subject in this study, an IRB/IEC approved written informed consent form and assent form, where appropriate, were to be properly executed and documented.
Selection criteria for the study were specified globally in the protocol and were further clarified in country specific amendments to the protocol.
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Background therapy |
Concomitant anti epileptic drugs and other medication were allowed as specified in the study protocol. | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
23 Oct 2004
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
South Africa: 7
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Country: Number of subjects enrolled |
Czech Republic: 9
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Country: Number of subjects enrolled |
Germany: 11
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Country: Number of subjects enrolled |
Hungary: 4
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Country: Number of subjects enrolled |
Romania: 7
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Country: Number of subjects enrolled |
Poland: 2
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Country: Number of subjects enrolled |
Russian Federation: 7
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Country: Number of subjects enrolled |
Brazil: 29
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Country: Number of subjects enrolled |
Mexico: 6
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Country: Number of subjects enrolled |
France: 7
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Country: Number of subjects enrolled |
Italy: 6
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Country: Number of subjects enrolled |
India: 20
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Country: Number of subjects enrolled |
Canada: 11
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Country: Number of subjects enrolled |
United States: 123
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Country: Number of subjects enrolled |
Belgium: 4
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Country: Number of subjects enrolled |
United Kingdom: 2
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Worldwide total number of subjects |
255
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EEA total number of subjects |
52
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
81
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Children (2-11 years) |
147
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Adolescents (12-17 years) |
27
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
102 sites in 17 countries participated in the study, of which 85 sites in 16 countries enrolled subjects in the study. | ||||||||||||||||||||||||||||||||||||||||
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Pre-assignment
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Screening details |
The country specific protocol amendment C2 (August 7, 2006) allowed direct enrollment from India, Australia, and New Zealand bypassing the blinded feeder studies N01009 (2004-000199-14/NCT00175890) and N01103 (2014-004396-23/NCT00105040). | ||||||||||||||||||||||||||||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||||||||||||||||||||||||
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Arms
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Arm title
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Levetiracetam | ||||||||||||||||||||||||||||||||||||||||
Arm 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. | ||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Levetiracetam
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Investigational medicinal product code |
IMP1
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Other name |
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Pharmaceutical forms |
Oral solution, Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Per protocol 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.
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Baseline characteristics reporting groups
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Reporting group title |
Levetiracetam
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Reporting 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. | ||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Levetiracetam
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Reporting 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. | ||
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End point title |
Percentage change (reduction) of partial (type I) seizure frequency per week from baseline over time during treatment period [1] | ||||||||||||
End point description |
Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.
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End point type |
Primary
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End point timeframe |
Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percentage change (reduction) of total (type I, II, III) seizure frequency per week from baseline over time during treatment period | ||||||||||||
End point description |
Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.
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End point type |
Secondary
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End point timeframe |
Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Partial (type I) seizure frequency per week over time during treatment period | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Total (type I, II, III) seizure frequency per week over time during treatment period | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change (reduction) from baseline in partial (type I) seizure frequency per week over time during treatment period | ||||||||||||
End point description |
Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.
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End point type |
Secondary
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End point timeframe |
Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change (reduction) from baseline in total (type I, II, III) seizure frequency per week over time during treatment period | ||||||||||||
End point description |
Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.
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End point type |
Secondary
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End point timeframe |
Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Partial seizure (type I) Responder rate (percent) during the up-titration/conversion phase and by visit during the maintenance phase | ||||||||||||||||||
End point 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.
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End point type |
Secondary
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End point 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)
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Partial seizure (type I) Maximum Seizure Free Interval (percentage of days belonging to a seizure free interval of 28 days or more) | ||||||||||
End point 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.
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End point type |
Secondary
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End point timeframe |
Subjects with up to 24 weeks of exposure
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| No statistical analyses for this end point | |||||||||||
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End point title |
Partial seizure (type I) Maximum Seizure Free Interval (percentage of days belonging to a seizure free interval of 28 days or more) | ||||||||||
End point 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.
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End point type |
Secondary
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End point timeframe |
Subjects with greater than 24 weeks of exposure
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| No statistical analyses for this end point | |||||||||||
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End point 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) | ||||||||||
End point 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.
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End point type |
Secondary
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End point timeframe |
Subjects with up to 24 weeks of exposure
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| No statistical analyses for this end point | |||||||||||
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End point 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) | ||||||||||
End point 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.
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End point type |
Secondary
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End point timeframe |
Subjects with greater than 24 weeks of exposure
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| No statistical analyses for this end point | |||||||||||
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End point title |
Total seizure (type I, II, III) Continuously Seizure Free during the maintenance period | ||||||||||||
End point 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.
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End point type |
Secondary
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End point timeframe |
Greater than or equal to 24 weeks, greater than or equal to 40 weeks
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percent of subjects with each seizure type during the evaluation period | ||||||||||||||
End point 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.
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End point type |
Secondary
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End point timeframe |
Evaluation period (48 weeks)
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Investigator Global Evaluation Scale | ||||||||||||||
End point 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).
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End point type |
Secondary
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End point timeframe |
End of Evaluation period (week 48 or at point of early discontinuation)
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Parent/Guardian Global Evaluation Scale | ||||||||||||||
End point 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).
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End point type |
Secondary
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End point timeframe |
End of Evaluation period (week 48 or at point of early discontinuation)
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Subject (>=8 years old) Global Evaluation Scale | ||||||||||||||
End point 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).
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End point type |
Secondary
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End point timeframe |
End of Evaluation period (week 48 or at point of early discontinuation)
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| No statistical analyses for this end point | |||||||||||||||
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End point 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) | ||||||||||||
End point 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.
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End point type |
Secondary
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End point timeframe |
Baseline to Visit 5 (Week 24) and Visit 7 (Week 48)
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| No statistical analyses for this end point | |||||||||||||
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End point 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) | ||||||||||||
End point 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.
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End point type |
Secondary
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End point timeframe |
Visit 5 (Week 24)
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| No statistical analyses for this end point | |||||||||||||
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End point 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) | ||||||||||||
End point 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.
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End point type |
Secondary
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End point timeframe |
Visit 7 (week 48)
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| No statistical analyses for this end point | |||||||||||||
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End point 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) | ||||||||||||
End point 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.
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End point type |
Secondary
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End point timeframe |
Visit 5 (week 24)
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| No statistical analyses for this end point | |||||||||||||
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End point 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) | ||||||||||||
End point 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.
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End point type |
Secondary
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End point timeframe |
Visit 7 (week 48)
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| No statistical analyses for this end point | |||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Up to 1 year
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
9.0
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Reporting groups
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Reporting group title |
Levetiracetam
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Reporting 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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12 Jul 2004 |
The primary reason for this amendment is to allow enrollment of a homogeneous patient population for testing with the Leiter-R and CBCL and to align the inclusion/exclusion criteria for N01148 with N01103 (2014-004396-23 / NCT00105040) and N01009 (2004-000199-14 / NCT00175890). Secondarily, correction of errors, updates to the study team and central lab, addition of a visit window to allow flexibility in visit scheduling, more accurate descriptions of the titration period length, drug packaging and pregnancy testing are also provided. |
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02 Sep 2005 |
This amendment serves to make revisions to the protocol summary, background information, study procedures, and treatment of patients sections of the protocol. Changes in the study procedures include the incorporation of an additional height assessment at Visit 7 and the addition of thyroid testing [thyroid-stimulating hormone (TSH)] at Visit 1 and Visit 7 to satisfy requirements imparted by the European Medicines Agency (EMEA). Changes in the protocol summary reflect the addition of possibly Argentina, India, Russia, Hungary, Poland, South Africa, and Croatia. Changes to the background information reflect the recent FDA approval of Keppra® for partial onset seizures in children, ages four and above. Changes in the treatment of patient section includes the removal of an appendix related to dosing and the addition of a statement related to IVRS. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/21095488 |
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