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An Open Label Study of Levetiracetam in Japanese Pediatric Patients With Partial Seizures

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ClinicalTrials.gov Identifier: NCT01063764
Recruitment Status : Completed
First Posted : February 5, 2010
Results First Posted : June 19, 2012
Last Update Posted : March 5, 2015
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Japan Co. Ltd. )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Epilepsy
Partial Seizures
Intervention Drug: Levetiracetam
Enrollment 73
Recruitment Details Full Analysis Set (FAS) includes all subjects taking at least one dose of study medication. Per-Protocol Set (PPS) is a subset of the FAS, consisting of subjects without major protocol violations affecting the primary efficacy variable.
Pre-assignment Details Participant Flow refers to the Full Analysis Set. First Period started after Baseline (Week 0 to Week 8).
Arm/Group Title Levetiracetam
Hide Arm/Group Description
  • First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.
  • Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
  • Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped.
Period Title: 1st Period (From Week 8 to Week 22)
Started 73
Completed 62 [1]
Not Completed 11
Reason Not Completed
Adverse Event             4
Lack of Efficacy             6
Withdrawal by Subject             1
[1]
62 subjects completed the First Period, but 7 of these subjects did not enter the Second Period.
Period Title: 2nd Period (Week 22 to the End of Study)
Started 55 [1]
Completed 35
Not Completed 20
Reason Not Completed
Adverse Event             3
Lack of Efficacy             9
Withdrawal by Subject             7
Protocol Violation             1
[1]
7 subjects who completed Period 1 did not enter the Second Period.
Arm/Group Title Levetiracetam
Hide Arm/Group Description
  • First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.
  • Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
  • Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped.
Overall Number of Baseline Participants 73
Hide Baseline Analysis Population Description
Baseline Characteristics refer to the Full Analysis Set (FAS). FAS includes all subjects taking at least one dose of study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 73 participants
10.1  (3.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 73 participants
Female
32
  43.8%
Male
41
  56.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 73 participants
73
Age Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 73 participants
>=4 - <8 years 22
>=8 - <12 years 22
>=12 - <16 years 29
Body Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram (kg)
Number Analyzed 73 participants
32.43  (13.20)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeter (cm)
Number Analyzed 73 participants
134.55  (20.69)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kilogram / meter^2 (kg/m^2)
Number Analyzed 73 participants
17.15  (2.99)
Hospitalization Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 73 participants
Yes 0
No 73
1.Primary Outcome
Title Change From Baseline in Partial Seizure Frequency Per Week Over the 14-weeks Treatment Period
Hide Description

The change in partial seizure frequency from Baseline (B) over the Treatment Period (T) is given as a percentage reduction computed as:

(B values- T values) / B values x 100.

Positive values in percent reduction mean that the value decreased from Baseline during the first 14-week Period.

Frequency per week of partial seizures = (Total number of partial seizures in a certain Period/number of observation days in the Period) x 7.

Partial seizures can be classified into:

  • Simple partial seizures
  • Complex partial seizures
  • Partial seizures evolving to secondarily generalized seizures.
Time Frame From Baseline (Week 0-8) to the 14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22)); Week 0-22
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS).
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
  • First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.
  • Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
  • Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped.
Overall Number of Participants Analyzed 73
Median (95% Confidence Interval)
Unit of Measure: Percent reduction
43.21
(26.19 to 52.14)
2.Primary Outcome
Title Incidence of Treatment-Emergent Adverse Events (TEAEs) During the Second Period (up to Three Years Until the Time of Approval Granted)
Hide Description An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with the pharmaceutical product. Incidence of treatment-emergent AEs is reported by the percentage of subjects with at least one treatment-emergent AE.
Time Frame During the second Period from Visit 8 (Week 22) to the end of the Follow-up Period (up to three years until the time of approval granted)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS).
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
  • First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.
  • Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
  • Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped.
Overall Number of Participants Analyzed 55
Measure Type: Number
Unit of Measure: percentage of participants
98.2
3.Secondary Outcome
Title Change From Baseline in Partial Seizure Frequency Per Week Over the 10-week Evaluation Period
Hide Description

The change in partial seizure frequency from Baseline (B) over the Evaluation Period (E) is given as a percentage reduction computed as:

(B values- E values) / B values x 100. Positive values in percent reduction mean that the value decreased from Baseline to the 10-week Evaluation Period.

Frequency per week of partial seizures = (Total number of partial seizures in a certain Period/number of observation days in the Period) x 7.

Partial seizures can be classified into:

  • Simple partial seizures
  • Complex partial seizures
  • Partial seizures evolving to secondarily generalized seizures.
Time Frame From Baseline (Week 0-8) to the 10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 73 subjects in the FAS, 68 subjects had available data at Baseline and during the Evaluation Period.
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
  • First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.
  • Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
  • Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped.
Overall Number of Participants Analyzed 68
Median (95% Confidence Interval)
Unit of Measure: Percent reduction
39.02
(26.67 to 52.07)
4.Secondary Outcome
Title Partial Seizure Frequency Per Week Over the 14-weeks Treatment Period
Hide Description

The seizure frequency per week was calculated as:

Frequency per week of partial seizures = (Total number of partial seizures in the Treatment Period/number of days for observation in the Treatment Period) x 7. Partial seizures can be classified into one of the following three groups:

  • Simple partial seizures
  • Complex partial seizures
  • Partial seizures evolving to secondarily generalized seizures.
Time Frame 14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22))
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS). Only subjects having values unequal to zero over Baseline and values equal to or greater than zero over Treatment Period are included.
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
  • First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.
  • Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
  • Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped.
Overall Number of Participants Analyzed 73
Median (Inter-Quartile Range)
Unit of Measure: Seizures per week
3.92
(0.93 to 17.08)
5.Secondary Outcome
Title Partial Seizure Frequency Per Week Over the 10-weeks Evaluation Period
Hide Description

The seizure frequency per week was calculated as:

Frequency per week of partial seizures = (Total number of partial seizures in the Evaluation Period/number of days for observation in the Evaluation Period) x 7. Partial seizures can be classified into one of the following three groups:

  • Simple partial seizures
  • Complex partial seizures
  • Partial seizures evolving to secondarily generalized seizures.
Time Frame 10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS). Only subjects having values unequal to zero over Baseline and values equal to or greater than zero over Treatment Period are included.
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
  • First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.
  • Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
  • Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped.
Overall Number of Participants Analyzed 68
Median (Inter-Quartile Range)
Unit of Measure: Seizures per week
3.90
(0.86 to 17.26)
6.Secondary Outcome
Title Percentage of Partial Seizures 50 % Responders Over the 14-weeks Treatment Period
Hide Description

50 % responders are those subjects which have a 50 % or more reduction in the frequency of partial seizures from Baseline to the Treatment Period. The results show the percentage of participants that are 50 % responders.

Partial seizures can be classified into one of the following three groups:

  • Simple partial seizures
  • Complex partial seizures
  • Partial seizures evolving to secondarily generalized seizures.
Time Frame 14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22))
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS).
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
  • First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.
  • Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
  • Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped.
Overall Number of Participants Analyzed 73
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
38.4
(27.2 to 50.5)
7.Secondary Outcome
Title Percentage of Partial Seizures 50 % Responders Over the 10-weeks Evaluation Period
Hide Description

50 % responders are those subjects which have a 50 % or more reduction in the frequency of partial seizures from Baseline to the Evaluation Period. The results show the percentage of participants that are 50 % responders.

Partial seizures can be classified into one of the following three groups:

  • Simple partial seizures
  • Complex partial seizures
  • Partial seizures evolving to secondarily generalized seizures.
Time Frame 10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 73 subjects in the FAS, 68 subjects had available data over the Evaluation Period.
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
  • First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.
  • Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
  • Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped.
Overall Number of Participants Analyzed 68
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
38.2
(26.7 to 50.8)
8.Secondary Outcome
Title Number of Seizure-free Subjects Over the 14-weeks Treatment Period
Hide Description

Seizure-free means not having a seizure of type I (Partial seizure).

Partial seizures can be classified into one of the following three groups:

  • Simple partial seizures
  • Complex partial seizures
  • Partial seizures evolving to secondarily generalized seizures.
Time Frame 14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22))
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS).
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
  • First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.
  • Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
  • Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped.
Overall Number of Participants Analyzed 73
Measure Type: Number
Unit of Measure: participants
2
9.Secondary Outcome
Title Number of Seizure-free Subjects Over the 10-weeks Evaluation Period
Hide Description

Seizure-free means not having a seizure of type I (Partial seizure).

Partial seizures can be classified into one of the following three groups:

  • Simple partial seizures
  • Complex partial seizures
  • Partial seizures evolving to secondarily generalized seizures.
Time Frame 10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 73 subjects in the FAS, 68 subjects had available data over the Evaluation Period.
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
  • First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.
  • Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
  • Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped.
Overall Number of Participants Analyzed 68
Measure Type: Number
Unit of Measure: participants
3
10.Secondary Outcome
Title Incidence of Treatment-emergent Adverse Drug Reactions (ADRs) During the Second Period (up to Three Years Until the Time of Approval Granted)
Hide Description An Adverse Drug Reaction (ADR) is an Adverse Event for which a causal relationship between the product and the occurrence is suspected. Incidence of ADRs is reported by the number of subjects with at least one ADR.
Time Frame During the second Period from Visit 8 (Week 22) to the end of the Follow-up Period (up to three years until the time of approval granted)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS).
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
  • First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.
  • Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
  • Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped.
Overall Number of Participants Analyzed 55
Measure Type: Number
Unit of Measure: participants
15
11.Secondary Outcome
Title Change From Baseline in Partial Seizure Frequency Per Week for the Second Period (up to Three Years From Informed Consent Until the Time of Approval Granted)
Hide Description

The outcome was also calculated for each 3-month Period but here only the result for the total Second Evaluation Period (Second Period without following 6-weeks Withdrawal Period for withdrawers) is presented.

Change in partial seizure frequency from Baseline (B) over Second Evaluation Period (E) is given as a percentage reduction computed as:

(B values- E values) / B values x 100. Positive values in percent reduction show a decrease from Baseline. Frequency per week of partial seizures = (Total number of partial seizures in a certain Period/number of observation days in the Period) x 7.

Time Frame From Baseline (Week 0-8) until the time of approval granted (up to three years from date of informed consent (Week 0); without 6-weeks Withdrawal Period)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS).
Arm/Group Title Levetiracetam
Hide Arm/Group Description:
  • First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.
  • Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
  • Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped.
Overall Number of Participants Analyzed 55
Median (Inter-Quartile Range)
Unit of Measure: Percent reduction
41.32
(15.37 to 82.40)
Time Frame Adverse Events (AEs) were collected over the whole study from Baseline (Visit 2) over the complete First Period (14 weeks plus up to 6-week Down-titration and Follow-up) and the Second Period (Week 22 to the end of study).
Adverse Event Reporting Description AEs refer to the Full Analysis Set (FAS). FAS includes all subjects which received at least one dose of study medication.
 
Arm/Group Title Levetiracetam
Hide Arm/Group Description
  • First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.
  • Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
  • Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped.
All-Cause Mortality
Levetiracetam
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Levetiracetam
Affected / at Risk (%) # Events
Total   8/73 (10.96%)    
Eye disorders   
Strabismus * 1  1/73 (1.37%)  1
Gastrointestinal disorders   
Abdominal pain lower * 1  1/73 (1.37%)  1
Acetonaemic vomiting * 1  1/73 (1.37%)  2
Dental caries * 1  1/73 (1.37%)  1
Infections and infestations   
Gastroenteritis * 1  2/73 (2.74%)  2
Pneumonia * 1  1/73 (1.37%)  1
Injury, poisoning and procedural complications   
Near drowning * 1  1/73 (1.37%)  1
Nervous system disorders   
Convulsion * 1  2/73 (2.74%)  2
Status epilepticus * 1  1/73 (1.37%)  1
Psychiatric disorders   
Conversion disorder * 1  1/73 (1.37%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (14.0)
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   66/73 (90.41%)    
Eye disorders   
Conjunctivitis * 1  4/73 (5.48%)  5
Gastrointestinal disorders   
Diarrhoea * 1  9/73 (12.33%)  16
Nausea * 1  5/73 (6.85%)  5
Abdominal Pain * 1  5/73 (6.85%)  7
Constipation * 1  6/73 (8.22%)  7
Dental Caries * 1  5/73 (6.85%)  11
General disorders   
Pyrexia * 1  17/73 (23.29%)  32
Irritability * 1  4/73 (5.48%)  4
Infections and infestations   
Nasopharyngitis * 1  54/73 (73.97%)  205
Influenza * 1  20/73 (27.40%)  24
Upper respiratory tract infection * 1  12/73 (16.44%)  37
Gastroenteritis * 1  7/73 (9.59%)  13
Impetigo * 1  4/73 (5.48%)  4
Pharyngitis * 1  4/73 (5.48%)  4
Injury, poisoning and procedural complications   
Contusion * 1  8/73 (10.96%)  11
Excoriation * 1  6/73 (8.22%)  8
Wound * 1  5/73 (6.85%)  10
Arthropod bite * 1  4/73 (5.48%)  21
Metabolism and nutrition disorders   
Decreased appetite * 1  5/73 (6.85%)  5
Nervous system disorders   
Somnolence * 1  34/73 (46.58%)  48
Headache * 1  10/73 (13.70%)  20
Convulsion * 1  7/73 (9.59%)  8
Psychiatric disorders   
Agitation * 1  4/73 (5.48%)  4
Respiratory, thoracic and mediastinal disorders   
Epistaxis * 1  6/73 (8.22%)  8
Rhinorrhoea * 1  5/73 (6.85%)  10
Cough * 1  4/73 (5.48%)  5
Rhinitis allergic * 1  4/73 (5.48%)  4
Skin and subcutaneous tissue disorders   
Acne * 1  6/73 (8.22%)  6
Heat rash * 1  5/73 (6.85%)  5
Eczema * 1  4/73 (5.48%)  5
Pruritus * 1  4/73 (5.48%)  6
Rash * 1  4/73 (5.48%)  6
Urticaria * 1  4/73 (5.48%)  4
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (14.0)
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB Clinical Trial Call Center
Organization: UCB
Phone: +1 877 822 9493 (UCB)
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB Japan Co. Ltd. )
ClinicalTrials.gov Identifier: NCT01063764     History of Changes
Other Study ID Numbers: N01223
2014-004335-39 ( EudraCT Number )
First Submitted: February 1, 2010
First Posted: February 5, 2010
Results First Submitted: March 28, 2012
Results First Posted: June 19, 2012
Last Update Posted: March 5, 2015