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A Study of Levetiracetam in Japanese Pediatric Patients With Generalized Tonic-clonic Seizures

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ClinicalTrials.gov Identifier: NCT01292837
Recruitment Status : Completed
First Posted : February 10, 2011
Results First Posted : August 12, 2014
Last Update Posted : May 15, 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
Generalized Tonic-clonic Seizures
Intervention Drug: Levetiracetam
Enrollment 13
Recruitment Details

This multicenter study started to enroll subjects in Februray 2011 in order to end up with 8 sites in Japan with enrolled subjects.

Participant Flow refers to the Enrolled Set (ES). ES consists of all subjects who signed the consent form and participated in the Prospective Baseline Period.

Pre-assignment Details  
Arm/Group Title Levetiracetam
Hide Arm/Group Description

Twice daily (morning and evening) orally

Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks.

Period Title: Overall Study
Started 13
Completed 11
Not Completed 2
Reason Not Completed
Adverse Event             1
Further treatment determined             1
Arm/Group Title Levetiracetam
Hide Arm/Group Description

Twice daily (morning and evening) orally

Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks.

Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
The Baseline Analysis Population refers to the Safety Set. The Safety Set was a subset of the Enrolled Set and consisted of all subjects taking at least 1 dose of the study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants
9.7  (4.1)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants
≥4 to <8 years 4
≥8 to <12 years 2
≥12 to <16 years 7
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
4
  30.8%
Male
9
  69.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 13 participants
13
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram
Number Analyzed 13 participants
32.22  (16.56)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeter
Number Analyzed 13 participants
129.36  (26.32)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kilogram per squaremeter (kg/m^2)
Number Analyzed 13 participants
17.89  (3.75)
1.Primary Outcome
Title The Percent Change From the Combined Baseline (4-week Retrospective Baseline and 4-week Prospective Baseline) in the Generalized Tonic-clonic Seizure Frequency Per Week Over the 24-week Treatment Period (Up-Titration and Evaluation Periods)
Hide Description

The percent change from Combined Baseline over Treatment Period was calculated from the Generalized Tonic-Clonic (GTC) seizure frequency per week during the Treatment Period (T) and during the Baseline Period (B, Combined Baseline, ie, Retrospective and Prospective Baseline Periods) using the equation below.

The percent change from Baseline = (B - T)/B x 100

The seizure frequency per week was calculated using the following formula:

Frequency per week of GTC seizures = total number of GTC seizures in the corresponding period / number of days for observation in the corresponding period x 7

Time Frame From Baseline (Week -8) to Treatment Period (Week 0 to Week 24)
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Full Analysis Set (FAS). The FAS was a subset of the Safety Set and included all subjects with Combined Baseline Period (Retrospective and Prospective) and post-Baseline Generalized Tonic-Clonic seizure counts as the primary efficacy analysis.
Arm/Group Title Levetiracetam
Hide Arm/Group Description:

Twice daily (morning and evening) orally

Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks.

Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: percent change
45.47  (50.34)
2.Secondary Outcome
Title The Percent Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Period Over the Evaluation Period
Hide Description

The percent change from Combined Baseline over Evaluation Period was calculated from the Generalized Tonic-Clonic (GTC) seizure frequency per week during the Evaluation Period (E) and during the Baseline Period (B, Combined Baseline, ie, Retrospective and Prospective Baseline Periods) using the equation below.

The percent change from Baseline = (B - E)/B x 100

The seizure frequency per week was calculated using the following formula:

Frequency per week of GTC seizures = total number of GTC seizures in the corresponding period / number of days for observation in the corresponding period x 7

Time Frame From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24)
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Full Analysis Set (FAS). The FAS was a subset of the Safety Set and included all subjects with combined Baseline Period and post-Baseline generalized tonic-clonic seizure counts. 12 of the 13 subjects in the FAS were included in the analysis excluding 1 subject discontinued before the Evaluation Period.
Arm/Group Title Levetiracetam
Hide Arm/Group Description:

Twice daily (morning and evening) orally

Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks.

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: percent change
44.93  (51.86)
3.Secondary Outcome
Title Generalized Tonic-clonic Seizures 50 % Responder Rate (the Proportion of Subjects With 50 % or More Reduction From the Combined Baseline in the Frequency of Generalized Tonic-clonic Seizures) During the Treatment Period
Hide Description The 50 % responder rate during the Treatment Period was the proportion of subjects who reported a ≥ 50 % reduction in seizure frequency per week from Baseline during the Treatment Period.
Time Frame From Baseline (Week -8) to Treatment Period (Week 0 to Week 24)
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Full Analysis Set (FAS). The FAS was a subset of the Safety Set and included all subjects with Combined Baseline Period (Retrospective and Prospective) and post-Baseline Generalized Tonic-Clonic seizure counts as the primary efficacy analysis.
Arm/Group Title Levetiracetam
Hide Arm/Group Description:

Twice daily (morning and evening) orally

Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks.

Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: percentage of participants
53.8
4.Secondary Outcome
Title Generalized Tonic-clonic Seizures 50 % Responder Rate During the Evaluation Period
Hide Description The 50 % responder rate during the Evaluation Period was the proportion of subjects who reported a ≥50 % reduction in seizure frequency per week from Baseline during the Evaluation Period.
Time Frame From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24)
Hide Outcome Measure Data
Hide Analysis Population Description

The Analysis Population refers to the Full Analysis Set (FAS). The FAS was a subset of the Safety Set and included all subjects with Combined Baseline Period (Retrospective and Prospective) and post-Baseline Generalized Tonic-Clonic seizure counts as the primary efficacy analysis.

One subject discontinued the study during the Up-Titration Period.

Arm/Group Title Levetiracetam
Hide Arm/Group Description:

Twice daily (morning and evening) orally

Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks.

Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: percentage of participants
58.3
5.Secondary Outcome
Title Generalized Tonic-clonic Seizure Freedom Over the Treatment Period
Hide Description A subject with a generalized tonic-clonic seizure frequency of 0 per week throughout the Treatment Period was considered a seizure-free subject for that period.
Time Frame Treatment Period (Week 0 to Week 24)
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Full Analysis Set (FAS). The FAS was a subset of the Safety Set and included all subjects with Combined Baseline Period (Retrospective and Prospective) and post-Baseline Generalized Tonic-Clonic seizure counts as the primary efficacy analysis.
Arm/Group Title Levetiracetam
Hide Arm/Group Description:

Twice daily (morning and evening) orally

Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks.

Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: participants
2
6.Secondary Outcome
Title Generalized Tonic-clonic Seizure Freedom Over the Evaluation Period
Hide Description A subject with a generalized tonic-clonic seizure frequency of 0 per week throughout the Evaluation Period was considered a seizure-free subject for that period.
Time Frame Evaluation Period (Week 4 to Week 24)
Hide Outcome Measure Data
Hide Analysis Population Description

The Analysis Population refers to the Full Analysis Set (FAS). The FAS was a subset of the Safety Set and included all subjects with Combined Baseline Period (Retrospective and Prospective) and post-Baseline Generalized Tonic-Clonic seizure counts as the primary efficacy analysis.

One subject discontinued the study during the Up-Titration Period.

Arm/Group Title Levetiracetam
Hide Arm/Group Description:

Twice daily (morning and evening) orally

Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks.

Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: participants
2
Time Frame Treatment Emergent Adverse Events were reported from Baseline up to Week 30
Adverse Event Reporting Description The Analysis Population refers to the Safety Set. The Safety Set was a subset of the Enrolled Set and consisted of all subjects taking at least 1 dose of the study medication.
 
Arm/Group Title Levetiracetam
Hide Arm/Group Description

Twice daily (morning and evening) orally

Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks.

All-Cause Mortality
Levetiracetam
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Levetiracetam
Affected / at Risk (%) # Events
Total   0/13 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Levetiracetam
Affected / at Risk (%) # Events
Total   13/13 (100.00%)    
Gastrointestinal disorders   
Diarrhoea * 1  2/13 (15.38%)  5
Dental caries * 1  1/13 (7.69%)  1
Stomatitis * 1  1/13 (7.69%)  1
General disorders   
Pyrexia * 1  1/13 (7.69%)  2
Infections and infestations   
Nasopharyngitis * 1  3/13 (23.08%)  5
Impetigo * 1  1/13 (7.69%)  1
Otitis media * 1  1/13 (7.69%)  1
Pneumonia mycoplasmal * 1  1/13 (7.69%)  1
Injury, poisoning and procedural complications   
Arthropod sting * 1  1/13 (7.69%)  1
Contusion * 1  1/13 (7.69%)  1
Laceration * 1  1/13 (7.69%)  1
Subcutaneous haematoma * 1  1/13 (7.69%)  1
Investigations   
Electrocardiogram QT prolonged * 1  1/13 (7.69%)  1
Metabolism and nutrition disorders   
Decreased appetite * 1  1/13 (7.69%)  1
Musculoskeletal and connective tissue disorders   
Pain in extremity * 1  1/13 (7.69%)  1
Nervous system disorders   
Convulsion * 1  3/13 (23.08%)  5
Somnolence * 1  3/13 (23.08%)  3
Bradykinesia * 1  1/13 (7.69%)  1
Headache * 1  1/13 (7.69%)  1
Respiratory, thoracic and mediastinal disorders   
Epistaxis * 1  1/13 (7.69%)  1
Respiratory tract haemorrhage * 1  1/13 (7.69%)  2
Rhinitis allergic * 1  1/13 (7.69%)  1
Skin and subcutaneous tissue disorders   
Dermatitis * 1  1/13 (7.69%)  1
Excessive granulation tissue * 1  1/13 (7.69%)  1
Rash * 1  1/13 (7.69%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.0
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
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB Japan Co. Ltd. )
ClinicalTrials.gov Identifier: NCT01292837     History of Changes
Other Study ID Numbers: N01363
2014-004382-25 ( EudraCT Number )
First Submitted: February 8, 2011
First Posted: February 10, 2011
Results First Submitted: June 3, 2014
Results First Posted: August 12, 2014
Last Update Posted: May 15, 2015