Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004382-25 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the efficacy and safety of Levetiracetam dry syrup at doses up to 60 mg/kg/day or 3000 mg/day used as adjunctive therapy in Japanese pediatric patients aged ≥4 to <16 years with uncontrolled Generalized Tonic-Clonic (GTC) seizures despite treatment with 1 or 2 Anti-Epileptic Drugs (AEDs).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levetiracetam | Experimental | Twice daily (morning and evening) orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levetiracetam | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 | From Baseline (Week -8) to Treatment Period (Week 0 to Week 24) |
| Measure | Description | Time Frame |
|---|---|---|
| The Percent Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Period Over the Evaluation Period | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 191 | Akita | Japan | ||||
| 184 |
Not provided
| Label | URL |
|---|---|
| FDA safety Alerts and Recalls | View source |
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Levetiracetam | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24) |
| 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 | 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. | From Baseline (Week -8) to Treatment Period (Week 0 to Week 24) |
| Generalized Tonic-clonic Seizures 50 % Responder Rate During the Evaluation Period | 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. | From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24) |
| Generalized Tonic-clonic Seizure Freedom Over the Treatment Period | 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. | Treatment Period (Week 0 to Week 24) |
| Generalized Tonic-clonic Seizure Freedom Over the Evaluation Period | 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. | Evaluation Period (Week 4 to Week 24) |
| Bunkyō City |
| Japan |
| 309 | Bunkyō City | Japan |
| 107 | Gifu | Japan |
| 303 | Hiroshima | Japan |
| 108 | Kobe | Japan |
| 302 | Kodaira | Japan |
| 306 | Kōshi | Japan |
| 136 | Moriyama | Japan |
| 305 | Nagoya | Japan |
| 190 | Nerima City | Japan |
| 125 | Neyagawa | Japan |
| 301 | Niigata | Japan |
| 116 | Ohmura | Japan |
| 109 | Okayama | Japan |
| 308 | Ōnojō | Japan |
| 119 | Saitama | Japan |
| 117 | Sapporo | Japan |
| 304 | Sapporo | Japan |
| 103 | Sendai | Japan |
| 138 | Shimotsuke | Japan |
| 307 | Shizuoka | Japan |
| 139 | Takatsuki | Japan |
| 135 | Tsu | Japan |
| 193 | Yokohama | Japan |
| 310 | Yufu | Japan |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Levetiracetam | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Age, Customized | Number | participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Weight | Mean | Standard Deviation | kilogram |
| ||||||||||||||||||||||
| Height | Mean | Standard Deviation | centimeter |
| ||||||||||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kilogram per squaremeter (kg/m^2) |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | 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 | 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. | Posted | Mean | Standard Deviation | percent change | From Baseline (Week -8) to Treatment Period (Week 0 to Week 24) |
|
|
| |||||||||||||||||||||||||
| Secondary | The Percent Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Period Over the Evaluation Period | 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 | 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. | Posted | Mean | Standard Deviation | percent change | From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24) |
| |||||||||||||||||||||||||||
| Secondary | 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 | 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. | 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. | Posted | Number | percentage of participants | From Baseline (Week -8) to Treatment Period (Week 0 to Week 24) |
|
| |||||||||||||||||||||||||||
| Secondary | Generalized Tonic-clonic Seizures 50 % Responder Rate During the Evaluation Period | 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. | 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. | Posted | Number | percentage of participants | From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24) |
|
| |||||||||||||||||||||||||||
| Secondary | Generalized Tonic-clonic Seizure Freedom Over the Treatment Period | 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. | 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. | Posted | Number | participants | Treatment Period (Week 0 to Week 24) |
|
| |||||||||||||||||||||||||||
| Secondary | Generalized Tonic-clonic Seizure Freedom Over the Evaluation Period | 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. | 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. | Posted | Number | participants | Evaluation Period (Week 4 to Week 24) |
|
|
Treatment Emergent Adverse Events were reported from Baseline up to Week 30
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Levetiracetam | 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. | 0 | 13 | 13 | 13 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pneumonia mycoplasmal | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Subcutaneous haematoma | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Bradykinesia | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Respiratory tract haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Excessive granulation tissue | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB Clinical Trial Call Center | UCB | ++1 877 822 9493 |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| ≥12 to <16 years |
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
|