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The investigators will provide Levetiracetam treatment to epilepsy subjects in Japan who are judged to benefit from continued treatment with Levetiracetam by the investigators and who are willing to continuously receive this drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levetiracetam | Experimental | Twice daily (morning and evening) orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levetiracetam | Drug | formulation: tablet or dry syrup strength: 250 mg tablet, 500 mg tablet, dry syrup 50% dosage: Sb ≥16 years and ≥4 and <16 years (≥50 kg): 1000 mg/day, 2000 mg/day or 3000 mg/day; Sb ≥4 and <16 years (<50kg): 20 mg/kg/day, 40 mg/kg/day, or 60 mg/kg/day frequency: twice daily |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment Emergent Adverse Events During the Entire Study Period | Through study completion, an average of 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage Change in Generalized Tonic-Clonic (GTC) Seizure Frequency Per Week Over the Evaluation Period From Either of the Combined Baseline Periods of the Previous Studies (N01159 or N01363). | Percentage change in generalized tonic-clonic (GTC) seizure frequency per week from Baseline of previous studies B over the Treatment Period A is calculated using the equation: Percentage change from Baseline = ((A-B)/B)*100. Percentage change from baseline is not defined for subjects whose baseline information is missing / unknown or equal to zero, or whose seizure frequency per week is missing/unknown. A negative value in change in generalized tonic-clonic (GTC) seizure frequency indicates a reduction of generalized tonic-clonic (GTC) seizure frequency over the Treatment Period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 152 | Fujisawa | Japan | ||||
| 112 |
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| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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Participant Flow refers to the Safety Set (SS) which consisted of all subjects who took at least one dose of study medication in this study.
This study started to enroll subjects in Japan in June 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Levetiracetam | Levetiracetam dose was be adjusted at the investigator's discretion in the range from 20mg/kg/day or 1000mg/day to 60mg/kg/day or 3000mg/day during this study |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| During the Treatment Period (up to 4.8 years) |
| The Incidence of Adverse Drug Reactions During the Entire Study Period | Adverse drug reactions excludes Adverse Events (AEs) described by the investigators with no relationship to study drug. | Through study completion, an average of 3 years |
| Fukuoka |
| Japan |
| 113 | Fukuoka | Japan |
| 165 | Fukuoka | Japan |
| 166 | Fukuoka | Japan |
| 187 | Fukushima | Japan |
| 107 | Gifu | Japan |
| 162 | Himeji | Japan |
| 110 | Hiroshima | Japan |
| 117 | Hokkaido | Japan |
| 130 | Hokkaido | Japan |
| 176 | Hokkaido | Japan |
| 143 | Kagoshima | Japan |
| 156 | Kagoshima | Japan |
| 120 | Kodaira | Japan |
| 105 | Kokubunji | Japan |
| 306 | Kōshi | Japan |
| 172 | Miyazaki | Japan |
| 179 | Miyazaki | Japan |
| 305 | Nagoya | Japan |
| 106 | Niigata | Japan |
| 153 | Niigata | Japan |
| 109 | Okayama | Japan |
| 174 | Osaka | Japan |
| 119 | Saitama | Japan |
| 147 | Sakai | Japan |
| 194 | Sakai | Japan |
| 304 | Sapporo | Japan |
| 138 | Tochigi | Japan |
| 184 | Tokyo | Japan |
| 190 | Tokyo | Japan |
| 111 | Ube | Japan |
| COMPLETED |
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| NOT COMPLETED |
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The Baseline Characteristics refer to the Safety Set (SS) which consisted of all subjects who took at least one dose of study medication in this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Levetiracetam | Levetiracetam dose was be adjusted at the investigator's discretion in the range from 20mg/kg/day or 1000mg/day to 60mg/kg/day or 3000mg/day during this study |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Incidence of Treatment Emergent Adverse Events During the Entire Study Period | The Safety Set (SS) consisted of all subjects who took at least one dose of study medication in this study. | Posted | Number | Treatment Emergent Adverse Events | Through study completion, an average of 3 years |
|
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| |||||||||||||||||||||||||||
| Secondary | The Percentage Change in Generalized Tonic-Clonic (GTC) Seizure Frequency Per Week Over the Evaluation Period From Either of the Combined Baseline Periods of the Previous Studies (N01159 or N01363). | Percentage change in generalized tonic-clonic (GTC) seizure frequency per week from Baseline of previous studies B over the Treatment Period A is calculated using the equation: Percentage change from Baseline = ((A-B)/B)*100. Percentage change from baseline is not defined for subjects whose baseline information is missing / unknown or equal to zero, or whose seizure frequency per week is missing/unknown. A negative value in change in generalized tonic-clonic (GTC) seizure frequency indicates a reduction of generalized tonic-clonic (GTC) seizure frequency over the Treatment Period. | The Full Analysis Set (FAS) consisted of all subjects with evaluable baseline and post-baseline values of generalized tonic-clonic (GTC) seizure frequency as the efficacy analysis, excluding those patients who seriously violated Good Clinical Practice (GCP). | Posted | Median | 95% Confidence Interval | percent change | During the Treatment Period (up to 4.8 years) |
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| ||||||||||||||||||||||||||
| Secondary | The Incidence of Adverse Drug Reactions During the Entire Study Period | Adverse drug reactions excludes Adverse Events (AEs) described by the investigators with no relationship to study drug. | The Safety Set (SS) consisted of all subjects who took at least one dose of study medication in this study. | Posted | Number | Adverse Drug Reactions | Through study completion, an average of 3 years |
|
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Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
Advers events refers to the Safety Set (SS) which consisted of all subjects who took at least one dose of study medication in this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Levetiracetam (SS) | Levetiracetam dose was be adjusted at the investigator's discretion in the range from 20mg/kg/day or 1000mg/day to 60mg/kg/day or 3000mg/day during this study | 13 | 44 | 41 | 44 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza | Infections and infestations | MedDRA17.0 | Non-systematic Assessment |
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| Acute tonsillitis | Infections and infestations | MedDRA17.0 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA17.0 | Non-systematic Assessment |
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| Bronchopneumonia | Infections and infestations | MedDRA17.0 | Non-systematic Assessment |
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| Pharyngotonsillitis | Infections and infestations | MedDRA17.0 | Non-systematic Assessment |
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| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA17.0 | Non-systematic Assessment |
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| Postoperative wound infection | Infections and infestations | MedDRA17.0 | Non-systematic Assessment |
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| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA17.0 | Non-systematic Assessment |
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| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA17.0 | Non-systematic Assessment |
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| Medical observation | Investigations | MedDRA17.0 | Non-systematic Assessment |
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| Fracture malunion | Musculoskeletal and connective tissue disorders | MedDRA17.0 | Non-systematic Assessment |
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| Torticollis | Musculoskeletal and connective tissue disorders | MedDRA17.0 | Non-systematic Assessment |
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| Breast adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA17.0 | Non-systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA17.0 | Non-systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDRA17.0 | Non-systematic Assessment |
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| Monoplegia | Nervous system disorders | MedDRA17.0 | Non-systematic Assessment |
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| Prostatitis | Reproductive system and breast disorders | MedDRA17.0 | Non-systematic Assessment |
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| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA17.0 | Non-systematic Assessment |
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| Status asthmaticus | Respiratory, thoracic and mediastinal disorders | MedDRA17.0 | Non-systematic Assessment |
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| Abortion induced | Surgical and medical procedures | MedDRA17.0 | Non-systematic Assessment |
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| Scoliosis surgery | Surgical and medical procedures | MedDRA17.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dental caries | Gastrointestinal disorders | MedDRA17.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA17.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA17.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA17.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA17.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA17.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA17.0 | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA17.0 | Non-systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA17.0 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA17.0 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA17.0 | Non-systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA17.0 | Non-systematic Assessment |
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| Pulpitis dental | Infections and infestations | MedDRA17.0 | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA17.0 | Non-systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | MedDRA17.0 | Non-systematic Assessment |
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| Wound | Injury, poisoning and procedural complications | MedDRA17.0 | Non-systematic Assessment |
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| Weight increased | Investigations | MedDRA17.0 | Non-systematic Assessment |
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| Electrocardiogram QT prolonged | Investigations | MedDRA17.0 | Non-systematic Assessment |
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| Protein urine present | Investigations | MedDRA17.0 | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA17.0 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA17.0 | Non-systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA17.0 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA17.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA17.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA17.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA17.0 | Non-systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA17.0 | Non-systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA17.0 | Non-systematic Assessment |
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| Skin erosion | Skin and subcutaneous tissue disorders | MedDRA17.0 | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB (Study Director) | UCB Cares | +1887822 | 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 |
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| 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 |
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