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Community based study assessing safety and efficacy of levetiracetam in partial onset seizures.
The optimal dose in daily clinical practice will be used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levetiracetam | Experimental | Subjects received open-label Levetiracetam. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levetiracetam | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Adverse Events (AEs) | An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. | From Baseline until Safety visit (two weeks after last dose; up to Week 18) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Historical Baseline in Partial (Type I) Seizure Frequency Per Week Over the Treatment Period | Percentage change from baseline in partial (Type I) seizure frequency over the treatment period standardized to 1 week period. Type I Partial (focal, local) seizure frequency per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 1 week period. A negative value in percent change from historical baseline indicates a decrease in partial (type I) seizure frequency from historical baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | UCB (+1 844 599 2273) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| N01036 808 | Hong Kong | Hong Kong | ||||
| N01036 842 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20462804 | Result | Kwan P, Lim SH, Chinvarun Y, Cabral-Lim L, Aziz ZA, Lo YK, Tonner F, Beh K, Edrich P; N01036 (SKATE II) Investigator Group. Efficacy and safety of levetiracetam as adjunctive therapy in adult patients with uncontrolled partial epilepsy: the Asia SKATE II Study. Epilepsy Behav. 2010 May;18(1-2):100-5. doi: 10.1016/j.yebeh.2010.03.016. Epub 2010 May 11. |
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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Participant Flow refers to the Intend-to-treat (ITT) Set.
The study started to enroll patients in November 2003 and concluded in May 2006.
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| ID | Title | Description |
|---|---|---|
| FG000 | Levetiracetam | Subjects received open-label Levetiracetam. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Week 16, compared to Baseline |
| Percentage Change From Historical Baseline in Total (Type I+II+III) Seizure Frequency Per Week Over the Treatment Period | Percentage change from baseline in total (type I+II+III) seizure frequency over the treatment period standardized to 1 week period. Types I+II+III seizure frequency (Type I: Partial (focal, local), Type II: Generalized (convulsive or non-convulsive), Type III: Unclassified) per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 1 week period. A negative value in percent change from historical baseline indicates a decrease in total (type I+II+III) seizure frequency from historical baseline. | Week 16, compared to Baseline |
| Percentage of Participants With 50% Response in Seizure Frequency Per Week at Week 16 | 50% response in seizure frequency per Week is defined as >=50% reduction in seizure frequency from Baseline. Types I+II+III seizure frequency (Type I: Partial (focal, local), Type II: Generalized (convulsive or non-convulsive), Type III: Unclassified) per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 1 week period. | Week 16, compared to Baseline |
| Percentage of Participants With 100% Response in Seizure Frequency Per Week at Week 16 | 100% response in seizure frequency per Week is defined as 100% reduction in seizure frequency from Baseline. Types I+II+III seizure frequency (Type I: Partial (focal, local), Type II: Generalized (convulsive or non-convulsive), Type III: Unclassified) per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 1 week period. | Week 16, compared to Baseline |
| Percentage of Patients With Categorized Change From Baseline in Severity of Illness | The overall change in the severity of the subject's illness, compared to the subject's condition prior to the levetiracetam intake, was assessed by the Investigator using Investigator's Global Evaluation Scale (IGS). Categories are as following: Marked improvement; Moderate improvement; Slight improvement; No change; Slight worsening; Moderate worsening; Marked worsening. | Baseline, Week 16 |
| Retention Rate at Week 16 | Retention rate, defined as the number of subjects who were still on levetiracetam at Visit 5 (Week 16) or on the day before divided by the number of subjects in the ITT population. | Week 16 |
| Hong Kong |
| Hong Kong |
| N01036 815 | Kwun Tong | Hong Kong |
| N01036 811 | Kuala Lumpur | Malaysia |
| N01036 812 | Kuala Lumpur | Malaysia |
| N01036 813 | Kuala Lumpur | Malaysia |
| N01036 830 | Manila | Philippines |
| N01036 831 | Manila | Philippines |
| N01036 829 | Quezon | Philippines |
| N01036 804 | Singapore | Singapore |
| N01036 806 | Singapore | Singapore |
| N01036 807 | Singapore | Singapore |
| N01036 828 | Changhua | Taiwan |
| N01036 827 | Hualien City | Taiwan |
| N01036 825 | Kaohsiung City | Taiwan |
| N01036 834 | Kaohsiung City | Taiwan |
| N01036 835 | Kaohsiung City | Taiwan |
| N01036 817 | Taichung | Taiwan |
| N01036 823 | Taichung | Taiwan |
| N01036 818 | Tainan | Taiwan |
| N01036 819 | Taipei | Taiwan |
| N01036 820 | Taipei | Taiwan |
| N01036 821 | Taipei | Taiwan |
| N01036 822 | Taoyuan | Taiwan |
| N01036 809 | Bangkok | Thailand |
| N01036 840 | Bangkok | Thailand |
| N01036 841 | Bangkok | Thailand |
| N01036 839 | Chiang Mai | Thailand |
| N01036 810 | Khon Kaen | Thailand |
| COMPLETED |
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| NOT COMPLETED |
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Baseline characteristics refer to the Intend-to-treat (ITT) Set.
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| ID | Title | Description |
|---|---|---|
| BG000 | Levetiracetam | Subjects received open-label Levetiracetam. |
| 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 |
| ||||||||||||||||||||
| 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 | Number of Patients With Adverse Events (AEs) | An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. | Posted | Number | Participants | From Baseline until Safety visit (two weeks after last dose; up to Week 18) |
|
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| |||||||||||||||||||||||||||
| Secondary | Percentage Change From Historical Baseline in Partial (Type I) Seizure Frequency Per Week Over the Treatment Period | Percentage change from baseline in partial (Type I) seizure frequency over the treatment period standardized to 1 week period. Type I Partial (focal, local) seizure frequency per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 1 week period. A negative value in percent change from historical baseline indicates a decrease in partial (type I) seizure frequency from historical baseline. | Only subjects with partial (Type I) seizure frequency per week at baseline >= 0 and non-missing values on treatment period are included in the analysis. Subjects withdrawing from the study are included up to their early discontinuation visit. | Posted | Median | Inter-Quartile Range | percentage changes | Week 16, compared to Baseline |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage Change From Historical Baseline in Total (Type I+II+III) Seizure Frequency Per Week Over the Treatment Period | Percentage change from baseline in total (type I+II+III) seizure frequency over the treatment period standardized to 1 week period. Types I+II+III seizure frequency (Type I: Partial (focal, local), Type II: Generalized (convulsive or non-convulsive), Type III: Unclassified) per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 1 week period. A negative value in percent change from historical baseline indicates a decrease in total (type I+II+III) seizure frequency from historical baseline. | Only subjects with total (Type I+II+III) seizure frequency per week at baseline >= 0 and non-missing values on treatment period are included in the analysis. Subjects withdrawing from the study are included up to their early discontinuation visit. | Posted | Median | Inter-Quartile Range | percentage changes | Week 16, compared to Baseline |
|
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| Secondary | Percentage of Participants With 50% Response in Seizure Frequency Per Week at Week 16 | 50% response in seizure frequency per Week is defined as >=50% reduction in seizure frequency from Baseline. Types I+II+III seizure frequency (Type I: Partial (focal, local), Type II: Generalized (convulsive or non-convulsive), Type III: Unclassified) per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 1 week period. | Only subjects with seizure frequency per week at baseline >= 0 and non-missing values on treatment period are taken into account for the responder rates. By convention, subjects with frequency per week at baseline equal to zero were considered as non-responder. | Posted | Number | percentage of participants | Week 16, compared to Baseline |
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| Secondary | Percentage of Participants With 100% Response in Seizure Frequency Per Week at Week 16 | 100% response in seizure frequency per Week is defined as 100% reduction in seizure frequency from Baseline. Types I+II+III seizure frequency (Type I: Partial (focal, local), Type II: Generalized (convulsive or non-convulsive), Type III: Unclassified) per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 1 week period. | Only subjects with seizure frequency per week at baseline >= 0 and non-missing values on treatment period are taken into account for the responder rates. By convention, subjects with frequency per week at baseline equal to zero were considered as non-responder. | Posted | Number | percentage of participants | Week 16, compared to Baseline |
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| Secondary | Percentage of Patients With Categorized Change From Baseline in Severity of Illness | The overall change in the severity of the subject's illness, compared to the subject's condition prior to the levetiracetam intake, was assessed by the Investigator using Investigator's Global Evaluation Scale (IGS). Categories are as following: Marked improvement; Moderate improvement; Slight improvement; No change; Slight worsening; Moderate worsening; Marked worsening. | Posted | Number | percentage of participants | Baseline, Week 16 |
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| Secondary | Retention Rate at Week 16 | Retention rate, defined as the number of subjects who were still on levetiracetam at Visit 5 (Week 16) or on the day before divided by the number of subjects in the ITT population. | Posted | Number | percentage of participants | Week 16 |
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Adverse events were collected from Visit 2 (week 2) until Safety Visit (up to 2 weeks after the last dose, up to 16 weeks).
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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 | Subjects received open-label Levetiracetam. | 15 | 251 | 136 | 251 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bicytopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
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| Adverse drug reaction | General disorders | MedDRA | Non-systematic Assessment |
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| Dengue fever | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Thermal burn | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Coordination abnormal | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Depressed level of consciousness | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Grand mal convulsion | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Aggression | Psychiatric disorders | MedDRA | Non-systematic Assessment |
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| Anger | Psychiatric disorders | MedDRA | Non-systematic Assessment |
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| Hallucination, auditory | Psychiatric disorders | MedDRA | Non-systematic Assessment |
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| Suicide attempt | Psychiatric disorders | MedDRA | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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| Stevens-Johnson syndrome | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Sedation | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | +1844 599 | 2273 | UCBCares@ucb.com |
| ID | Term |
|---|---|
| D004828 | Epilepsies, Partial |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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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