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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003622-41 | EudraCT Number | ||
| JapicCTI-121988 | Registry Identifier | JAPIC |
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| Name | Class |
|---|---|
| UCB Japan Co. Ltd. | INDUSTRY |
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The purpose of this study is to evaluate the efficacy and safety of 200 and 400 mg/day of orally administered Lacosamide as adjunctive therapy compared with placebo in Japanese and Chinese adults with uncontrolled Partial-Onset Seizures with or without secondary generalization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Matching placebo for 16 weeks. |
|
| Lacosamide 200 mg/day | Experimental | Lacosamide treatment of 200 mg/day (100 mg bid (twice daily)) for 16 weeks. |
|
| Lacosamide 400 mg/day | Experimental | Lacosamide treatment of 400 mg/day (200 mg bid (twice daily)) for 16 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lacosamide 50 mg | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period | Partial-onset seizure (POS) frequency per 28 days was calculated as: POS frequency = (Number of POS over the specified time interval) / (Number of days in the interval with available diary data) x 28. A negative value in Change in Partial-onset seizure frequency indicates a reduction of Partial-onset seizure frequency from Baseline to the Maintenance Period. | 8-week Baseline Period (Visit 1 to 3) and 12-week Maintenance Period (Visit 5 to 8) |
| Measure | Description | Time Frame |
|---|---|---|
| The Proportion of Individual Patients Who Experience a 50 % or Greater Reduction in Seizure Frequency From Baseline to the Maintenance Period (50 % Responder Rate) | 8-week Baseline Period (Visit 1 to 3) to the 12-week Maintenance Period (Visit 5 to 8) | |
| Percent Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance 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 |
|---|---|---|---|---|---|---|
| 86026 | Beijing | China | ||||
| 86027 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23859801 | Result | Doty P, Hebert D, Mathy FX, Byrnes W, Zackheim J, Simontacchi K. Development of lacosamide for the treatment of partial-onset seizures. Ann N Y Acad Sci. 2013 Jul;1291(1):56-68. doi: 10.1111/nyas.12213. |
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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Overall, 692 subjects were screened and 548 subjects were enrolled. The Participant Flow refers to the Safety Set (SS) which was defined as all enrolled subjects who took at least 1 dose of Lacosamide. Reasons for discontinuation were only calculated for the SS. 547 subjects were included in the Safety Set.
A total of 676 subjects with uncontrolled partial-onset seizures (of the 676 subjects, the number of Chinese subjects and Japanese subjects was planned to be 507 and 169, respectively) was planned to be screened and 540 subjects were planned to be enrolled in all regions of Japan and China.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Matching Placebo for 16 weeks. Placebo: Matching oral Placebo tablets twice daily for 16 weeks. |
| FG001 | Lacosamide 200 mg/Day | Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks. Lacosamide 50 mg: - Active Substance: Lacosamide
Lacosamide 100 mg: - Active Substance: Lacosamide
|
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Lacosamide 100 mg | Drug |
|
|
|
| Placebo | Drug | Matching oral Placebo tablets twice daily for 16 weeks. |
|
Calculates as 28-day seizure frequency during the Maintenance Period - 28-day seizure frequency during the Baseline Period, divided by the 28-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in Partial-Onset Seizure frequency from Baseline to the Maintenance Period. |
| 8-week Baseline Period (Visit 1 to 3) to the 12-week Maintenance Period (Visit 5 to 8) |
| Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Treatment Period (i.e., Titration + Maintenance Period) | Partial-onset seizure (POS) frequency per 28 days was calculated as: POS frequency = (Number of POS over the specified time interval) / (Number of days in the interval with available diary data) x 28. A negative value in Change in Partial-onset seizure frequency indicates a reduction of Partial-onset seizure frequency from Baseline to the Treatment Period. | 8-week Baseline Period (Visit 1 to 3) to the 16-week Treatment Period (Visit 3 to 8) |
| Beijing |
| China |
| 86015 | Changchun | China |
| 86005 | Chengdu | China |
| 86032 | Chengdu | China |
| 86006 | Chongqing | China |
| 86031 | Dalian | China |
| 86009 | Guanghzou | China |
| 86007 | Guangzhou | China |
| 86008 | Guangzhou | China |
| 86013 | Guangzhou | China |
| 86016 | Guangzhou | China |
| 86014 | Hangzhou | China |
| 86010 | Harbin | China |
| 86019 | Jinan | China |
| 86004 | Kunming | China |
| 86011 | Nanchang | China |
| 86012 | Nanchang | China |
| 86028 | Nanjing | China |
| 86003 | Qingdao | China |
| 86001 | Shanghai | China |
| 86023 | Shanghai | China |
| 86025 | Shanghai | China |
| 86021 | Shenyang | China |
| 86020 | Shijiazhuang | China |
| 86022 | Suzhou | China |
| 86002 | Taiyuan | China |
| 86018 | Wuhan | China |
| 86024 | Wuhan | China |
| 86017 | Xi'an | China |
| 86029 | Xiamen | China |
| 81056 | Asaka | Japan |
| 81030 | Fujisawa | Japan |
| 81013 | Fukuoka | Japan |
| 81054 | Fukuoka | Japan |
| 81057 | Hachinohe | Japan |
| 81008 | Hakodate | Japan |
| 81027 | Hamamatsu | Japan |
| 81004 | Himeji | Japan |
| 81018 | Hiroshima | Japan |
| 81019 | Iwanuma | Japan |
| 81012 | Kagoshima | Japan |
| 81033 | Kitakyushu | Japan |
| 81017 | Kobe | Japan |
| 81024 | Kodaira | Japan |
| 81010 | Kokubunji | Japan |
| 81032 | Kōshi | Japan |
| 81014 | Kurume | Japan |
| 81047 | Kyoto | Japan |
| 81035 | Nagakute | Japan |
| 81028 | Nagoya | Japan |
| 81029 | Nagoya | Japan |
| 81040 | Nara | Japan |
| 81007 | Neyagawa | Japan |
| 81002 | Niigata | Japan |
| 81046 | Ohmura | Japan |
| 81005 | Okayama | Japan |
| 81011 | Saitama | Japan |
| 81042 | Sakai | Japan |
| 81025 | Sapporo | Japan |
| 81048 | Sapporo | Japan |
| 81053 | Sapporo | Japan |
| 81009 | Sayama | Japan |
| 81020 | Sendai | Japan |
| 81031 | Sendai | Japan |
| 81021 | Shimotsuke | Japan |
| 81022 | Shimotsuke | Japan |
| 81026 | Shinjuku | Japan |
| 81003 | Shizuoka | Japan |
| 81023 | Suita | Japan |
| 81051 | Suita | Japan |
| 81052 | Suita | Japan |
| 81016 | Takatsuki | Japan |
| 81006 | Toyonaka | Japan |
| 81050 | Ube | Japan |
| 81001 | Yamagata | Japan |
| FG002 | Lacosamide 400 mg/Day | Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks. Lacosamide 50 mg: - Active Substance: Lacosamide
Lacosamide 100 mg: - Active Substance: Lacosamide
|
| Titration Period (4 Weeks) |
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| Maintenance Period (12 Weeks) |
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| COMPLETED |
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| NOT COMPLETED |
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The Baseline Characteristics refer to the Safety Set (SS) which was defined as all enrolled subjects who took at least 1 dose of Lacosamide.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Matching Placebo for 16 weeks. Placebo: Matching oral Placebo tablets twice daily for 16 weeks. |
| BG001 | Lacosamide 200 mg/Day | Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks. Lacosamide 50 mg: - Active Substance: Lacosamide
Lacosamide 100 mg: - Active Substance: Lacosamide
|
| BG002 | Lacosamide 400 mg/Day | Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks. Lacosamide 50 mg: - Active Substance: Lacosamide
Lacosamide 100 mg: - Active Substance: Lacosamide
|
| BG003 | Total | Total of all reporting groups |
| 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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| Race (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | 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 | Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period | Partial-onset seizure (POS) frequency per 28 days was calculated as: POS frequency = (Number of POS over the specified time interval) / (Number of days in the interval with available diary data) x 28. A negative value in Change in Partial-onset seizure frequency indicates a reduction of Partial-onset seizure frequency from Baseline to the Maintenance Period. | The Full Analysis Set consists of all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment. | Posted | Median | Full Range | Seizures per 28 days | 8-week Baseline Period (Visit 1 to 3) and 12-week Maintenance Period (Visit 5 to 8) |
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| Secondary | The Proportion of Individual Patients Who Experience a 50 % or Greater Reduction in Seizure Frequency From Baseline to the Maintenance Period (50 % Responder Rate) | The Full Analysis Set consists of all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment. | Posted | Number | participants | 8-week Baseline Period (Visit 1 to 3) to the 12-week Maintenance Period (Visit 5 to 8) |
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| Secondary | Percent Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period | Calculates as 28-day seizure frequency during the Maintenance Period - 28-day seizure frequency during the Baseline Period, divided by the 28-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in Partial-Onset Seizure frequency from Baseline to the Maintenance Period. | The Full Analysis Set consists of all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment. | Posted | Median | Full Range | percentage change | 8-week Baseline Period (Visit 1 to 3) to the 12-week Maintenance Period (Visit 5 to 8) |
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| Secondary | Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Treatment Period (i.e., Titration + Maintenance Period) | Partial-onset seizure (POS) frequency per 28 days was calculated as: POS frequency = (Number of POS over the specified time interval) / (Number of days in the interval with available diary data) x 28. A negative value in Change in Partial-onset seizure frequency indicates a reduction of Partial-onset seizure frequency from Baseline to the Treatment Period. | The Full Analysis Set consists of all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment. | Posted | Median | Full Range | Seizures per 28 days | 8-week Baseline Period (Visit 1 to 3) to the 16-week Treatment Period (Visit 3 to 8) |
|
Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19).
Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.
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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 | Placebo | Matching Placebo for 16 weeks. Placebo: Matching oral Placebo tablets twice daily for 16 weeks. | 4 | 184 | 77 | 184 | ||
| EG001 | Lacosamide 200 mg/Day | Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks. Lacosamide 50 mg: - Active Substance: Lacosamide
Lacosamide 100 mg: - Active Substance: Lacosamide
| 2 | 183 | 87 | 183 | ||
| EG002 | Lacosamide 400 mg/Day | Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks. Lacosamide 50 mg: - Active Substance: Lacosamide
Lacosamide 100 mg: - Active Substance: Lacosamide
| 9 | 180 | 112 | 180 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Comminuted fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
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| Hand fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
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| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Epileptic psychosis | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Abortion induced | Surgical and medical procedures | MedDRA 16.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diplopia | Eye disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB Clinical Trial Call Center | UCB | +1 877 822 9493 (UCB) |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000078334 | Lacosamide |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| Between 18 and 65 years |
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| >=65 years |
|
| Male |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
|
| Japanese |
|
| Superiority or Other |
| To avoid inflation of Type I error, hypothesis testing followed predefined hierarchical procedure starting LCM 400 mg/day treatment group versus the placebo group. If the test was not statistically significant, the procedure stopped and no Groups were declared different from placebo. If the test was statistically significant, the treatment group was considered different from placebo and the procedure continued with the LCM 200 mg/day treatment group. | ANCOVA | < 0.001 | Significant at the 0.05 level. This testing procedure is considered a closed testing procedure and no adjustment of the significance level was necessary. | % Reduction over Placebo | 29.4 | 2-Sided | 95 | 18.7 | 38.7 | Superiority or Other |
|
|
| Lacosamide 400 mg/Day |
Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks. Lacosamide 50 mg: - Active Substance: Lacosamide
Lacosamide 100 mg: - Active Substance: Lacosamide
|
|
|
| Lacosamide 400 mg/Day |
Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks. Lacosamide 50 mg: - Active Substance: Lacosamide
Lacosamide 100 mg: - Active Substance: Lacosamide
|
|
|