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This study is to evaluate the long-term safety and tolerability of Lacosamide (LCM) 200 mg/day to LCM 600 mg/day taken in monotherapy in Japanese subjects who currently have partial-onset seizures with or without secondary generalization and who are treated with a single Anti-Epileptic Drug (AED) with marketing approval in Japan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lacosamide | Experimental | Open-label, single-arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lacosamide | Drug | Lacosamide (LCM) immediate-release, film-coated tablets at a strength of 50 mg orally administered twice daily in two equally divided doses.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With at Least One Incidence of Treatment-Emergent Adverse Events (TEAEs) During the Study | An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | From the Titration Period (investigational product is taken) to the End of Study Visit (up to 3.5 years) |
| Number of Subjects Who Withdraw Due to Adverse Events (AEs) During the Study | An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | From the Titration Period (investigational product is taken) to the End of Study Visit (up to 3.5 years) |
| Number of Subjects With at Least One Incidence of Serious Adverse Events (SAEs) During the Study | A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:
| From the Titration Period (investigational product is taken) to the End of Study Visit (up to 3.5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Remaining Seizure Free for 6 Consecutive Months During the Monotherapy Period | Subjects were considered seizure free if their seizure counts for every day over the entire Treatment Period was zero and if they completed the Treatment Period. A subject was considered seizure free, if no seizure occurred during the 6 consecutive months in the Evaluation Period. If one of the following occurred, the subject was not considered seizure free:
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | +1 844 599 2273 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 5 | Asaka | Japan | ||||
| 1 |
Participant flow refers to Safety Set including all subjects which took at least one dose of study medication.
The study started to enroll patients in April 2014 and concluded in November 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lacosamide | Subjects randomized in this arm received lacosamide from 200 mg/day to 600 mg/day, from the Titration to the End of Study Visit (up to 3.5 years). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 9, 2013 | Nov 9, 2018 |
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| From the beginning of the Monotherapy Period to the end of the Follow-Up Period (up to 3.1 years until the time of approval granted) |
| Number of Subjects Remaining Seizure Free for 12 Consecutive Months During the Monotherapy Period | Subjects were considered seizure free if their seizure counts for every day over the entire Treatment Period was zero and if they completed the Treatment Period. A subject was considered seizure free, if no seizure occurred during the 12 consecutive months in the Evaluation Period. If one of the following occurred, the subject was not considered seizure free:
Subjects who discontinued before the end date of 6 consecutive months were included in this analysis. | From the beginning of the Monotherapy Period to the end of the Follow-Up Period (up to 3.1 years until the time of approval granted) |
| Percentage of Participants in the Monotherapy Period Without Discontinuation Due to Adverse Events (AE) or Lack of Efficacy (LOE) | For Time to discontinuation (event), Retention rate and 95% CI was calculated using the Kaplan-Meier method. Retention rate is indicated in Percent and 95% confidence intervals (CI) with respect to the Time to discontinuation. | From the beginning of the Monotherapy Period to the end of the Follow-Up Period (up to 3.1 years until the time of approval granted) |
| Plasma Concentrations of Lacosamide Versus Time Postdose | Dose-normalized lacosamide Plasma Concentration (µg/mL) by Visit and Dose during the Evaluation Period. | From Titration Period up to Week 94 |
| Hamamatsu |
| Japan |
| 11 | Itami | Japan |
| 6 | Kagoshima | Japan |
| 7 | Kamakura | Japan |
| 10 | Nagoya | Japan |
| 12 | Saitama | Japan |
| 8 | Sapporo | Japan |
| 13 | Shinagawa City | Japan |
| 4 | Shizuoka | Japan |
| 9 | Toyonaka | Japan |
| Started Treatment Period |
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| Started Titration Period |
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| Started AED Withdrawal Period |
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| Started Monotherapy Period |
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| Started Evaluation Period |
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| Started Follow-Up Period |
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| COMPLETED |
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| NOT COMPLETED |
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| Taper Period |
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The Baseline Characteristics refer to the Safety Analysis Set which included all subjects who took at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Lacosamide | Subjects randomized in this arm received lacosamide from 200 mg/day to 600 mg/day, from the Titration to the End of Study Visit (up to 3.5 years). |
| 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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| Race/Ethnicity, Customized | 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 Subjects With at Least One Incidence of Treatment-Emergent Adverse Events (TEAEs) During the Study | An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | Posted | Count of Participants | Participants | From the Titration Period (investigational product is taken) to the End of Study Visit (up to 3.5 years) |
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| Primary | Number of Subjects Who Withdraw Due to Adverse Events (AEs) During the Study | An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | Posted | Count of Participants | Participants | From the Titration Period (investigational product is taken) to the End of Study Visit (up to 3.5 years) |
|
| ||||||||||||||||||||||||||||
| Primary | Number of Subjects With at Least One Incidence of Serious Adverse Events (SAEs) During the Study | A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:
| Posted | Count of Participants | Participants | From the Titration Period (investigational product is taken) to the End of Study Visit (up to 3.5 years) |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Subjects Remaining Seizure Free for 6 Consecutive Months During the Monotherapy Period | Subjects were considered seizure free if their seizure counts for every day over the entire Treatment Period was zero and if they completed the Treatment Period. A subject was considered seizure free, if no seizure occurred during the 6 consecutive months in the Evaluation Period. If one of the following occurred, the subject was not considered seizure free:
| The Full Analysis Set (FAS) consisted of subjects in the Safety Set (SS) who had at least 1 seizure diary assessment. Subjects who discontinued before the end date of 6 consecutive months were included in this analysis. | Posted | Count of Participants | Participants | From the beginning of the Monotherapy Period to the end of the Follow-Up Period (up to 3.1 years until the time of approval granted) |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Subjects Remaining Seizure Free for 12 Consecutive Months During the Monotherapy Period | Subjects were considered seizure free if their seizure counts for every day over the entire Treatment Period was zero and if they completed the Treatment Period. A subject was considered seizure free, if no seizure occurred during the 12 consecutive months in the Evaluation Period. If one of the following occurred, the subject was not considered seizure free:
Subjects who discontinued before the end date of 6 consecutive months were included in this analysis. | The Full Analysis Set (FAS) consisted of subjects in the SS who had at least 1 seizure diary assessment. Subjects who discontinued before the end date of 12 consecutive months were included in this Analysis. | Posted | Count of Participants | Participants | From the beginning of the Monotherapy Period to the end of the Follow-Up Period (up to 3.1 years until the time of approval granted) |
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| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants in the Monotherapy Period Without Discontinuation Due to Adverse Events (AE) or Lack of Efficacy (LOE) | For Time to discontinuation (event), Retention rate and 95% CI was calculated using the Kaplan-Meier method. Retention rate is indicated in Percent and 95% confidence intervals (CI) with respect to the Time to discontinuation. | The Full Analysis Set (FAS) consisted of subjects in the Safety Set (SS) who had at least 1 seizure diary assessment. Subjects who discontinued before Monotherapy Period were not included in this Analysis. | Posted | Median | 95% Confidence Interval | Percentage of participant | From the beginning of the Monotherapy Period to the end of the Follow-Up Period (up to 3.1 years until the time of approval granted) |
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| Secondary | Plasma Concentrations of Lacosamide Versus Time Postdose | Dose-normalized lacosamide Plasma Concentration (µg/mL) by Visit and Dose during the Evaluation Period. | Two Subjects withdrew during the AED Withdrawal Period (prior to the Evaluation Period). | Posted | Mean | Standard Deviation | µg/mL | From Titration Period up to Week 94 |
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Adverse Events were collected from Visit 1 until Safety Follow-Up Visit (up to week 2 after last dose), for approximately 3.5 years
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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 | Lacosamide | Subjects randomized in this arm received lacosamide from 200 mg/day to 600 mg/day, from the Titration to the End of Study Visit (up to 3.5 years). | 0 | 19 | 2 | 19 | 19 | 19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Convulsion | Nervous system disorders | 16.1 | Non-systematic Assessment |
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| Varicose vein | Vascular disorders | 16.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | 16.1 | Non-systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | 16.1 | Non-systematic Assessment |
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| Dry eye | Eye disorders | 16.1 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | 16.1 | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | 16.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | 16.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | 16.1 | Non-systematic Assessment |
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| Aphthous stomatitis | Gastrointestinal disorders | 16.1 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | 16.1 | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | 16.1 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | 16.1 | Non-systematic Assessment |
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| Gastritis | Gastrointestinal disorders | 16.1 | Non-systematic Assessment |
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| Gastrointestinal disorder | Gastrointestinal disorders | 16.1 | Non-systematic Assessment |
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| Paraesthesia oral | Gastrointestinal disorders | 16.1 | Non-systematic Assessment |
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| Chest pain | General disorders | 16.1 | Non-systematic Assessment |
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| Irritability | General disorders | 16.1 | Non-systematic Assessment |
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| Malaise | General disorders | 16.1 | Non-systematic Assessment |
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| Pyrexia | General disorders | 16.1 | Non-systematic Assessment |
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| Hepatic steatosis | Hepatobiliary disorders | 16.1 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | 16.1 | Non-systematic Assessment |
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| Influenza | Infections and infestations | 16.1 | Non-systematic Assessment |
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| Acute tonsillitis | Infections and infestations | 16.1 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | 16.1 | Non-systematic Assessment |
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| Cystitis | Infections and infestations | 16.1 | Non-systematic Assessment |
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| Herpes virus infection | Infections and infestations | 16.1 | Non-systematic Assessment |
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| Infected dermal cyst | Infections and infestations | 16.1 | Non-systematic Assessment |
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| Laryngitis | Infections and infestations | 16.1 | Non-systematic Assessment |
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| Periodontitis | Infections and infestations | 16.1 | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | 16.1 | Non-systematic Assessment |
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| Tinea pedis | Infections and infestations | 16.1 | Non-systematic Assessment |
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| Arthropod bite | Injury, poisoning and procedural complications | 16.1 | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | 16.1 | Non-systematic Assessment |
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| Head injury | Injury, poisoning and procedural complications | 16.1 | Non-systematic Assessment |
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| Heat illness | Injury, poisoning and procedural complications | 16.1 | Non-systematic Assessment |
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| Injury | Injury, poisoning and procedural complications | 16.1 | Non-systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | 16.1 | Non-systematic Assessment |
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| Tooth fracture | Injury, poisoning and procedural complications | 16.1 | Non-systematic Assessment |
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| Blood growth hormone increased | Investigations | 16.1 | Non-systematic Assessment |
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| Crystal urine present | Investigations | 16.1 | Non-systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | 16.1 | Non-systematic Assessment |
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| White blood cell count decreased | Investigations | 16.1 | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | 16.1 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | 16.1 | Non-systematic Assessment |
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| Pubic pain | Musculoskeletal and connective tissue disorders | 16.1 | Non-systematic Assessment |
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| Tenosynovitis | Musculoskeletal and connective tissue disorders | 16.1 | Non-systematic Assessment |
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| Fibrous histiocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 16.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | 16.1 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | 16.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | 16.1 | Non-systematic Assessment |
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| Tremor | Nervous system disorders | 16.1 | Non-systematic Assessment |
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| Cerebellar ataxia | Nervous system disorders | 16.1 | Non-systematic Assessment |
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| Complex partial seizures | Nervous system disorders | 16.1 | Non-systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | 16.1 | Non-systematic Assessment |
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| Simple partial seizures | Nervous system disorders | 16.1 | Non-systematic Assessment |
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| Sudden onset of sleep | Nervous system disorders | 16.1 | Non-systematic Assessment |
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| Depressed mood | Psychiatric disorders | 16.1 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | 16.1 | Non-systematic Assessment |
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| Uterine polyp | Reproductive system and breast disorders | 16.1 | Non-systematic Assessment |
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| Vocal cord inflammation | Respiratory, thoracic and mediastinal disorders | 16.1 | Non-systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | 16.1 | Non-systematic Assessment |
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| Chloasma | Skin and subcutaneous tissue disorders | 16.1 | Non-systematic Assessment |
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| Dermatitis allergic | Skin and subcutaneous tissue disorders | 16.1 | Non-systematic Assessment |
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| Eczema asteatotic | Skin and subcutaneous tissue disorders | 16.1 | Non-systematic Assessment |
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| Pustular psoriasis | Skin and subcutaneous tissue disorders | 16.1 | Non-systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | 16.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | +1844599 | 2273 | UCBCares@ucb.comTokyo |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 21, 2016 | Nov 9, 2018 | SAP_001.pdf |
| 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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