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| ID | Type | Description | Link |
|---|---|---|---|
| EP0024 | Other Identifier | JAPIC |
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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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EP0024 is a Phase 3, multicenter, open-label study to evaluate the safety and tolerability of intravenous (iv) lacosamide (LCM). Adjunctive iv LCM therapy (200 mg/day to 400 mg/day) will be administered for 5 days as replacement for oral LCM tablets in Japanese adults with partial-onset seizures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lacosamide (LCM) | Experimental | On Day - 1, LCM oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply. During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days. The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lacosamide (200 mg/20 mL) | Drug | Active Substance: Lacosamide Pharmaceutical form: Solution for intravenous (iv) infusion Concentration: adapted on concentration of oral dose in EP0009 Route of Administration: Drip infusion |
| Measure | Description | Time Frame |
|---|---|---|
| The Total Number of Subjects Experiencing at Least One Adverse Event During the Study | An Adverse Event (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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | During the study (Screening through End of Study (Day -1 through Day 6)) |
| The Total Number of Subject Withdrawal Due to Adverse Events During the Study | An Adverse Event (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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | During the study (Screening through End of Study (Day -1 through Day 6)) |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 1 | 20 minutes prior infusion at Day 1 | |
| Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 2 | 20 minutes prior infusion at Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| The Cumulative Partial-onset Seizure Frequency From Day -1 to Day 5 | No descriptive statistics have been calculated for this exploratory Outcome Measure. | From Day -1 to Day 5 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | 1-877-822-9493 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 81027 | Hamamatsu | Japan | ||||
| 81024 |
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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), consisting of all enrolled subjects who received at least 1 infusion of iv LCM.
This multicenter, open-label study started recruiting in June 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lacosamide (LCM) | On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply. During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days. The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participant Flow refers to the Safety Set (SS), consisting of all enrolled subjects who received at least 1 infusion of iv LCM.
Subjects participating in EP0009 (NCT01832038) have been enrolled to EP0024.
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| ID | Title | Description |
|---|---|---|
| BG000 | Lacosamide (LCM) | On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply. During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days. The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Total Number of Subjects Experiencing at Least One Adverse Event During the Study | An Adverse Event (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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM. | Posted | Number | participants | During the study (Screening through End of Study (Day -1 through Day 6)) |
|
Adverse Events (AEs) were collected from Screening Period (Day -1) until End-of-Study Period (Day 6).
Adverse Events refer to the Safety Set (SS) which constisted of all all enrolled subjects who received at least 1 infusion of iv LCM.
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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 (LCM) | On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply. During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days. The daily dose of iv LCM was be the same as the subject's current daily dose of oral LCM in EP0009 (200 - 400 mg/day). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB Clinical Trial Call Center | UCB Pharma | +1877 822 | 9493 |
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| 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 |
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|
| Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 5 | 20 minutes prior infusion at Day 5 |
| Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 1 | 20 minutes prior infusion at Day 1 |
| Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 2 | 20 minutes prior infusion at Day 2 |
| Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 5 | 20 minutes prior infusion at Day 5 |
| Kodaira |
| Japan |
| 81025 | Sapporo | Japan |
| 81003 | Shizuoka | Japan |
| 81023 | Suita | Japan |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kilogram (kg) |
|
| Height | Mean | Standard Deviation | centimeter (cm) |
|
|
|
| Primary | The Total Number of Subject Withdrawal Due to Adverse Events During the Study | An Adverse Event (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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM. | Posted | Number | participants | During the study (Screening through End of Study (Day -1 through Day 6)) |
|
|
|
| Secondary | Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 1 | The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | 20 minutes prior infusion at Day 1 |
|
|
|
| Secondary | Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 2 | The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | 20 minutes prior infusion at Day 2 |
|
|
|
| Secondary | Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 5 | The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | 20 minutes prior infusion at Day 5 |
|
|
|
| Secondary | Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 1 | The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | 20 minutes prior infusion at Day 1 |
|
|
|
| Secondary | Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 2 | The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | 20 minutes prior infusion at Day 2 |
|
|
|
| Secondary | Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 5 | The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | 20 minutes prior infusion at Day 5 |
|
|
|
| Other Pre-specified | The Cumulative Partial-onset Seizure Frequency From Day -1 to Day 5 | No descriptive statistics have been calculated for this exploratory Outcome Measure. | Not Posted | From Day -1 to Day 5 | Participants |
| 0 |
| 9 |
| 4 |
| 9 |
| Toothache | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
|
| Procedural headache | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
|
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| Acids, Acyclic |
| D002264 | Carboxylic Acids |