Trial Outcomes & Findings for Open-label Study to Evaluate the Safety and Tolerability of iv Lacosamide in Japanese Adults With Partial-onset Seizures (NCT NCT02192814)
NCT ID: NCT02192814
Last Updated: 2017-08-25
Results Overview
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.
COMPLETED
PHASE3
9 participants
During the study (Screening through End of Study (Day -1 through Day 6))
2017-08-25
Participant Flow
This multicenter, open-label study started recruiting in June 2014.
Participant Flow refers to the Safety Set (SS), consisting of all enrolled subjects who received at least 1 infusion of iv LCM.
Participant milestones
| Measure |
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).
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Overall Study
STARTED
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9
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Overall Study
COMPLETED
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9
|
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Open-label Study to Evaluate the Safety and Tolerability of iv Lacosamide in Japanese Adults With Partial-onset Seizures
Baseline characteristics by cohort
| Measure |
Lacosamide (LCM)
n=9 Participants
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).
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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9 Participants
n=5 Participants
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
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Age, Continuous
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26.9 years
STANDARD_DEVIATION 10.0 • n=5 Participants
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Sex: Female, Male
Female
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5 Participants
n=5 Participants
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Sex: Female, Male
Male
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4 Participants
n=5 Participants
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Weight
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55.99 kilogram (kg)
STANDARD_DEVIATION 13.13 • n=5 Participants
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Height
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159.07 centimeter (cm)
STANDARD_DEVIATION 8.63 • n=5 Participants
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PRIMARY outcome
Timeframe: During the study (Screening through End of Study (Day -1 through Day 6))Population: The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.
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.
Outcome measures
| Measure |
Lacosamide (LCM)
n=9 Participants
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).
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The Total Number of Subjects Experiencing at Least One Adverse Event During the Study
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4 participants
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PRIMARY outcome
Timeframe: During the study (Screening through End of Study (Day -1 through Day 6))Population: The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.
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.
Outcome measures
| Measure |
Lacosamide (LCM)
n=9 Participants
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).
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|---|---|
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The Total Number of Subject Withdrawal Due to Adverse Events During the Study
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0 participants
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SECONDARY outcome
Timeframe: 20 minutes prior infusion at Day 1Population: The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.
Outcome measures
| Measure |
Lacosamide (LCM)
n=9 Participants
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).
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Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 1
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4.738 µg/mL
Geometric Coefficient of Variation 50.5
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SECONDARY outcome
Timeframe: 20 minutes prior infusion at Day 2Population: The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.
Outcome measures
| Measure |
Lacosamide (LCM)
n=9 Participants
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).
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|---|---|
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Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 2
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4.004 µg/mL
Geometric Coefficient of Variation 55.4
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SECONDARY outcome
Timeframe: 20 minutes prior infusion at Day 5Population: The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.
Outcome measures
| Measure |
Lacosamide (LCM)
n=9 Participants
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).
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|---|---|
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Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 5
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3.615 µg/mL
Geometric Coefficient of Variation 60.0
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SECONDARY outcome
Timeframe: 20 minutes prior infusion at Day 1Population: The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.
Outcome measures
| Measure |
Lacosamide (LCM)
n=9 Participants
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).
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|---|---|
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Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 1
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10.838 µg/mL
Geometric Coefficient of Variation 46.6
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SECONDARY outcome
Timeframe: 20 minutes prior infusion at Day 2Population: The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.
Outcome measures
| Measure |
Lacosamide (LCM)
n=9 Participants
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).
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|---|---|
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Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 2
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10.330 µg/mL
Geometric Coefficient of Variation 50.0
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SECONDARY outcome
Timeframe: 20 minutes prior infusion at Day 5Population: The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.
Outcome measures
| Measure |
Lacosamide (LCM)
n=9 Participants
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).
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|---|---|
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Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 5
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9.621 µg/mL
Geometric Coefficient of Variation 38.8
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OTHER_PRE_SPECIFIED outcome
Timeframe: From Day -1 to Day 5No descriptive statistics have been calculated for this exploratory Outcome Measure.
Outcome measures
Outcome data not reported
Adverse Events
Lacosamide (LCM)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lacosamide (LCM)
n=9 participants at risk
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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Infections and infestations
Nasopharyngitis
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11.1%
1/9 • Number of events 1 • 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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Gastrointestinal disorders
Abdominal pain upper
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11.1%
1/9 • Number of events 1 • 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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Gastrointestinal disorders
Toothache
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11.1%
1/9 • Number of events 1 • 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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Gastrointestinal disorders
Vomiting
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11.1%
1/9 • Number of events 1 • 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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General disorders
Injection site erythema
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11.1%
1/9 • Number of events 1 • 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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|
General disorders
Injection site pain
|
11.1%
1/9 • Number of events 1 • 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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Injury, poisoning and procedural complications
Procedural headache
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11.1%
1/9 • Number of events 1 • 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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|
Injury, poisoning and procedural complications
Thermal burn
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11.1%
1/9 • Number of events 1 • 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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Additional Information
UCB Clinical Trial Call Center
UCB Pharma
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60