Trial Outcomes & Findings for Study to Investigate Safety and Tolerability of Intravenous Lacosamide in Children. (NCT NCT02710890)
NCT ID: NCT02710890
Last Updated: 2023-02-23
Results Overview
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participant 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. 26 adverse events are reported splitting into at least 19 occurrences of individual pre-treatment emergent adverse events and 7 treatment emergent adverse events (TEAEs).
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
103 participants
Primary outcome timeframe
From Screening Period (Day -7 to Day -1) up to the End-of-Study Period (up to Day 37)
Results posted on
2023-02-23
Participant Flow
The study started to enroll participants in May 2017 and concluded in June 2019.
Participant Flow refers to the Safety Set iv (SS-iv).
Participant milestones
| Measure |
Lacosamide Age Cohort ≥ 1 Month - < 8 Years
This arm consisted of participants who formed Cohort 2, were greater than or equal to (≥) 1 month to less than (\<) 8 years of age and received at least 1 dose of intravenous (iv) lacosamide (LCM). For the first 20 participants in Cohort 2, iv LCM has been infused over a duration of 30 minutes but no longer than 60 minutes whenever possible. After completion of the first 20 participants in Cohort 2, a Data Monitoring Committee (DMC) reviewed the safety and tolerability data for this Cohort and made the following recommendations: the progression of the current Cohort, including iv infusion durations to be evaluated.
|
Lacosamide Age Cohort ≥ 8 - < 17 Years
This arm consisted of participants who formed Cohort 1, were ≥ 8 to \< 17 years of age and received at least 1 dose of iv LCM. For the first 20 participants in Cohort 1, iv LCM has been infused over a duration of 30 minutes but no longer than 60 minutes whenever possible. After completion of the first 20 participants in Cohort 1, a DMC reviewed the safety and tolerability data for this Cohort and made the following recommendations: the progression of the current Cohort, including iv infusion durations to be evaluated, and progression to initiate enrollment in the next Cohort (Cohort 2).
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
55
|
|
Overall Study
COMPLETED
|
48
|
55
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Investigate Safety and Tolerability of Intravenous Lacosamide in Children.
Baseline characteristics by cohort
| Measure |
Lacosamide Age Cohort ≥ 1 Month - < 8 Years
n=48 Participants
This arm consisted of participants who formed Cohort 2, were greater than or equal to (≥) 1 month to less than (\<) 8 years of age and received at least 1 dose of intravenous (iv) lacosamide (LCM). For the first 20 participants in Cohort 2, iv LCM has been infused over a duration of 30 minutes but no longer than 60 minutes whenever possible. After completion of the first 20 participants in Cohort 2, a Data Monitoring Committee (DMC) reviewed the safety and tolerability data for this Cohort and made the following recommendations: the progression of the current Cohort, including iv infusion durations to be evaluated.
|
Lacosamide Age Cohort ≥ 8 - < 17 Years
n=55 Participants
This arm consisted of participants who formed Cohort 1, were ≥ 8 to \< 17 years of age and received at least 1 dose of iv LCM. For the first 20 participants in Cohort 1, iv LCM has been infused over a duration of 30 minutes but no longer than 60 minutes whenever possible. After completion of the first 20 participants in Cohort 1, a DMC reviewed the safety and tolerability data for this Cohort and made the following recommendations: the progression of the current Cohort, including iv infusion durations to be evaluated, and progression to initiate enrollment in the next Cohort (Cohort 2).
|
Total Title
n=103 Participants
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
48 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
3.840 years
STANDARD_DEVIATION 2.329 • n=5 Participants
|
12.662 years
STANDARD_DEVIATION 2.409 • n=7 Participants
|
8.551 years
STANDARD_DEVIATION 5.013 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
46 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other/Mixed
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Screening Period (Day -7 to Day -1) up to the End-of-Study Period (up to Day 37)Population: The Safety Set iv (SS-iv) included study participants in the Safety Set (SS) who received at least 1 dose of EP0060 study medication iv LCM.
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participant 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. 26 adverse events are reported splitting into at least 19 occurrences of individual pre-treatment emergent adverse events and 7 treatment emergent adverse events (TEAEs).
Outcome measures
| Measure |
Lacosamide Age Cohort ≥ 1 Month - < 8 Years (SS-iv)
n=48 Participants
This arm consisted of participants who formed Cohort 2, were ≥ 1 month to \< 8 years of age and received at least 1 dose of iv LCM. For the first 20 participants in Cohort 2, iv LCM has been infused over a duration of 30 minutes but no longer than 60 minutes whenever possible. After completion of the first 20 participants in Cohort 2, a DMC reviewed the safety and tolerability data for this Cohort and made the following recommendations: the progression of the current Cohort, including iv infusion durations to be evaluated. Participants formed the Safety Set iv (SS-iv).
|
Lacosamide Age Cohort ≥ 8 - < 17 Years (SS-iv)
n=55 Participants
This arm consisted of participants who formed Cohort 1, were ≥ 8 to \< 17 years of age and received at least 1 dose of iv LCM. For the first 20 participants in Cohort 1, iv LCM has been infused over a duration of 30 minutes but no longer than 60 minutes whenever possible. After completion of the first 20 participants in Cohort 1, a DMC reviewed the safety and tolerability data for this Cohort and made the following recommendations: the progression of the current Cohort, including iv infusion durations to be evaluated, and progression to initiate enrollment in the next Cohort (Cohort 2). Participants formed the Safety Set iv (SS-iv).
|
|---|---|---|
|
Percentage of Participants With at Least One Adverse Event Reported Spontaneously by the Participant/or Caregiver (Including Parent/Legal Guardian) or Observed by the Investigator During the Study
|
12.5 percentage of participants
|
14.5 percentage of participants
|
PRIMARY outcome
Timeframe: From Screening Period (Day -7 to Day -1) up to the End-of-Study Period (up to Day 37)Population: The Safety Set iv (SS-iv) included study participants in the Safety Set (SS) who received at least 1 dose of EP0060 study medication iv LCM.
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment and led to the withdrawal of the participants from the study. 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.
Outcome measures
| Measure |
Lacosamide Age Cohort ≥ 1 Month - < 8 Years (SS-iv)
n=48 Participants
This arm consisted of participants who formed Cohort 2, were ≥ 1 month to \< 8 years of age and received at least 1 dose of iv LCM. For the first 20 participants in Cohort 2, iv LCM has been infused over a duration of 30 minutes but no longer than 60 minutes whenever possible. After completion of the first 20 participants in Cohort 2, a DMC reviewed the safety and tolerability data for this Cohort and made the following recommendations: the progression of the current Cohort, including iv infusion durations to be evaluated. Participants formed the Safety Set iv (SS-iv).
|
Lacosamide Age Cohort ≥ 8 - < 17 Years (SS-iv)
n=55 Participants
This arm consisted of participants who formed Cohort 1, were ≥ 8 to \< 17 years of age and received at least 1 dose of iv LCM. For the first 20 participants in Cohort 1, iv LCM has been infused over a duration of 30 minutes but no longer than 60 minutes whenever possible. After completion of the first 20 participants in Cohort 1, a DMC reviewed the safety and tolerability data for this Cohort and made the following recommendations: the progression of the current Cohort, including iv infusion durations to be evaluated, and progression to initiate enrollment in the next Cohort (Cohort 2). Participants formed the Safety Set iv (SS-iv).
|
|---|---|---|
|
Percentage of Participants That Withdrew Due to Adverse Events During the Study
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
Lacosamide Age Cohort ≥ 1 Month - < 8 Years (SS-iv)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Lacosamide Age Cohort ≥ 8 - < 17 Years (SS-iv)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lacosamide Age Cohort ≥ 1 Month - < 8 Years (SS-iv)
n=48 participants at risk
This arm consisted of participants who formed Cohort 2, were ≥ 1 month to \< 8 years of age and received at least 1 dose of iv LCM. For the first 20 participants in Cohort 2, iv LCM has been infused over a duration of 30 minutes but no longer than 60 minutes whenever possible. After completion of the first 20 participants in Cohort 2, a DMC reviewed the safety and tolerability data for this Cohort and made the following recommendations: the progression of the current Cohort, including iv infusion durations to be evaluated. Participants formed the Safety Set iv (SS-iv).
|
Lacosamide Age Cohort ≥ 8 - < 17 Years (SS-iv)
n=55 participants at risk
This arm consisted of participants who formed Cohort 1, were ≥ 8 to \< 17 years of age and received at least 1 dose of iv LCM. For the first 20 participants in Cohort 1, iv LCM has been infused over a duration of 30 minutes but no longer than 60 minutes whenever possible. After completion of the first 20 participants in Cohort 1, a DMC reviewed the safety and tolerability data for this Cohort and made the following recommendations: the progression of the current Cohort, including iv infusion durations to be evaluated, and progression to initiate enrollment in the next Cohort (Cohort 2). Participants formed the Safety Set iv (SS-iv).
|
|---|---|---|
|
Gastrointestinal disorders
Functional gastrointestinal disorder
|
2.1%
1/48 • Number of events 1 • Treatment Emergent Adverse Events were reported from Visit 2/Day 1 until End of Study Period (29 to 37 days after Visit 2/Day 1).
1 participant could experience multiple adverse events.
|
0.00%
0/55 • Treatment Emergent Adverse Events were reported from Visit 2/Day 1 until End of Study Period (29 to 37 days after Visit 2/Day 1).
1 participant could experience multiple adverse events.
|
|
General disorders
Pyrexia
|
2.1%
1/48 • Number of events 1 • Treatment Emergent Adverse Events were reported from Visit 2/Day 1 until End of Study Period (29 to 37 days after Visit 2/Day 1).
1 participant could experience multiple adverse events.
|
0.00%
0/55 • Treatment Emergent Adverse Events were reported from Visit 2/Day 1 until End of Study Period (29 to 37 days after Visit 2/Day 1).
1 participant could experience multiple adverse events.
|
|
Infections and infestations
Respiratory tract infection
|
2.1%
1/48 • Number of events 1 • Treatment Emergent Adverse Events were reported from Visit 2/Day 1 until End of Study Period (29 to 37 days after Visit 2/Day 1).
1 participant could experience multiple adverse events.
|
0.00%
0/55 • Treatment Emergent Adverse Events were reported from Visit 2/Day 1 until End of Study Period (29 to 37 days after Visit 2/Day 1).
1 participant could experience multiple adverse events.
|
|
Infections and infestations
Respiratory tract infection viral
|
2.1%
1/48 • Number of events 1 • Treatment Emergent Adverse Events were reported from Visit 2/Day 1 until End of Study Period (29 to 37 days after Visit 2/Day 1).
1 participant could experience multiple adverse events.
|
0.00%
0/55 • Treatment Emergent Adverse Events were reported from Visit 2/Day 1 until End of Study Period (29 to 37 days after Visit 2/Day 1).
1 participant could experience multiple adverse events.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/48 • Treatment Emergent Adverse Events were reported from Visit 2/Day 1 until End of Study Period (29 to 37 days after Visit 2/Day 1).
1 participant could experience multiple adverse events.
|
3.6%
2/55 • Number of events 2 • Treatment Emergent Adverse Events were reported from Visit 2/Day 1 until End of Study Period (29 to 37 days after Visit 2/Day 1).
1 participant could experience multiple adverse events.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/48 • Treatment Emergent Adverse Events were reported from Visit 2/Day 1 until End of Study Period (29 to 37 days after Visit 2/Day 1).
1 participant could experience multiple adverse events.
|
1.8%
1/55 • Number of events 1 • Treatment Emergent Adverse Events were reported from Visit 2/Day 1 until End of Study Period (29 to 37 days after Visit 2/Day 1).
1 participant could experience multiple adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60