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Trial record 1 of 1 for:    NCT02710890
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Study to Investigate Safety and Tolerability of Intravenous Lacosamide in Children. (ASPIRE)

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ClinicalTrials.gov Identifier: NCT02710890
Recruitment Status : Completed
First Posted : March 17, 2016
Results First Posted : July 15, 2020
Last Update Posted : July 15, 2020
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES, Inc. )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Epilepsy
Intervention Drug: Lacosamide
Enrollment 103
Recruitment Details The study started to enroll participants in May 2017 and concluded in June 2019.
Pre-assignment Details Participant Flow refers to the Safety Set iv (SS-iv).
Arm/Group Title Lacosamide Age Cohort ≥ 1 Month - < 8 Years Lacosamide Age Cohort ≥ 8 - < 17 Years
Hide Arm/Group Description 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. 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).
Period Title: Overall Study
Started 48 55
Completed 48 55
Not Completed 0 0
Arm/Group Title Lacosamide Age Cohort ≥ 1 Month - < 8 Years Lacosamide Age Cohort ≥ 8 - < 17 Years Total Title
Hide Arm/Group Description 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. 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). [Not Specified]
Overall Number of Baseline Participants 48 55 103
Hide Baseline Analysis Population Description
Baseline characteristics refer to the Safety Set iv (SS-iv) which consisted of study participants in the Safety Set (SS) who received at least 1 dose of EP0060 study medication intravenous (iv) lacosamide (LCM)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 55 participants 103 participants
<=18 years
48
 100.0%
55
 100.0%
103
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 48 participants 55 participants 103 participants
3.840  (2.329) 12.662  (2.409) 8.551  (5.013)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 55 participants 103 participants
Female
26
  54.2%
31
  56.4%
57
  55.3%
Male
22
  45.8%
24
  43.6%
46
  44.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 55 participants 103 participants
Asian
0
   0.0%
1
   1.8%
1
   1.0%
Black
2
   4.2%
3
   5.5%
5
   4.9%
White
46
  95.8%
50
  90.9%
96
  93.2%
Other/Mixed
0
   0.0%
1
   1.8%
1
   1.0%
1.Primary Outcome
Title 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
Hide Description

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).

Time Frame From Screening Period (Day -7 to Day -1) up to the End-of-Study Period (up to Day 37)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Lacosamide Age Cohort ≥ 1 Month - < 8 Years (SS-iv) Lacosamide Age Cohort ≥ 8 - < 17 Years (SS-iv)
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 48 55
Measure Type: Number
Unit of Measure: percentage of participants
12.5 14.5
2.Primary Outcome
Title Percentage of Participants That Withdrew Due to Adverse Events During the Study
Hide Description 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.
Time Frame From Screening Period (Day -7 to Day -1) up to the End-of-Study Period (up to Day 37)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Lacosamide Age Cohort ≥ 1 Month - < 8 Years (SS-iv) Lacosamide Age Cohort ≥ 8 - < 17 Years (SS-iv)
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 48 55
Measure Type: Number
Unit of Measure: percentage of participants
0 0
Time Frame 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).
Adverse Event Reporting Description 1 participant could experience multiple adverse events.
 
Arm/Group Title Lacosamide Age Cohort ≥ 1 Month - < 8 Years (SS-iv) Lacosamide Age Cohort ≥ 8 - < 17 Years (SS-iv)
Hide Arm/Group Description 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). 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).
All-Cause Mortality
Lacosamide Age Cohort ≥ 1 Month - < 8 Years (SS-iv) Lacosamide Age Cohort ≥ 8 - < 17 Years (SS-iv)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/48 (0.00%)      0/55 (0.00%)    
Hide Serious Adverse Events
Lacosamide Age Cohort ≥ 1 Month - < 8 Years (SS-iv) Lacosamide Age Cohort ≥ 8 - < 17 Years (SS-iv)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/48 (0.00%)      0/55 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lacosamide Age Cohort ≥ 1 Month - < 8 Years (SS-iv) Lacosamide Age Cohort ≥ 8 - < 17 Years (SS-iv)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/48 (6.25%)      2/55 (3.64%)    
Gastrointestinal disorders     
Functional gastrointestinal disorder * 1  1/48 (2.08%)  1 0/55 (0.00%)  0
General disorders     
Pyrexia * 1  1/48 (2.08%)  1 0/55 (0.00%)  0
Infections and infestations     
Respiratory tract infection * 1  1/48 (2.08%)  1 0/55 (0.00%)  0
Respiratory tract infection viral * 1  1/48 (2.08%)  1 0/55 (0.00%)  0
Investigations     
Blood triglycerides increased * 1  0/48 (0.00%)  0 2/55 (3.64%)  2
Blood cholesterol increased * 1  0/48 (0.00%)  0 1/55 (1.82%)  1
1
Term from vocabulary, MedDRA16.1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB
Organization: Cares
Phone: +1844 599 ext 2273
EMail: UCBCares@ucb.com
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB BIOSCIENCES, Inc. )
ClinicalTrials.gov Identifier: NCT02710890    
Other Study ID Numbers: EP0060
2014-003294-42 ( EudraCT Number )
First Submitted: March 9, 2016
First Posted: March 17, 2016
Results First Submitted: June 26, 2020
Results First Posted: July 15, 2020
Last Update Posted: July 15, 2020