Study to Investigate Safety and Tolerability of Intravenous Lacosamide in Children.
ASPIRE
A Multicenter, Open-Label Study to Investigate the Safety and Tolerability of Intravenous Lacosamide in Children (>= 1 Month to < 17 Years of Age) With Epilepsy
2 other identifiers
interventional
103
5 countries
23
Brief Summary
EP0060 is a multicenter, open-label study to evaluate the safety and tolerability of intravenous (iv) Lacosamide (LCM) in pediatric subjects \>= 1 month to \< 17 years of age with epilepsy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2017
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2016
CompletedFirst Posted
Study publicly available on registry
March 17, 2016
CompletedStudy Start
First participant enrolled
May 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2019
CompletedResults Posted
Study results publicly available
July 15, 2020
CompletedFebruary 23, 2023
November 1, 2020
2.1 years
March 9, 2016
June 26, 2020
February 22, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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).
From Screening Period (Day -7 to Day -1) up to the End-of-Study Period (up to Day 37)
Percentage of Participants That Withdrew Due to Adverse Events During the Study
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.
From Screening Period (Day -7 to Day -1) up to the End-of-Study Period (up to Day 37)
Study Arms (1)
Lacosamide
EXPERIMENTALUp to 2 age-based Cohorts with Cohort 1 including at least 40 subjects who are \>=8 to \<17 years. For Cohort 2 every attempt will be made to enroll 20 subjects \>= 4 to \< 8 years of age, 12 subjects \>= 2 to \< 4 years of age and 12 subjects \>= 1 month to \< 2 years of age. A Data Monitoring Committee (DMC) will review the safety and tolerability data for each Cohort to make the following recommendations: the progression of the current Cohort, including intravenous (iv) infusion durations to be evaluated, and progression to initiate enrollment in the next Cohort (Cohort 2).
Interventions
Pharmaceutical form: solution for infusion Concentration: 10 mg/ml Route of Administration: intravenous
Eligibility Criteria
You may qualify if:
- Male or female from \>=1 month to \<17 years of age
- Subject has a diagnosis of epilepsy with partial-onset seizures or primary generalized tonic-clonic seizures
- Subject meets 1 of the following criteria:
- Open-label lacosmide (OLL) subject: Subject is currently receiving oral lacosmide (LCM) as adjunctive or monotherapy as participants in an open label long-term study (SP848, EP0034, or other pediatric study); OR,
- Prescription lacosamide (RxL) subject: Subject is currently receiving prescribed oral LCM from commercial supply (eg, VIMPAT) as adjunctive or monotherapy; OR,
- Initiating intravenous lacosamide (IIL) subject: Subject is not currently receiving LCM and will receive intravenous (iv) LCM as adjunctive treatment in EP0060. Initiation of LCM monotherapy is not permitted in IIL subjects.
- Subject is an OLL or RxL subject and meets both of the following criteria:
- Subject has been administered LCM for the treatment of epilepsy for at least 2 weeks prior to Screening; AND
- Subject has been administered (OLL) or prescribed (RxL) oral LCM at a dose of 2 mg/kg/day to 12 mg/kg/day (for subjects \<50 kg) or 100 mg/day to 600 mg/day (for subjects \>=50 kg). Open-label study drug LCM (OLL) or prescribed oral LCM dose (RxL) must be stable for at least 3 days prior to first LCM infusion; OR,
- Subject is an ILL subject and is on a stable dosage regimen of at least 1 antiepileptic drug (AED). The daily dosage regimen of concomitant AED therapy must be kept constant for a period of at least 2 weeks prior to Screening.
- Subject is an acceptable candidate for venipuncture and iv infusion
- Subject is, in the opinion of the investigator, able to comply with all study requirements. Subject (or parent\[s\] or legal representative) is willing to comply with all study requirements
- Subject weighs \>=4 kg
You may not qualify if:
- Subject has previously received intravenous (iv) lacosamide (LCM) in this study
- Subject has any medical, neurological, or psychiatric condition that, in the opinion of the investigator, could jeopardize the subject's health or compromise the subject's ability to participate in EP0060
- Subject has clinically significant hypotension or bradycardia in the opinion of the investigator
- Subject \>=6 years of age has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by positive responses ("Yes") to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening
- For open-label lacosamide (OLL) subjects, enrollment in EP0060 is not permitted if any of the following additional criteria are met:
- \- Subject has any ongoing Adverse Event (AE) in their long-term, open-label study that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate EP0060 or the subject meets any of the criteria for required withdrawal from the long-term open-label study
- For prescription lacosamide (RxL) and initiating intravenous lacosamide (IIL) subjects, enrollment in EP0060 is not permitted if any of the following additional criteria are met:
- Subject has a medical condition that could reasonably be expected to interfere with drug absorption distribution, metabolism, or excretion
- Subject is a female of childbearing potential and does not practice an acceptable method of contraception for the duration of participation in EP0060
- Subject has creatinine clearance less than 30 mL/min
- Subject has a clinically relevant electrocardiogram (ECG) abnormality, in the opinion of the principal investigator (ie, second or third degree heart block at rest or a QT prolongation greater than 450 ms)
- Subject has hemodynamically significant heart disease (eg, heart failure)
- Subject has an arrhythmic heart condition requiring medical therapy, known cardiac sodium channelopathy, such as Brugada syndrome
- Subject has a known history of severe anaphylactic reaction or serious blood dyscrasias
- Subject has an acute or subacutely progressive central nervous system disease.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Ep0060 003
Birmingham, Alabama, 35233, United States
Ep0060 010
Little Rock, Arkansas, 72202, United States
Ep0060 008
Loxahatchee Groves, Florida, 33470, United States
Ep0060 009
Saint Paul, Minnesota, 55101, United States
Ep0060 014
Henderson, Nevada, 89104, United States
Ep0060 002
New Brunswick, New Jersey, 08903, United States
Ep0060 006
Akron, Ohio, 44308, United States
Ep0060 011
Cincinnati, Ohio, 45229, United States
Ep0060 005
Dallas, Texas, 75235, United States
Ep0060 007
San Antonio, Texas, 78258, United States
Ep0060 400
Budapest, Hungary
Ep0060 401
Debrecen, Hungary
Ep0060 503
Messina, Italy
Ep0060 505
Roma, Italy
Ep0060 502
Verona, Italy
Ep0060 701
Krakow, Poland
Ep0060 224
Dnipro, Ukraine
Ep0060 225
Dnipro, Ukraine
Ep0060 220
Ivano-Frankivsk, Ukraine
Ep0060 221
Kiev, Ukraine
Ep0060 222
Kiev, Ukraine
Ep0060 226
Kiev, Ukraine
Ep0060 223
Vinnytsia, Ukraine
Related Publications (1)
Farkas MK, Beller C, Bozorg A, McClung C, Roebling R, Yates T, Yuen N, Makedonska I. Safety and tolerability of short-term infusions of intravenous lacosamide in pediatric patients with epilepsy: An open-label, phase 2/3 trial. Epilepsia Open. 2023 Mar;8(1):146-153. doi: 10.1002/epi4.12682. Epub 2023 Jan 18.
PMID: 36529709RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Study Officials
- STUDY DIRECTOR
UCB Cares
+1 8445992273 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
March 9, 2016
First Posted
March 17, 2016
Study Start
May 30, 2017
Primary Completion
June 28, 2019
Study Completion
June 28, 2019
Last Updated
February 23, 2023
Results First Posted
July 15, 2020
Record last verified: 2020-11