Clinical trial NCT04627285: A Study to Test the Long-term Use of Oral Lacosamide in Pediatric Study Participants Who Completed NCT01964560 (EP0034) or NCT00938912 (SP848) and Received Lacosamide Treatment
Official title: A Multicenter, Open-Label, Follow-Up Study to Assess the Long-Term Use of Oral Lacosamide in Study Participants Who Completed EP0034 or SP848 and Received Lacosamide Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Keywords: Lacosamide
Vimpat
Epilepsy
Pediatric
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2020-11-13
Enrollment: 48
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the long-term use of lacosamide oral solution dosed at 2 mg/kg/day to 12 mg/kg/day when administered to pediatric study participants with epilepsy who have completed NCT01964560 (EP0034) or NCT00938912 (SP848).


Eligibility criteria: Inclusion Criteria:

* Participant is male or female, aged \<6 years at the time of signing the Informed Consent Form (ICF)
* Participant has completed participation in NCT01964560 (EP0034) or NCT00938912 (SP848)
* Participant is expected to benefit from participation, in the opinion of the Investigator

Exclusion Criteria:

* Participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study
* Participant has a known hypersensitivity to any components of the study medication or comparative drugs as stated in this protocol
* Participant is receiving any investigational drugs or using any experimental devices in addition to lacosamide (LCM)
* Participant meets a mandatory withdrawal criterion (ie, MUST withdraw criterion) for NCT01964560 (EP0034) or NCT00938912 (SP848), or is experiencing an ongoing serious adverse event (SAE)
* Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates participation in the study

Primary outcomes:
measure: Incidence of treatment-emergent adverse events (TEAEs)
timeFrame: From visit 1 (Week 0) to the end of study visit (up to Week 213)
measure: Withdrawals from study due to TEAEs
timeFrame: From visit 1 (Week 0) to the end of study visit (up to Week 213)
measure: Withdrawals from study due to Serious Adverse Event (SAEs)
timeFrame: From visit 1 (Week 0) to the end of study visit (up to Week 213)
measure: Modal daily dose during the study
timeFrame: From visit 1 (Week 0) to the end of study visit (up to Week 213)
measure: Maximum daily dose during the study
timeFrame: From visit 1 (Week 0) to the end of study visit (up to Week 213)
Secondary outcomes:
Other outcomes:
Locations:
city: Tbilisi
country: Georgia
facility: Ep0151 620
city: Tbilisi
country: Georgia
facility: Ep0151 621
city: Tbilisi
country: Georgia
facility: Ep0151 622
city: Budapest
country: Hungary
facility: Ep0151 361
city: Budapest
country: Hungary
facility: Ep0151 362
city: Chisinau
country: Moldova, Republic of
facility: Ep0151 650
city: Bucuresti
country: Romania
facility: Ep0151 581
city: Iasi
country: Romania
facility: Ep0151 582
city: Timisoara
country: Romania
facility: Ep0151 577
city: Taipei
country: Taiwan
facility: Ep0151 224
city: Dnipropetrovsk
country: Ukraine
facility: Ep0151 609
city: Dnipro
country: Ukraine
facility: Ep0151 602
city: Kiev
country: Ukraine
facility: Ep0151 606
city: Uzhgorod
country: Ukraine
facility: Ep0151 682
city: Vinnytsya
country: Ukraine
facility: Ep0151 603
Study officials:
affiliation: 001 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References: