NCT03559673CompletedPhase 3
A study to learn if lacosamide is safe to take over a long period of time in children with epilepsy
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 22 Nov 2024
Brief summary (registry, in English)
Assess the long-term use of lacosamide oral solution dosed at 2mg/kg/day to 12mg/kg/day when administered to pediatric study participants with epilepsy who have completed NCT01964560 (EP0034) or NCT00938912 (SP848).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 19 (actual)
- First submitted
- 20 Feb 2023
- Start date
- 28 Dec 2020
- Lead sponsor
- UCB Biopharma
- Diseases
- Epilepsy
- NCT number
- NCT03559673
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 19
- 5 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 EP0034 or 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
Who the study is looking for
- 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
Age in the registry: - to 17 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Semmelweis University Coordinator of this site? Confirm its status | Budapest VIII | Hungary | Completed |
| Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaza Coordinator of this site? Confirm its status | Budapest Xiv | Hungary | Completed |
| Centrul National Clinic De Recuperare Neuropsihomotorie Copii Doctor Nicolae Robanescu Coordinator of this site? Confirm its status | Bucharest | Romania | Completed |
| Spitalul Clinic De Urgenta Pentru Copii Sfanta Maria Iasi Coordinator of this site? Confirm its status | Jassi | Romania | Completed |
| Spitalul Clinic de Urgenta pentru Copii Louis Turcanu Timisoara Coordinator of this site? Confirm its status | Timișoara | Romania | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.