NCT04627285CompletedPhase 3
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
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: ClinicalTrials.gov · Last updated 28 Aug 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 48 (actual)
- First submitted
- 12 Nov 2020
- Start date
- 28 Dec 2020
- Primary completion date
- 12 Feb 2025
- Lead sponsor
- UCB Biopharma SRL
- Diseases
- Epilepsy
- NCT number
- NCT04627285
- EU CT number
- 2022-502639-21-00
- EudraCT number
- 2020-001478-30
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 48
- From 28 Dec 2020 to the primary completion date, 12 Feb 2025
- 15 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participant is receiving any investigational drugs or using any experimental devices in addition to lacosamide (LCM)
Other illness
- 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
- 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
Other
- 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)
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: 2 years to 5 years · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.