Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
49
Countries
2
Sites
5
Epilepsy
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).
Key facts
- Sponsor
- UCB Biopharma
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 28 Dec 2020 → 12 Feb 2025
- Decision date (initial)
- 2023-03-27
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- UCB Biopharma SRL, Allée de la Recherche 60, B-1070 Brussels, Belgium
External identifiers
- EU CT number
- 2022-502639-21-00
- EudraCT number
- 2020-001478-30
- WHO UTN
- U1111-1286-3095
- ClinicalTrials.gov
- NCT03559673
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Therapy
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).
Secondary objectives 1
- Not applicable
Conditions and MedDRA coding
Epilepsy
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10015037 | Epilepsy | 100000004852 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- - 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 1
- - 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 1. Incidence of treatment-emergent adverse events (TEAEs) 2. Withdrawals from study due to TEAEs 3. Withdrawals from study due to Serious Adverse Event (SAEs) 4. Modal daily dose during the study 5. Maximum daily dose during the study
Secondary endpoints 1
- Not applicable
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD236256 · Product
- Active substance
- Lacosamide
- Pharmaceutical form
- SYRUP
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 205 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- UCB BIOSCIENCES, INC.
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
UCB Biopharma
- Sponsor organisation
- UCB Biopharma
- Address
- Researchdreef 60
- City
- Anderlecht
- Postcode
- 1070
- Country
- Belgium
Scientific contact point
- Organisation
- UCB Biopharma
- Contact name
- UCB Cares
Public contact point
- Organisation
- UCB Biopharma
- Contact name
- UCB Cares
Third parties 2
| Organisation | City, country | Duties |
|---|---|---|
| Parexel International (IRL) Limited ORG-100022780
|
Dublin 2, Ireland | Interactive response technologies (IRT) |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | On site monitoring, Code 12, Code 13, Code 14, Code 2, Interactive response technologies (IRT), Code 5, Data management, E-data capture, Code 8 |
Locations
2 EU/EEA countries · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Hungary | Ended | 13 | 2 |
| Romania | Ended | 6 | 3 |
| Rest of world
Georgia, Taiwan, Ukraine, Moldova, Republic of
|
— | 30 | — |
Investigational sites
Semmelweis University
#361: Paediatrics-Neurology, Bokay Janos Utca 53, 1083, Budapest VIII
Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaza
#362: Neurology, Bethesda Utca 3, 1146, Budapest Xiv
Spitalul Clinic De Urgenta Pentru Copii Louis Turcanu Timisoara
#577: Paediatrics-Neurology, Strada Corbului Nr 7, 300239, Timisoara
Spitalul Clinic De Urgenta Pentru Copii Sfanta Maria Iasi
#582: Paediatric-Neurology, Strada Vasile Lupu Nr 62, 700309, Jassi
Centrul Național Clinic De Recuperare Neuropsihomotorie Copii Doctor Nicolae Robanescu
#581: Paediatrics-Neurology, Strada Sold Dumitru Minca 44 Sector 4, 041408, Bucharest
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Hungary | 2020-12-28 | 2025-02-11 | 2020-12-28 | 2022-02-16 | |
| Romania | 2021-06-25 | 2025-01-13 | 2021-06-25 | 2022-01-18 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Summary of Results SUM-93962
|
2025-08-12T13:14:04 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Lay person summary of results | 2025-08-12T13:14:29 | Submitted | Laypersons Summary of Results |
Documents 12 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | EP0151-plain-language-summary | 1.0 |
| Laypersons summary of results (for publication) | EP0151-plain-language-summary-hu-HU | 1.0 |
| Laypersons summary of results (for publication) | EP0151-plain-language-summary-ro-RO | 1.0 |
| Recruitment arrangements (for publication) | EP0151 EUCTR-Transition-Blank Document part2 recruitment arrangements Hungary | v1.0 |
| Subject information and informed consent form (for publication) | ep0151-hu-si-and-icf-parent-public-hu-HU | 2.0 |
| Subject information and informed consent form (for publication) | ep0151-hu-si-iaf-min-public-hu-HU | 2.0 |
| Subject information and informed consent form (for publication) | ep0151-hu-subject-id-card-public-hu-HU | 1.0 |
| Subject information and informed consent form (for publication) | EP0151-hungary-icf-children-public-hungarian | v1 |
| Subject information and informed consent form (for publication) | EP0151-hungary-icf-parent_legal guardian-public | v1.1 |
| Subject information and informed consent form (for publication) | EP0151-hungary-si-children-public-hungarian | v1 |
| Subject information and informed consent form (for publication) | EP0151-hungary-si-parent_legal guardian-public | v1.1 |
| Summary of results (for publication) | EP0151-Summary of Final Results | 1.0 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-02-20 | Hungary | Acceptable 2023-03-21
|
2023-03-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-12-05 | Hungary | Acceptable 2024-02-19
|
2024-02-23 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-11-14 | Hungary | Acceptable 2024-02-19
|
2024-11-14 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-11-22 | Hungary | Acceptable 2024-02-19
|
2024-11-22 |