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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

NCT ID: NCT04627285

Last Updated: 2025-08-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-28

Study Completion Date

2025-02-12

Brief Summary

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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).

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A Multicenter, Open-Label Study To Investigate The Safety And Pharmacokinetics Of Lacosamide In Children With Partial Seizures

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Detailed Description

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Conditions

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Epilepsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lacosamide

Subjects in this arm will receive various single doses of lacosamide

Group Type EXPERIMENTAL

Lacosamide

Intervention Type DRUG

* Pharmaceutical form: Oral-solution
* Route of administration: Oral use

Subjects will receive lacosamide in a pre-specified sequence during the Treatment Period.

Interventions

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Lacosamide

* Pharmaceutical form: Oral-solution
* Route of administration: Oral use

Subjects will receive lacosamide in a pre-specified sequence during the Treatment Period.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Biopharma SRL

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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UCB Cares

Role: STUDY_DIRECTOR

001 844 599 2273 (UCB)

Locations

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Ep0151 620

Tbilisi, , Georgia

Site Status

Ep0151 621

Tbilisi, , Georgia

Site Status

Ep0151 622

Tbilisi, , Georgia

Site Status

Ep0151 361

Budapest, , Hungary

Site Status

Ep0151 362

Budapest, , Hungary

Site Status

Ep0151 650

Chisinau, , Moldova

Site Status

Ep0151 581

Bucharest, , Romania

Site Status

Ep0151 582

Iași, , Romania

Site Status

Ep0151 577

Timișoara, , Romania

Site Status

Ep0151 224

Taipei, , Taiwan

Site Status

Ep0151 602

Dnipro, , Ukraine

Site Status

Ep0151 609

Dnipropetrovsk, , Ukraine

Site Status

Ep0151 606

Kiev, , Ukraine

Site Status

Ep0151 682

Uzhhorod, , Ukraine

Site Status

Ep0151 603

Vinnytsia, , Ukraine

Site Status

Countries

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Georgia Hungary Moldova Romania Taiwan Ukraine

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2020-001478-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2022-502639-21-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1286-3095

Identifier Type: OTHER

Identifier Source: secondary_id

EP0151

Identifier Type: -

Identifier Source: org_study_id

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