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

Phase 1

Active, not recruiting

• Conditions: Epilepsy; MedDRA version: 21.0Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2020-001478-30-RO
• Lead Sponsor: CB Biopharma SR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-12
• Last Update Posted: 16 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

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
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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 Objective: Not applicable;Primary end point(s): 1. Incidence of treatment-emergent adverse events (TEAEs)<br>2. Withdrawals from study due to TEAEs<br>3. Withdrawals from study due to Serious Adverse Event (SAEs)<br>4. Modal daily dose during the study<br>5. Maximum daily dose during the study;Timepoint(s) of evaluation of this end point: From visit 1 (Week 0) to the end of study visit (up to Week 213)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable