A CLINICAL STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF LACOSAMIDE AS AN ADD ON THERAPY IN CHILDREN WITH EPILEPSY WITH PARTIAL ONSET SEIZURES

Phase 1

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

Registration Number: EUCTR2012-005012-26-PL

Lead Sponsor: CB Biosciences Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 500

Inclusion Criteria

1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form (ICF) is signed and dated by the subject or legal representative. The ICF or a specific Assent form, where required, will be signed and dated by minors.
2. Subject has completed the Transition Period of SP0967 or SP0969 for the treatment of uncontrolled partial-onset seizures in pediatric epilepsy.
3. Subject is expected to benefit from participation, in the opinion of the investigator.
4. Subject/legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the investigator.
5. Subject is male or female aged 1 month to = 17 years
6. Subject has a diagnosis of epilepsy with partial-onset seizures
Are the trial subjects under 18? yes
Number of subjects for this age range: 500
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

1. Subject is receiving any investigational drugs or using any experimental devices in addition to lacosamide.
2. Subject meets a mandatory withdrawal criterion (ie, MUST withdraw criterion) for SP0967 or SP0969, or is experiencing an ongoing serious AE (SAE).
3. For subjects =6 years of age, subject has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response (Yes”) to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Visit 1.

5. Female subject who is pregnant or nursing, and/or a female subject of childbearing potential who is not surgically sterile or does not practice 1 highly effective method of contraception (according to the International Conference on Harmonisation [ICH] guidance defined as those that result in a failure rate <1% per year when used consistently and correctly), unless sexually abstinent, for the duration of the study. Female subject of childbearing potential taking enzyme-inducing antiepileptic drugs (EI-AEDs: carbamazepine, phenytoin, barbiturates, primidone, topiramate, oxcarbazepine) who is not surgically sterile or does not practice 1 highly effective method of contraception according to the World Health Organization recommendation (ie, depot medroxyprogesterone acetate, norethisterone enantate, intrauterine devices, combined injectables, and progestogen implants) with administration of EI-AEDs OR does not practice 2 combined methods of contraception (ie, combined hormonal contraception plus barrier method with spermicidal agent), unless sexually abstinent, for the duration of the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the long-term safety and tolerability of lacosamide in pediatric subjects;Secondary Objective: To assess the efficacy of lacosamide during long-term exposure in pediatric subjects;Primary end point(s): 1) Number of subjects reporting at least one Treatment-emergent Adverse Event (TEAE) during the study<br>2) Number of subjects reporting at least one Treatment-emergent Adverse Event (TEAE) leading to discontinuation from the study<br>;Timepoint(s) of evaluation of this end point: 1) From Baseline to End of Treatment period<br>2) From Baseline to End of Treatment<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Percentage of seizure free days at the end of Year 1; <br>2) Percentage of seizure free days at end of Year 2;Timepoint(s) of evaluation of this end point: 1) End of Year 1 of the Study (approximately 52 weeks)<br>2) End of Year 2 of the Study (approximately 96 weeks)

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