A MULTICENTER, OPEN-LABEL STUDY TO INVESTIGATE THE SAFETY AND TOLERABILITY OF INTRAVENOUS LACOSAMIDE IN CHILDREN (=4 TO <17 YEARS OF AGE) WITH EPILEPSY

CB BIOSCIENCES Inc.0 sites75 target enrollmentApril 7, 2017

ConditionsEpilepsy MedDRA version: 20.0 Level: PT Classification code 10015037 Term: Epilepsy System Organ Class: 10029205 - Nervous system disorders Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

DrugsVimpat

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Epilepsy
Sponsor: CB BIOSCIENCES Inc.
Enrollment: 75
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 7, 2017

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

CB BIOSCIENCES Inc.

Eligibility Criteria

Inclusion Criteria

•\- Male or female from \>\=4 to \<17 years of age
•\- Subject has a diagnosis of epilepsy with partial\-onset seizures or primary generalized tonic\-clonic seizures
•\- Subject meets 1 of the following criteria:
•a) Open\-label lacosmide (OLL) subject: Subject is currently receiving oral lacosmide (LCM) as adjunctive or monotherapy as participants in an open label long\-term study (SP848, EP0034, or other pediatric study); OR,
•b) Prescription lacosamide (RxL) subject: Subject is currently receiving prescribed oral LCM from commercial supply (eg, VIMPAT) as adjunctive or monotherapy; OR,
•c)Initiating intravenous lacosamide (IIL) subject: Subject is not currently receiving LCM and will receive intravenous (iv) LCM as adjunctive treatment in EP0060\. Initiation of LCM monotherapy is not permitted in IIL subjects.
•\- Subject is an OLL or RxL subject and meets both of the following criteria:
•a) Subject has been administered LCM for the treatment of epilepsy for at least 2 weeks prior to Screening; AND,
•b) Subject has been administered (OLL) or prescribed (RxL) oral LCM at a dose of 2mg/kg/day to 12mg/kg/day (for subjects \<50kg) or 100mg/day to 600mg/day (for subjects \>\=50kg). Open\-label study drug LCM (OLL) or prescribed oral LCM dose (RxL) must be stable for at least 3 days prior to first
•LCM infusion; OR,

Exclusion Criteria

•\- Subject has previously received intravenous (iv) lacosamide (LCM) in this study
•\- Subject has any medical, neurological, or psychiatric condition that, in the opinion of the investigator,
•could jeopardize the subject’s health or compromise the subject’s ability to participate in EP0060
•\- Subject has clinically significant hypotension or bradycardia in the opinion of the investigator
•\- Subject \>\=6 years of age 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 positive responses (Yes”) to either Question 4 or Question 5 of the Columbia\-Suicide Severity Rating Scale (C\-SSRS) at Screening
•For open\-label lacosamide (OLL) subjects, enrollment in EP0060 is not permitted if any of the following additional criteria are met:
•\- Subject has any ongoing Adverse Event (AE) in their long\-term, open\-label study that, in the opinion of the investigator, could jeopardize or would compromise the subject’s ability to participate EP0060 or the subject meets any of the criteria for required withdrawal from the long\-term open\-label study
•For prescription lacosamide (RxL) and initiating intravenous lacosamide (IIL) subjects, enrollment in EP0060 is not permitted if any of the following additional criteria are met:
•\- Subject has a medical condition that could reasonably be expected to interfere with drug absorption distribution, metabolism, or excretion
•\- Subject is a female of childbearing potential and does not practice an acceptable method of contraception for the duration of participation in EP0060