Study to investigate safety and tolerability of intravenous lacosamide as replacement of oral lacosamide in children.
- Conditions
- EpilepsyMedDRA version: 18.1Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2014-003294-42-IT
- 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
- 75
1. Subject is male or female from =4 to <17 years of age.
2. Subject is participating in a long-term, open-label study with lacosamide (LCM) or is currently prescribed
oral VIMPAT and needs to undergo a procedure, is admitted to an epilepsy monitoring unit (EMU) or health care facility, or other situations where intravenous (iv) administration of LCM is clinically appropriate.
3. Subject is an acceptable candidate for venipuncture and iv infusion.
Subjects who are participating in a long-term, open-label study with LCM must fulfill the
following additional inclusion criteria:
4. Subject is currently enrolled in a long-term, open-label study, receiving oral LCM for the
treatment of epilepsy.
5. Subject has been on a stable bid dosage regimen of oral LCM for the last 3 days in their
long-term, open-label study.
Subjects who are currently prescribed oral VIMPAT and enroll directly into EP0060 must fulfill
the following additional inclusion criteria:
6. Subject has been prescribed oral VIMPAT at a dose of 2mg/kg/day to 12mg/kg/day (for
subjects <50kg) or 100mg/day to 600mg/day (for subjects =50kg).
7. Subject has been prescribed oral VIMPAT for the treatment of epilepsy for at least 1 month
prior to Screening and has not been prescribed or maintained on VIMPAT for the purposes of
participating in EP0060. Prescribed oral VIMPAT dose must be stable for at least 7 days, and
intake of the prescribed total daily dose confirmed for at least 3 days prior to first infusion.
Are the trial subjects under 18? yes
Number of subjects for this age range: 75
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
1. Subject has previously received intravenous (iv) lacosamide (LCM) in this study.
2. 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.
3. Subject has clinically significant hypotension or bradycardia.
4. 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.
5. Subject does not have a diagnosis of epilepsy.
6. Subject is taking monoamine oxidase inhibitors (MAOIs).
Subjects who are participating in a long-term, open-label study with LCM are not permitted to
enroll in EP0060 if any of the following additional criteria are met:
7. 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.
Subjects who are currently prescribed oral VIMPAT are not permitted to directly enroll in
EP0060 if any of the following additional criteria are met:
8. Subject has a medical condition that could reasonably be expected to interfere with drug
distribution, metabolism, or excretion.
9. Subject has a known hypersensitivity to any component of the investigational medicinal
product (IMP).
10. Subject is a female of childbearing potential and does not practice an acceptable method of
contraception for the duration of participation in EP0060.
11. Subject has an alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total
bilirubin level greater than or equal to 2 times the upper limit of normal (ULN), or creatinine
clearance less than 30mL/min.
12. Subject has a clinically relevant electrocardiogram (ECG) abnormality, in the opinion of the principal investigator
(ie, second or third degree heart block at rest or a QT prolongation greater than 450ms).
13. Subject has hemodynamically significant heart disease (eg, heart failure).
14. Subject has an arrhythmic heart condition requiring medical therapy.
15. Subject has a known history of severe anaphylactic reaction or serious blood dyscrasias.
16. Subject has only nonepileptic events, including psychogenic seizures, which could be
confused with seizures. If both epileptic and nonepileptic events are present, epileptic events
must be distinguished from nonepileptic phenomena.
17. Subject has been treated with felbamate for at least 12 months prior to entering EP0060 and
has experienced any toxicity issues with this treatment. Note: Any subject who is currently treated with felbamate, and has received felbamate for a period of less than 12 months, is
excluded from EP0060.
18. Subject has an acute or subacutely progressive central nervous system disease. Subject has
epilepsy secondary to a progressing cerebral disease or any other progressive or
neurodegenerative disease (malignant brain tumor or Rasmussen syndrome).
19. Subject has a known cardiac sodium channelopathy, such as Brugada syndrome.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the safety and tolerability of intravenous (iv) lacosamide (LCM) infusion(s) in subjects =4 to <17 years of age with epilepsy, after temporarily switching from the equivalent stable oral LCM dose.;Secondary Objective: To evaluate the pharmacokinetics (PK) of intravenous (iv) lacosamide (LCM)<br>replacement in pediatric subjects with epilepsy.;Primary end point(s): 1) Number of subjects that withdraw due to treatment emergent adverse events during the study<br>2)Number of subjects experiencing at least one treatment emergent adverse event during the study<br>3) Number of subjects experiencing at least 1 injection-related treatment emergent adverse event during the study<br><br>;Timepoint(s) of evaluation of this end point: 1) During the treatment period (up to 5 days)<br>2) During the treatment period (up to 9 days)<br>3) During the treatment period (up to 5 days)<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not Applicable;Timepoint(s) of evaluation of this end point: Not Applicable