A study to investigate the pharmacokinetics in children (aged 1 month to 17 years) with epilepsy, prescribed lacosamide.
- Conditions
- EpilepsyTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2014-002629-36-Outside-EU/EEA
- Lead Sponsor
- CB Biosciences, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 32
1.An Institutional Review Board /Independent Ethics Committee approved written Informed Consent form is signed and dated by the subject or by the parent(s) or legal representative. The Consent form or a specific Assent form, where required, will be signed and dated by minors.
2. Subject/legal representative is considered reliable and capable of adhering to the protocol, visit schedule, or medication intake according to the judgment of the investigator.
3. Subject is male or female, 1 month to 17 years of age. Note: For preterm infants <1 year old, the corrected gestational age should be used (calculated by subtracting the number of weeks born before 37 weeks of gestation from the chronological age).
4. Subject must be a minimum of 3kg (6.6 pounds) in body weight.
5. Subject has a diagnosis of epilepsy.
6. Subject has been prescribed lacosamide (LCM) for the treatment of epilepsy for at least 1 month prior to Screening and has not been prescribed or maintained on LCM for the purposes of participating in this study. Lacosamide 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 participation.
7. Subject is on a stable AED dosage regimen. The daily dosage regimen of concomitant AED(s) therapy must be kept stable for a period of at least 1 week (7 days) prior to participation.
8. Subject is an acceptable candidate for venipuncture.
Are the trial subjects under 18? yes
Number of subjects for this age range: 32
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 participated in this study.
2. Subject has participated in another study of an investigational medicinal product (IMP) or a medical device within the last 30 days prior to Visit 1, or is currently participating in another study of an IMP or a medical device.
3. Subject has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject’s ability to participate in this study.
4. The subject presents clinically significant abnormal BP and/or pulse rate, according to the investigator.
5. Subject is pregnant and/or nursing.
6. Subject is taking monoamine oxidase inhibitors (MAOIs) or narcotic analgesics.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of this study is to evaluate the Pharmacokinetics of lacosamide in children with epilepsy, aged 1 month to 17 years.;Secondary Objective: -;Timepoint(s) of evaluation of this end point: Up to 2 hours post-dose on Day 1 for all primary end points;Primary end point(s): - Area under the concentration time curve at steady state (AUCss) for Lacosamine<br>- Area under the concentration time curve at steady state (AUCss) for SPM 12809<br>- Average concentration over the dosing interval at steady state (Cav,ss) for Lacosamine<br>- Average concentration over the dosing interval at steady state (Cav,ss) for SPM 12809<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - IIncidence of AEs reported <br>- Subject withdrawals due to AEs<br>;Timepoint(s) of evaluation of this end point: At Day 1 for both secondary end points