Epilepsy
Conditions
Interventions
Trade Name: Vimpat
Product Name: Lacosamide
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: LACOSAMIDE
CAS Number: 175481-36-4
Concentration unit: mg milligram(s)
Concentration type: equa
Sponsors
UCB Biosciences, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 - Area under the concentration time curve at steady state (AUCss) for SPM 12809 - Average concentration over the dosing interval at steady state (Cav,ss) for Lacosamine - Average concentration over the dosing interval at steady state (Cav,ss) for SPM 12809 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - IIncidence of AEs reported - Subject withdrawals due to AEs ;Timepoint(s) of evaluation of this end point: At Day 1 for both secondary end points | — |
Countries
United States
Contacts
Public ContactUCB Clinical Trial Call Center
UCB Biosciences, Inc
Outcome results
None listed