Epilepsy MedDRA version: 20.0 Level: PT Classification code 10015037 Term: Epilepsy System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Vimpat
Product Name: Lacosamide
Pharmaceutical Form: Syrup
INN or Proposed INN: LACOSAMIDE
CAS Number: 175481-36-4
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equ
Sponsors
UCB BIOSCIENCES, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All subjects in SP848 must fulfill the following inclusion criteria: - A signed informed consent form has been obtained from the parent/legal guardian and assent has been obtained from the subject, as required - Subject and caregiver (which may be a parent, legal guardian, or other delegated caregiver) are willing and able to comply with all study requirements, including maintaining a daily seizure diary Subjects who have participated in SP847 or other lacosamide (LCM) pediatric clinical studies in epilepsy must fulfill the following inclusion criteria: - Subject has completed SP847 (or the subject discontinued SP847 due to a dose reduction or status epilepticus) for the treatment of uncontrolled partial-onset seizures, or subject has participated in other LCM pediatric clinical studies in epilepsy - Subject is expected to benefit from participation, in the opinion of the investigator Subjects who enroll directly into SP848 without previous participation in a LCM clinical study must fulfill the following inclusion criteria: - Subject is >=4 years to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Not permitted to enroll in the study if any of the following criteria are met: - Subject is receiving any investigational drugs or using any experimental devices in addition to Lacosamide (LCM) - Subject >= 6 years of age has a lifetime history of suicide attempt, or has suicidal ideation in the past 6 months Subjects who have participated in SP847 or other LCM pediatric clinical studies in epilepsy are not permitted to enroll in the study if any of the following criteria are met: - Subject meets either of the following: a) Withdrawal criteria for the primary study (with the exception of subjects who discontinued due to a dose reduction or status epilepticus). For subjects entering from EP0060, if the subject (or legal guardian) withdraws consent solely due to route of LCM administration (iv) or if the subject requires more than 10 iv LCM infusions, the subject may be allowed to participant in SP848 after discussion with and agreement from the Medical Monitor b) Ongoing serious Adverse Event (SAE) Subjects who enroll directly into SP848 without previous participation in a LCM clinical study are not permitted to enroll in the study if any of the following criteria are met: - Subject has ever received LCM - 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. - Subject has a medical condition that could reasonably be expected to interfere with drug absorption, distribution, metabolism, or excretion - Subject has a known hypersensitivity to any component of the investigational medicinal product - Subject is a female of childbearing potential and does not practice an acceptable method of contraception for the duration of the study - Subject has a creatinine clearance less than 30mL/min - Subject has a clinically relevant 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) - Subject has hemodynamically significant heart disease (eg, heart failure) - Subject has an arrhythmic heart condition requiring medical therapy - Subject has a known history of severe anaphylactic reaction or serious blood dyscrasias - Subject has nonepileptic events, including psychogenic seizures, that could be confused with seizures. If both epileptic and nonepileptic events are present, epileptic events must be distinguished from nonepileptic phenomena - Subject has a history of primary generalized epilepsy - Subject is taking monoamine oxidase inhibitors-A (MAOI-A) or narcotic analgesics. - Subject has epilepsy secondary to a progressing cerebral disease or any other progressively neurodegenerative disease, such as Rasmussen syndrome - Subject has a known sodium channelopathy, such as Brugada syndrome - Subject has >2x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >ULN total bilirubin (1.5xULN total bilirubin if known Gilbert’s syndrome). If subject has elevations only in total bilirubin that are >ULN and <1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert’s syndrome (ie, direct bilirubin <35%) Subjects who were directly enrolled in EP0060 for iv LCM replacement therapy or to initiate LCM treatment are not permitted to enroll in the study if any of the following criteria are me
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objectives of this study are: • To obtain information about the safety, tolerability, and pharmacokinetics (PK) of Lacosamide (LCM) during long-term exposure • To obtain preliminary efficacy data on seizure frequency during long term exposure • To allow subjects who have participated in SP847 (or discontinued SP847 due to a dose reduction or status epilepticus) to continue receiving LCM • To allow subjects who have participated in other future LCM pediatric clinical studies in epilepsy to continue receiving LCM • Beginning with Protocol Amendment 4, at selected sites, to allow up to approximately 100 eligible pediatric subjects =4 years to =17 years of age who have not previously received LCM to begin receiving LCM ;Secondary Objective: See section E.2.1;Primary end point(s): 1 - Number of subjects who report at least one Treatment-emergent Adverse Event (TEAE) 2 - Number of subjects that withdraw due to a Treatment-emergent AE 3 - For children 18 months to 5 years, the mean change in Achenbach CBCL/11/2 -5 score from Baseline to end of treatment 4 - For children 6 years to 17 years, the mean change in Achenback CBCL/6-18 score from Baseline to end of treatment 5 - For children <18 months, the mean change in Bailey III score from Baseline to end of treatment 6 - For children aged 2 to 4 years, the mean change in BRIEF-P score from Baseline to end of treatment 7 - For children aged 5 to 17 years, the mean change in BRIEF score Baseline to end of treatment 8 - Percentage of subjects with a shift in Tanner Scale score from Baseline to End of Treatment ;Timepoint(s) of evaluation of this end point: 1-7. Baseline to end of treatment (approximately 2 years) 8. Visit 9; End of treatment (or early discontinuation visit) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change from Baseline in seizure frequency 2. Change from Baseline in seizure frequency 3. Mean Clinical Global Impression of Change score 4. Mean Clinical Global Impression of Change score 5. Mean Caregiver Global Impression of Change score 6. Mean Caregiver Global Impression of Change score 7. For children 1 month to 17 years, the mean change in PedsQL health summary score from Baseline to End of treatment 8. LCM Palatability and Ease of Use Questionnaire – Oral Solution 9. LCM Palatability and Ease of Use Questionnaire – Tablets;Timepoint(s) of evaluation of this end point: 1. Baseline to Visit 9 (approximately 1 year ) 2. Baseline to End of treatment (approximately 2 years) 3. Baseline to Visit 9 (approximately 1 year) 4. Baseline to End of treatment (approximately 2 years) 5. Baseline to Visit 9 (approximately 1 year) 6. Baseline to End of treatment (approximately 2 years) 7. Baseline to End of treatment (approximately 2 years) 8. Visit 9; End of treatment (or Early Discontinuation Visit) 9. Visit 9; End of treatment (or Early Discontinuation Visit) | — |
Countries
Belgium, China, France, Germany, Hungary, Italy, Japan, Mexico, Poland, Ukraine, United States
Contacts
Public ContactClin Trial Reg & Results Disclosure
UCB BIOSCIENCES GmbH
Outcome results
None listed