A trial to evaluate the saftey, tolerability, the absorption and distribution in the body of Lacosamide syrup as adjunctive therapy in children with patial onset seizures.

• Conditions: Epilepsy, partial onset seizures; MedDRA version: 14.1Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-001558-27-Outside-EU/EEA
• Lead Sponsor: CB BIOSCIENCES, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-11
• Last Update Posted: 15 July 2013

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

1. A signed informed consent has been obtained from the parent/legal guardian and assent has been obtained from the subject (when possible or as required according to local Institutional Review Boards/Independent Ethics Committees).
2. Subject and caregiver (which may be a parent, a legal guardian, or other caregiver) are willing and able to comply with all study requirements including maintaining a daily seizure diary.
3. Subject is male or female between 1 month (ie, 4 weeks after full term [37 weeks gestational age]) and 17 years of age inclusive. For preterm infants <1 year old, the corrected gestational age should be used when determining eligibility. The generally accepted definition of corrected gestational age, which is calculated by subtracting the number of weeks born before 37 weeks of gestation from the chronological age, will be used for this study.
4. Subject’s BMI is within the 5th to 95th percentile for his/her age group (subjects =2 years of age only; see Section 16.2), and subject must be a minimum of 5kg (11.0 pounds) in body weight.
5. Subject has a diagnosis of epilepsy with partial-onset seizures.
a. The results of at least 1 prior electroencephalogram (EEG) AND 1 prior magnetic resonance imaging/computerized tomography scan should be consistent with the above diagnosis.
6. Subject has been observed to have uncontrolled partial-onset seizures after an adequate course of treatment (in the opinion of the investigator) with at least 2 AEDs (concurrently or sequentially).
7. Subject has been observed to have at least 2 countable seizures in the 4 week period prior to Screening.
a. In the case of simple partial seizures, only those with motor signs will be counted towards meeting the inclusion criteria (only partial seizures with a recognizable and countable manifestation).
8. Subject is on a stable dosage regimen of 1 to 3 AEDs, which should remain stable throughout the course of the study. The daily dosage regimen of concomitant AED therapy must be kept constant for a period of at least 1 week prior to Screening. Vagal nerve stimulation is not counted as medical therapy; however, VNS settings must be kept constant for a period of at least 1 week prior to Screening and during the study.
9.Subject is an acceptable candidate for venipuncture.
Are the trial subjects under 18? yes
Number of subjects for this age range: 42
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

Exclusion Criteria

1. Subject is currently participating or has participated within the last 2 months in any study of an investigational drug or experimental device.
2. Subject has ever received LCM.
3. Subject has any medical or psychiatric condition that could jeopardize the subject’s health, compromise the subject’s ability to participate in this study, and/or confound the planned assessments of the study. Subject has any medical condition that would affect renal or hepatic clearance of LCM.
4. Subject with seizures that are uncountable due to clustering (ie, an episode lasting less than 30 minutes in which several seizures occur with such frequency that the initiation and completion of each individual seizure cannot be distinguished) during the 8-week period prior to study entry for subjects =1 year of corrected age or the 4 week period prior to study entry for subjects <1 year of corrected age).
5. Subject has a known hypersensitivity to any component of the investigational medicinal product.
6. Subject is a female of childbearing potential or the subject achieves menarche during the study and does not practice an acceptable method of contraception for the duration of the study.
• Medically acceptable contraceptive method includes oral or depot contraceptive treatment with at least 30µg ethinylestradiol per intake (or 50µg if associated with carbamazepine [or other strong enzyme inducers, eg, phenobarbital, primidone, oxcarbazepine]) which must be used in conjunction with a barrier method. Sexual abstinence is also an acceptable method of contraception.
• The subject must understand the consequences and potential risks of inadequately protected sexual activity, be educated about and understand the proper use of contraceptive methods, and undertake to inform the investigator of any potential change in status. Females of childbearing potential must have a negative pregnancy test at the Screening Visit (Visit 1).
7. Deleted and no longer applicable beginning with Protocol Amendment 4 (see protocol amendment details in Section 26, Section 27, and Section 28).
8. Subject has had or has a febrile illness within 2 weeks of dosing.
9. Subject is on a ketogenic or other specialized diet. If the subject was on a specialized diet in the past, they must be off the diet for at least 2 months prior to the Screening Visit.
10. 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 50mL/min.
11. 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).
12. Subject has hemodynamically significant heart disease (eg, heart failure).
13. Subject has an arrhythmic heart condition requiring medical therapy.
14. Subject has a known history of severe anaphylactic reaction or serious blood dyscrasias.
15. 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.
16. Subject has a history of primary generalized epilepsy. Subject <2 years of age has EEG findings or a clinical history of primary generalized epilepsy.
17. Subject =2 years of age has a history of status epilepticus within the 6 month period prior to Screen

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified