An open-label, multicenter, multinational study of lacosamide as first add-on anti epileptic drug (AED) treatment in subjects with partial onset seizures.ESTUDIO ABIERTO, MULTICÉNTRICO Y MULTINACIONAL DE LACOSAMIDA COMO PRIMER FÁRMACO ANTIEPILÉPTICO (FAE) COMPLEMENTARIO EN PACIENTES CON CRISIS DE INICIO PARCIAL.
- Conditions
- Epilepsy / EpilepsiaMedDRA version: 9.1Level: LLTClassification code 10015037Term: Epilepsy
- Registration Number
- EUCTR2009-011181-28-ES
- Lead Sponsor
- Schwartz Biosciences, INC - UCB Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 456
1. Subject is informed and given ample time and opportunity to think about his/her
participation and has given his/her written informed consent/2. Subject is willing and able to comply with all study requirements/3. Subject is male or female, between the age of 16 (EU and the rest of the world) or 17 (US) and 65 years of age, inclusive.
/4. Group 1: Subject has a diagnosis of epilepsy with simple partial seizures (motor
component) and/or complex partial seizures with or without secondary generalization
according to the International Classification of Epileptic Seizures (1981) (see
Section 16.1), is currently taking 1 AED, and has only been prescribed this 1 AED since time of diagnosis. Epilepsy diagnosis should be < or =12 months at the time of the Screening Visit. OR Group 2: Subject has a diagnosis of epilepsy with simple partial seizures (motor component) and/or complex partial seizures with or without secondary generalization according to the International Classification of Epileptic Seizures (1981) (see Section 16.1), is currently taking 1 to 3 AEDs, and has tried at least 2 prior AED treatment regimens (concurrently or sequentially). Epilepsy diagnosis should be > or = 5 years at the time of the Screening Visit/5. The minimum required seizure frequency during the 12 weeks prior to the Screening Visit is > or = 1 partial-onset seizure (IA, IB, or IC) per 28 days (based on investigator
assessment of subject report). In the case of simple partial seizures, only those with motor signs (IA1) will be counted towards meeting this inclusion criterion/6. The maximum allowed seizure frequency during the 12 weeks prior to the Screening
Visit is 40 partial-onset seizures with motor and/or non-motor component per 28 days(based on investigator assessment of subject report)/7. Subject must be able to provide documented evidence of seizure count for the 4 weeks prior to the Screening Visit/8. Subject has been maintained on a stable dose regimen of AED(s) for at least 28 days prior to Visit 1 and during the Screening Phase with or without additional concurrent stable VNS. The VNS must have been in place for at least 6 months prior to the Screening Visit with constant settings for at least 28 days prior to Visit 1 and during the Screening Phase.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
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
Subject : 1)has previously participated in this study or subject has previously been assigned to treatment in a LCM study or received treatment with LCM. 2)is currently participating or has participated within the last 2 months in any study of an investigational drug or experimental device. 3)has a seizure disorder characterized primarily by isolated auras (ie, simple partial seizures without observable motor signs). 4)has a history of primary generalized seizures. 5)has a history of status epilepticus within the 12-month period prior to Visit 1. 6)has 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 12-week period prior to Visit 1.
7)has a current or previous diagnosis of pseudoseizures, conversion disorders, or
other nonepileptic ictal events which could be confused with seizures. 8)has any medical or psychiatric condition, which in the opinion of the investigator, could jeopardize the subject?s health or would compromise the subject's ability to participate in this study. 9)has a history of suicide attempt, has received professional counseling for suicidal ideation, or is currently experiencing active suicidal ideation. 10)has a known hypersensitivity to any component of LCM as stated in Section7.1. 11) has a medical condition that could reasonably be expected to interfere with drug absorption, distribution, metabolism, or excretion. 12)has any history of alcohol or drug abuse within the previous 2 years. 13)has an acute or subacutely progressive central nervous system disease. 14)has a known history of severe anaphylactic reaction or serious blood dyscrasias. 15)has alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin levels > or = 2x the upper limit of normal (ULN) or has alkaline phosphatase levels > or = 3x the ULN at Visit 1. 16)has impaired renal function (ie, creatinine clearance [CLcr] is lower than
30mL/min) at Visit 1. Creatinine clearance will be estimated as follows: Adult males: CLcr = (140-age) x weight in kg/(72 x serum creatinine in mg/dL) Adult females: CLcr = [(140-age) x weight in kg/(72 x serum creatinine in mg/dL)] x 0.85. 17)has a sick sinus syndrome without a pacemaker, or second or third degree atrioventricular (AV) block. 18)has experienced a myocardial infarction in the last 3 months. 19)has New York Heart Association Class III or Class IV heart failure. 20)is pregnant or nursing and/or a woman of childbearing potential who is not surgically sterile, 2 years postmenopausal, or does not practice 2 combined methods of contraception (unless sexually abstinent) for the duration of the study. 21)with concomitant treatment of felbamate or previous felbamate therapy within the last 6 months prior to study entry. 22)has taken vigabatrin in the preceding 6 months. (Note: A subject with a history of vigabatrin treatment must have had a visual perimetry test at least 6 months following conclusion of treatment. The results of the visual perimetry test must have shown either no damage or a visual field defect associated with 1 of the following 2 conditions:a) there was no change from a visual field test done at some point while the subject was taking vigabatrin, or b) there was no change from a visual field test done shortly after stopping vigabatrin administration.).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method