EUCTR2007-005439-27-AT进行中（未招募）不适用
A Historical-controlled, Multicenter, Double-blind, Randomized Trial to Assess the Efficacy and Safety of Conversion to Lacosamide 400mg/day Monotherapy in Subjects with Partial-onset Seizures - ALEX-MT (A Lacosamide EXchange to Monotherapy Trial)
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 357
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Subject is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent.
- •2. Subject is willing and able to comply with all trial requirements.
- •3. Subject is male or female between the age of 16 and 70 years of age, inclusive.
- •4. 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.
- •5. Subject has been maintained on a stable dose of 1 or 2 marketed AEDs for at least 28 days prior to Visit 1 and during Baseline.
- •6. If a subject is on 2 AEDs, the second AED must be =50% of the minimum recommended maintenance dose per USA product label at Visit 1 and during Baseline when used as an adjunctive therapy.
- •7. The minimum required seizure frequency during the 8-week Baseline Phase is 2 partial-onset seizures (IA, IB, or IC) per 28 days. In the case of simple partial seizures, only those with motor signs (IA1) will be counted towards meeting this inclusion criterion. (See Section 15.2, International Classification of Epileptic Seizures, 1981.)
- •8. Subject has = 40 partial seizures (ie, IA1, IA2, IA3, IA4, IB, IC) per 28 days during the 8-week Baseline Phase. (See Section 15.2, International Classification of Epileptic Seizures, 1981.)
- •9. Subject has had an electroencephalogram and a brain computerized tomography scan or magnetic resonance imaging exam of the brain consistent with the diagnosis of partial-onset epilepsy. If the electroencephalogram and brain computerised tomography scan or magnetic resonance imaging exam were not performed prior to Visit 1, it needs to be completed and results must be available prior to randomisation at Visit 3.
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subject has previously participated in this trial, or subject has previously been assigned to treatment in a trial of the drug under investigation in this trial. Subjects who have previously received commercial LCM may be considered for participation if the treatment period was limited, and treatment was not discontinued due to intolerability or lack of efficacy. These cases must be discussed with the medical monitor prior to screening
- •2. Subject is currently participating or has participated within the last 2 months in any trial of an investigational drug or experimental device.
- •3. Subject has a seizure disorder characterized primarily by isolated auras (ie, simple partial seizures without observable motor signs).
- •4. Subject has a history of primary generalized or unclassified seizures.
- •5. Subject has a history of status epilepticus within the 12-month period prior to Visit 1.
- •6. Subject has a history of cluster seizures, defined as bouts of increased seizures which cannot be reliably counted (but which do not represent status epilepticus) during the 8-week period prior to Visit 1 and during the 8-week Baseline Phase.
- •7. Subject has a seizure-free period =28 consecutive days during the 8-week Baseline Phase.
- •8. Subject has >5 seizures of any type, including isolated auras, on any day during 8-week Baseline Phase.
- •9. Subject has a current or previous diagnosis of pseudoseizures, conversion disorders, or other non-epileptic ictal events which could be confused with seizures.
- •10. Subject has an implanted VNS.
- •11. Subject has received treatment with benzodiazepines, phenobarbital, or primidone within 28 days prior to Visit 1 or during Baseline.
- •12. Subject is taking 1 or more of the following medications on a regular basis within 28 days prior to Visit 1 or during Baseline: neuroleptics, monoamine oxidase (MAO) inhibitors, barbiturates, or narcotic analgesics.
- •13. Subject 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 trial.
- •14. Subject has a history of suicide attempt, has received professional counseling for suicidal ideation, or is currently experiencing active suicidal ideation.
- •15. Subject has a known hypersensitivity to any components of the investigational product(s) as stated in Section 4.4.2.
- •16. Subject has a medical condition that could reasonably be expected to interfere with drug absorption, distribution, metabolism or excretion.
- •17. Subject has any history of alcohol or drug abuse within the previous 2 years.
- •18. Subject has an acute or sub-acutely progressive central nervous system disease.
- •19. Subject with a known history of severe anaphylactic reaction or serious blood dyscrasias.
- •20. Subject weighs <40kg.
- •21. Subject has alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin levels =2 times the upper limit of normal (ULN) or has alkaline phosphatase levels =3 times the ULN at Visit 1.
- •22. Subject has impaired renal function, ie, creatinine clearance (CLCR) is lower than
- •50 mL/minute, at Visit 1. Creatinine clearance will be estimated by the central aboratory 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.
- •23. removed
- •24. removed
- •25. Subject has sick sinus syndrome without a pacemaker, or second- or thir
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