NL-OMON37460撤回3 期
A PROSPECTIVE, MULTINATIONAL, OPEN-LABEL, SINGLE-ARM, EXPLORATIVE STUDY TO EVALUATE THE TOLERABILITY AND EFFICACY OF LACOSAMIDE WHEN ADDED TO LEVETIRACETAM WITH WITHDRAWAL OF THE CONCOMITANT SODIUM CHANNEL BLOCKING ANTIEPILEPTIC DRUG IN SUBJECTS WITH UNCONTROLLED PARTIAL-ONSET SEIZURES - Optimising Combination Therapy On Partial Onset Seizures (OCToPOS)
CB Biosciences Inc0 个研究点目标入组 25 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved
- •written Informed Consent form is signed and dated by the subject or legal representative.
- •2. Subject/legal representative is considered reliable and capable of adhering to the protocol
- •(eg, able to understand and complete diaries), visit schedule, and medication intake
- •according to the judgment of the investigator.
- •3. Subject is male or female, at least 18 years of age.
- •4. Subject has a diagnosis of epilepsy with partial-onset seizures according to the
- •International Classification of Epileptic Seizures (1981).
- •5. Subject is taking LEV in combination with 1 SCB-AED (defined as carbamazepine,
- •lamotrigine, oxcarbazepine, phenytoin, or eslicarbazepine) as adjunctive treatment for
- •6. The minimum required seizure frequency during the 8-week Retrospective Seizure
- •Baseline is on average >=2 partial-onset seizures (IA, IB, or IC) per 28 days (based on
- •investigator assessment of subject report) with at least 1 seizure per 4-week period within
- •the 8-week Retrospective Seizure Baseline. Additionally, subjects must experience at
- •least 1 seizure during the 4-week Prospective Seizure Baseline. In the case of simple
- •partial seizures, only those with motor signs (IA1) will be counted towards meeting this
- •inclusion criterion.
- •7. Subject has been maintained on a stable dose of LEV and a SCB-AED for at least
- •4-weeks prior to the Screening Visit (Visit 1) and during the 4-week Prospective Seizure
- •Baseline, with or without additional concurrent stable VNS. The VNS must have been in
- •place for at least 6 months prior to the Screening Visit (Visit 1) with constant settings for
- •at least 4-weeks prior to the Screening Visit (Visit 1) and throughout the duration of the
排除标准
- •1. Subject has previously participated in this study or subject has previously been exposed to
- •2. Subject has participated in another study of an investigational medicinal product (IMP) or
- •an experimental medical device within the last 2 months or is currently participating in
- •another study of an IMP or a medical device.
- •3. Female subject who 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. Male subject
- •who does not agree to practice 2 combined methods of contraception (eg, condom,
- •spermicide), unless sexually abstinent, for the duration of the study.
- •4. Subject has a history of chronic alcohol or drug abuse within the last 2 years.
- •5. Subject has a seizure disorder characterized primarily by isolated auras (ie, simple partial
- •seizures without observable motor signs).
- •6. Subject has a history of primary generalized seizures.
- •7. Subject has a history of status epilepticus within the 12-month period prior to Visit 1.
- •8. Subject 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 8-week
- •Retrospective Seizure Baseline and during the 4-week Prospective Seizure Baseline.
- •9. Subject has a current or previous diagnosis of pseudoseizures, conversion disorders, or
- •other nonepileptic ictal events which could be confused with seizures.
- •10. Subject has any medical or psychiatric condition that, in the opinion of the investigator,
- •could jeopardize the subject*s health or would compromise the subject*s ability to
- •participate in this study.
- •11. Subject has a lifetime history of suicide attempt (including an active attempt, interrupted
- •attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by
- •a positive response (*Yes*) to either Question 4 or Question 5 of the Columbia-Suicide
- •Severity Rating Scale (C-SSRS) at Screening.
- •12. Subject has a known hypersensitivity to any components of LCM tablets.
- •13. Subject has taken an AED other than the current SCB-AED and LEV during the 4-weeks
- •prior to the Screening Visit (Visit 1), excepting 1-time use of benzodiazepines as rescue
- •medication (less than or equal to 3 doses within 24 hours).
- •14. Subject has a medical condition that could reasonably be expected to interfere with drug
- •absorption, distribution, metabolism, or excretion.
- •15. Subject has an acute or sub-acute progressive central nervous system disease.
- •16. Subject has a known history of severe anaphylactic reaction or serious blood dyscrasias.
- •17. Subject has alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total
- •bilirubin levels >=2x the upper limit of normal (ULN) or has alkaline phosphatase levels
- •>=3xULN at Visit 1.
- •18. Subject 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
- •19. Subject
研究者
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