EUCTR2018-001337-41-CZ进行中（未招募）1 期
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Cenobamate Adjunctive Therapy in Subjects with Primary Generalized Tonic-Clonic Seizures
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 152
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
入选标准
- •1. Subject is male or female and aged =18 years.
- •2. Written informed consent signed by the subject or legal guardian, prior to entering the study, in accordance with the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines. If the
- •written informed consent is provided by the legal guardian because the
- •subject is unable to do so, a written or verbal assent from the subject
- •must also be obtained. As required by country-specific regulations, only
- •the subject may sign the ICF in accordance with ICH guidelines.
- •3. Female subjects of childbearing potential are willing to use an acceptable
- •form of birth control
- •4. Subject has a clinical diagnosis of PGTC seizures (with or without other
- •subtypes of generalized seizures) in the setting of idiopathic generalized
- •5. Subject experiences at least 5 PGTC seizures in 12 weeks during the
- •Pre-Randomization Period.
- •6. Subject has had a routine electroencephalogram (EEG) within 5 years
- •prior to Visit 1 (Screening/Baseline) or during the Pre-Randomization
- •Period with electroencephalographic features consistent with idiopathic
- •generalized epilepsy; other concomitant anomalies must be explained by
- •adequate past medical history.
- •7. Subject has undergone computed tomography (CT) or magnetic
- •resonance imaging (MRI) within 10 years prior to Visit 1
- •(Screening/Baseline) or during the Pre-Randomization Period that ruled
- •out a progressive cause of epilepsy.
- •8. Subject is currently receiving 1 to a maximum of 3 concomitant
- •antiepileptic drugs (AEDs) with fixed dosing regimens for a minimum
- •of 30 days prior to Visit 1 (Screening/Baseline).
- •a) Benzodiazepines (except diazepam, see Exclusion Criterion No. 7)
- •taken at least once per week during the 30 days prior to Visit 1
- •(Screening/Baseline) for epilepsy, anxiety, or sleep disorder will be
- •counted as 1 AED and the dosage must be continued unchanged
- •throughout the study. Therefore, only a maximum of 2 additional
- •approved AEDs will be allowed. (See Exclusion Criterion No. 10
- •for intermittent benzodiazepine rescue parameters.)
- •b) Subjects receiving felbamate as a concomitant AED must meet the
- •following criteria:
- •i. Have a 2-year history of felbamate use and a history of a fixed
- •dosing regimen for a minimum of 60 days prior to Visit 1
- •(Screening/Baseline).
- •ii. No prior or known history of hepatotoxicity or hematologic
- •disorder due to felbamate.
- •9. Subject with an implanted vagal nerve or deep brain stimulator will be
- •allowed if the stimulator was implanted at least 5 months prior to Visit 1
- •(Screening/Baseline) and the stimulator parameters are not changed for
- •30 days prior to Visit 1 and for the duration of the study.
- •10. Subject taking a ketogenic diet will be allowed as long as the diet has
排除标准
- •1. Female subjects who are pregnant (or planning to become pregnant
- •during the study), lactating, or breast-feeding.
- •2. Subject has a history of status epilepticus that required hospitalization
- •within 12 months prior to Visit 1 (Screening/Baseline).
- •3. Subject has PGTC seizure clusters where individual seizures cannot be
- •counted or classified.
- •4. Subject has a history of non-epileptic psychogenic seizures.
- •5. Subject has a concomitant diagnosis of partial onset seizure (POS).
- •6. Subject has a clinical diagnosis of Lennox-Gastaut syndrome.
- •7. Subject is currently taking (within the 30 days prior to Visit 1
- •[Screening/Baseline]) any of the following medications: diazepam (for
- •any reason other than as intermittent benzodiazepine rescue medication),
- •phenytoin, mephenytoin, fosphenytoin, phenobarbital, primidone,
- •ethotoin, clopidogrel, fluvoxamine, amitriptyline, clomipramine,
- •bupropion, methadone, ifosfamide, cyclophosphamide, or efavirenz.
- •8. Subject has participated in previous cenobamate clinical studies.
- •9. Subject has a history of vigabatrin use within 5 months prior to Visit 1
- •(Screening/Baseline), or the subject plans to begin treatment with
- •vigabatrin during the study.
- •a) A subject with a history of vigabatrin use that ended more than
- •5 months prior to Visit 1 may be enrolled after documented evidence
- •of no vigabatrin-associated clinically significant abnormality in an
- •automated visual perimetry test.
- •10. Subject has a history of intermittent use of rescue benzodiazepines (i.e.,
- •1 to 2 doses over a 24-hour period is considered a 1-time rescue) 4 or
- •more times within the 30 days prior to Visit 1 (Screening/Baseline).
- •11. Subject has received an investigational drug or device within 30 days
- •prior to Visit 1 (Screening/Baseline).
- •12. Subject has a history of drug or alcohol dependency or abuse within
- •2 years prior to Visit 1 (Screening/Baseline).
- •13. Subject tests positive, via urine drug screen at Visit 1
- •(Screening/Baseline), for illicit drugs (e.g., tetrahydrocannabinol,
- •amphetamines) or for a drug that has not been prescribed (e.g., certain
- •14. Subject has a history of any serious drug-induced hypersensitivity
- •reaction (including, but not limited to, Stevens Johnson syndrome, toxic epidermal necrolysis, or Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS]) or any drug-related rash requiring hospitalization.
- •15. History of AED-associated rash that involved conjunctiva or mucosae.
- •16. History of more than one non-serious drug-related hypersensitivity
- •reaction that required discontinuation of the medication.
- •17. Subject has evidence of clinically significant abnormalities or disease
- •(e.g., psychiatric, cardiac, respiratory, gastrointestinal, hepatic [AST or
- •ALT more than 2 times the upper limit of normal (ULN), o
研究者
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