EUCTR2017-002628-26-DE进行中（未招募）1 期
A Two-Part Study of ZX008 in Children and Adults withLennox-Gastaut Syndrome (LGS); Part 1: A Randomized,Double-blind, Placebo-controlled Trial of Two Fixed Dosesof ZX008 (Fenfluramine Hydrochloride) Oral Solution asAdjunctive Therapy for Seizures in Children and Adults withLGS, Followed by Part 2: An Open-label Extension toAssess Long-Term Safety of ZX008 in Children and Adultswith LGS
Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc.0 个研究点目标入组 250 人开始时间: 2018年4月11日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
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 male or nonpregnant, nonlactating female, age 2 to 35 years, inclusive as of the day of the Screening Visit. Female subjects of
- •childbearing potential must not be pregnant or breast-feeding. Female subjects of childbearing potential must have a negative urine or serum pregnancy test at screening. Subjects of childbearing or childfathering potential must be willing to use medically acceptable forms of birth control, which includes abstinence, while being treated on this study and for 90 days after the last dose of study drug
- •2. Subject must have a diagnosis of LGS, where seizures that result in drops are not completely controlled by current antiepileptic treatments. (Subjects without a formal diagnosis may still be enrolled at Sponsor discretion if all other criteria are met)
- •3.Subjects must meet all of the following 4 criteria for GLS, as defined in this protocol:
- •a.Onset of seizures at 11 years of age or younger
- •b.Multiple seizure types (must include TS or TA), including countable motor seizures that result in drops. Countable motor seizure types
- •eligible for inclusion are: GTC, TS, CS, AS, FS with observable motor symptoms, and MS that result in a drop
- •c.Abnormal cognitive development
- •d.Evidence of EEG in the medical history that shows abnormal background activity accompanied by slow spike and wave pattern <2.5
- •Hz(Acceptable evidence includes a copy of the EEG trace, EEG report, or physician note that appropriately describes the EEG findings.)
- •4.Subject must have had at least 8 drop seizures in the last 4 weeks prior to Screening (minimum of 4 drop seizures in the first two weeks
- •and 4 in the last two weeks before baseline), by parent/guardian report to Investigator or investigator medical notes
- •5.Receiving at least 1 concomitant AED and up to 4 concomitant AEDs, inclusive. The KD and VNS are permitted but do not count towards the total number of AEDs. Rescue medications for seizures are not counted towards the total number of AEDs
- •6.All medications or interventions for epilepsy (including KD and VNS) must be stable for at least 4 weeks prior to screening and are expected to remain stable throughout the study
- •7.Subject has been informed of the nature of the study and informed consent has been obtained from the legally responsible parent/guardian.
- •8.Subject has provided assent in accordance with Institutional Review Board (IRB)/Ethics Committee requirements, if capable
- •9.Subject's parent/caregiver is willing and able to be compliant with diary completion, visit schedule and study drug accountability
- •Randomization:
- •1.Subject has been approved for study inclusion by the Epilepsy Study Consortium
- •2.Subject does not have an exclusionary cardiovascular or cardiopulmonary abnormality based on ECHO, ECG or physical examination and is approved for entry by the central cardiac reader. Exclusionary abnormalities include, but are not limited to:
- •a.Trace or greater mitral or aortic valve regurgitation in subjects <18 years of age
- •b.Mild or greater mitral or aortic valve regurgitation in subjects >18 years of age
- •c.Possible signs of pulmonary hypertension with abnormal or greater than upper range of normal values
- •d.Evidence of left ventricular dysfunction (systolic or diastolic)
- •3.Subject demonstrates a stable baseline with = 2 seizures per week resulting in drops during the 4-week Baseline Period
- •4.Subject's parent/caregiver has been compliant with diary completion during the Baseline Period, in the opinion
排除标准
- •1. Subject has a known hypersensitivity to fenfluramine or any of the excipients in the study medication.
- •2. Subject’s etiology of seizures is a degenerative neurological disease.
- •3. Subject has a history of hemiclonic seizures in the first year of life.
- •4. Subject only has drop seizures in clusters, where individual seizures cannot be counted reliably.
- •5. Subject has pulmonary arterial hypertension.
- •6. Subject has current or past history of cardiovascular or cerebrovascular disease, such as cardiac valvulopathy, myocardial infarction or stroke, or clinically significant structural cardiac abnormality, including but not limited to mitral valve prolapse, atrial or ventricular septal defects, patent ductus arteriosis (note: Patent Foramen Ovale or a bicuspid valve are not considered exclusionary).
- •7. Subject has current or recent history of Anorexia Nervosa, bulimia, or depression within the prior year that required medical treatment or psychological treatment for a duration greater than 1 month.
- •8. Subject has a current or past history of glaucoma.
- •9. Subject has had an anoxic episode requiring resuscitation within 6 months of the Screening Visit.
- •10. Subject has moderate or severe hepatic impairment. Asymptomatic subjects with mild hepatic impairment (elevated liver enzymes < 3x ULN and/or elevated bilirubin <2x ULN) may be entered into the study after review and approval by the Medical Monitor in conjunction with the sponsor, in consideration of comorbidities and concomitant medications.
- •11. Subject has severe renal impairment (estimated glomerlular filtration rate <30mL/min/1.73m2)
- •12. Subject is receiving concomitant therapy with any of the following: centrally-acting anorectic agents; monoamine-oxidase inhibitors; any centrally-acting compound with clinically appreciable amount of serotonin agonist or antagonist properties, including serotonin reuptake inhibition; other centrally-acting noradrenergic agonists, including atomexetine; or cyproheptadine (see Appendix 1 for a complete list of prohibited medications). (Note: Short-term medication requirements for prohibted medications will be handled on a per case basis by the Medical Monitor.)
- •13. Subject has positive result on urine tetrahydrocannabinol (THC) Panel or whole blood cannabidiol (CBD) at the Screening Visit.
- •14. Subject is taking felbamate for less than 1 year prior to screening and/or does not have stable liver function and hematology laboratory tests, and/or the dose has not been stable for at least 60 days prior to the Screening Visit.
- •15. Subject is known to be human immunodeficiency virus (HIV) positive.
- •16. Subject is known to have active viral hepatitis (B or C)
- •17. Subject is currently receiving an investigational product.
- •18. Subject has participated in another clinical trial within the past 30 days (calculated from that study’s last scheduled visit). Participation in non-treatment trials will be reviewed by the medical monitor.
- •19. Subject is at imminent risk of self-harm or harm to others, in the investigator’s opinion, based on clinical interview and responses provided on the Columbia-Suicide Severity Rating Scale (C-SSRS). Subjects must be excluded if they report suicidal behavior in the past 6 months as measured by the C-SSRS at Screening or Baseline, which includes suicidal ideation with intent and plan (Item #5). If a subject reports suicidal ideation on Item 4 without specific plan, and the investigator feels that the subject is appr
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