CTIS2023-508165-33-00进行中（未招募）1 期
An Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of ZYN002 Administered as a Transdermal Gel to Children, Adolescents and Young Adults with Fragile X Syndrome - ZYN2-CL-017
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 210
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
- 0 至 64（—）
- 性别
- All
入选标准
- •Must have completed protocol ZYN2-CL-033., Females of childbearing potential must have a negative pregnancy test at all designated visits., Male or female children and adolescents aged 3 to <23 years, at the time of entry into ZYN2-CL-033., Judged by the Investigator to be in generally good health at entry based upon the results of a medical history, physical examination, 12-lead ECG, and clinical laboratory test results. Laboratory results outside of the reference range must be documented as not clinically significant by both the Investigator and Sponsor., Patients with a history of seizure disorders must currently be receiving treatment with a stable regimen of no more than two AEDs for the four weeks preceding study entry; or must be seizure-free for one year if not currently receiving AEDs., Patients who are taking psychotropic medication(s) should be on a stable regimen of no more than three such medications for at least four weeks preceding study entry. Psychotropic medications include (but are not limited to) antipsychotics, antidepressants, anxiolytics, attention-deficit / hyperactivity disorder (ADHD) medications, and medications for sleep., If patients are receiving non-pharmacological behavioral and/or dietary interventions, they must be stable and have been doing so for three months prior to entry., Patients have a body mass index between 12–30 kg/m2 (inclusive) and patients with a body mass index >30 kg/m2 and <40 kg/m2 with normal liver function laboratory values and with no immediate family history of fatty liver disease., Patients and parents/caregivers agree to abide by all study restrictions and comply with all study procedures, and in the Investigator’s opinion, are reliable and willing and able to comply with all protocol requirements and procedures., Patients and parents/caregivers must be adequately informed of the nature, risks of the study, and give written informed consent prior to enrollment in ZYN2-CL-017.
排除标准
- •Patient is receiving or has received an investigational drug or device less than or equal to 30 days prior to screening, with the exception of ZYN002 or placebo in the previous Zynerba FXS trial, ZYN2-CL-033., History of significant allergic condition, significant drug-related hypersensitivity, or allergic reaction to any compound or chemical class related to ZYN002 or its excipients., Patient has an advanced, severe, or unstable disease that may interfere with the study outcome evaluations., Patient has an acute or progressive neurological disease, psychosis, schizophrenia, or any psychiatric disorder or severe mental abnormalities (other than FXS) that are likely to require changes in drug therapy or interfere with the objectives of the study or the ability to adhere to protocol requirements., Patient has a positive result for the presence of HBsAg, HCV, or HIV antibodies., Patient has known history of cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, cardiac conduction problems, exercise-related cardiac events including syncope and pre-syncope, risk factors for Torsades de pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome), or other serious cardiac problems., Any clinically significant condition or abnormal findings at entry that would, in the opinion of the Investigator, preclude study participation or interfere with the evaluation of the study medication., Any skin disease or condition, including eczema, psoriasis, melanoma, acne, contact dermatitis, scarring, imperfections, lesions, tattoos, or discoloration, that may affect treatment application, application site assessments, or absorption of the trial drug., History of treatment for, or evidence of, drug abuse within the past year., Previous participation in a ZYN002 study (with the exception of patients who completed or did not enter ZYN2-CL-033)., Patient responds yes” to Question ‘4’ or ‘5’ on the C-SSRS (Children) during Screening or at any time on study., Use of cannabis or any THC or CBD-containing product within 3 months of entry or during the study (aside from ZYN002)., Patient has a positive drug screen, including ethanol, cocaine, THC, barbiturates, amphetamines (unless prescribed), benzodiazepines (except midazolam or comparable administered for blood draws and ECG collection), and opiates., Patient is using the following AEDs: clobazam, phenobarbital, ethosuximide, felbamate, carbamazepine, phenytoin, or vigabatrin., Patient is using any strong inhibitor/inducer of CYP3A4 or sensitive substrate for CYP3A4 including but not limited to the following medications: midazolam (except single doses administered for the purposes of obtaining blood samples and ECG’s), oral ketoconazole, fluconazole, nefazadone, rifampin, alfentanil, alfuzosin, amiodarone, cyclosporine, dasatinib, docetaxol, eplerenone, ergotamine, everolimus, fentanyl, halofantrine, irinotecan, lapatinib, levomethadyl, lumefantrine, nilotinib, pimozide, quinidine, ranolazine, sirolimus, tacrolimus, temsirolimus, toremifene, tretinioin, vincristine, vinorelbine, St. John’s Wort, and grapefruit juice/products., Patients may not be taking any benzodiazepines (except single doses administered for the purposes of obtaining blood samples and ECGs) at entry or throughout the study., Patient has an ongoing serious adverse event (SAE) or has experienced an SAE in study ZYN2-C
研究者
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