[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Guangzhou Novaken Pharm Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":63},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100605914","phase-2-the-study-is-being-conducted-to-evaluate-the-efficacy-and-safety-of-dexmedetomidine-hydrochloride-microneedles-for-preoperative-sedation-in-children-100605914",false,"NCT07168720","The Study is Being Conducted to Evaluate the Efficacy and Safety of Dexmedetomidine Hydrochloride Microneedles for Preoperative Sedation in Children","Study on Pharmacokinetics and Clinical Efficacy of Dexmedetomidine Hydrochloride Microneedles(DEX) for Preoperative Sedation in Children","Inclusion Criteria:\n\n* Aged 2 years to 6 years (inclusive ), any genders;\n* Body weight meeting the criteria:\n* Scheduled to undergo general anesthesia for surgery\u002Fprocedure\n* American Society of Anesthesiologists（ASA） I\\~II\n* Provide written informed consent from the legal guardian\n\nExclusion Criteria:\n\n* Allergy to any component of the Dexmedetomidine Hydrochloride Microneedle Patch, history of allergy to other sedative drugs, or known allergy to α2-adrenergic receptor-related products or excipients;\n* Having received other sedative-hypnotic or analgesic drugs prior to randomization, where the time since last dose is less than 7 half-lives;\n* History of bronchial asthma, chronic respiratory diseases, or other severe respiratory system diseases;\n* History of neurological diseases such as ischemic encephalopathy encephalopathy, craniocerebral injury, etc., which in the investigator's judgment may affect the evaluation of the investigational product;\n* History of thoracic, cardiac, or brain surgery;\n* Presence of large areas of skin damage or skin conditions unsuitable for topical patch application on the inner aspects of both forearms or the outer aspects of both thighs;\n* Abnormal liver\u002Fkidney function test values (ALT or AST \\>1.5 times the upper limit of normal \\[ULN\\], or bilirubin \\>1.5 × ULN, or serum creatinine \\>1.5 × ULN);\n* Severe cardiovascular diseases (e.g., fulminant myocarditis, high-grade or third-degree atrioventricular block, sick sinus syndrome, severe arrhythmia, cardiomyopathy, severe pulmonary hypertension, pulmonary atresia, heart failure);\n* Anemia requiring treatment, as judged by the investigator (hemoglobin \\\u003C80 g\u002FL);\n* Use of highly selective α2 agonists or antagonists prior to randomization, where the time since last dose is less than 7 half-lives;\n* Participation in another clinical trial (meaning having received an investigational drug or device) within 3 months prior to screening;\n* Presence of severe psychiatric illness at screening leading to inability or unwillingness to cooperate;\n* Other situations deemed by the investigator as unsuitable for inclusion.","ALL","2 Years","6 Years",{"count":20,"type":21},64,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The study is being conducted to evaluate the efficacy, safety and the population pharmacokinetic characteristics of Dexmedetomidine Hydrochloride Microneedles for preoperative sedation in children",[27],"Preoperative Sedation","RECRUITING","2025-09-15",{"date":31,"type":32},"2025-09-19","ACTUAL",{"date":34,"type":32},"2025-08-29",{"date":36,"type":21},"2026-04-30",{"name":38,"class":39},"Guangzhou Novaken Pharm Co., Ltd.","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":62,"locationsCount":40},"100604996","phase-2-the-study-is-being-conducted-to-evaluate-the-safety-and-efficacy-of-xjn010-nasal-spray-in-patients-with-parkinsons-disease-experiencing-off-episodes-100604996","NCT07156773","The Study is Being Conducted to Evaluate the Safety and Efficacy of XJN010 Nasal Spray in Patients With Parkinson's Disease Experiencing Off Episodes","Study on Safety and Clinical Efficacy of XJN010 Nasal Spray in Patients With Parkinson's Disease Experiencing Off Episodes","Inclusion Criteria:\n\n* Male or female patients aged 30 to 85 years (inclusive);\n* Diagnosed with Parkinson's disease according to the Chinese Diagnostic Criteria for Parkinson's Disease (2016), with a disease duration of at least 3 years;\n* Patients with a Hoehn-Yahr stage rating (during \"on\" periods) of 1 to 3;\n* Demonstrates responsiveness to levodopa (≥30% improvement\u002Fdecrease in UPDRS-III score (motor examination) from \"off\" to \"on\" state following morning administration of routine levodopa dose);\n* Patients must have no plans for conception from 2 weeks before the first dose until 1 month after the last dose, no plans to donate sperm, and agree to use highly effective contraception methods;\n* Patients are capable of understanding the study requirements, voluntarily provide written informed consent, and are able to complete the study in compliance with the trial protocol.\n\nExclusion Criteria:\n\n* Individuals with motor impairments that severely affect their ability to participate in and perform study procedures;\n* Those exhibiting dyskinesia that significantly impacts daily functioning;\n* Known hypersensitivity\u002Fallergic reaction or intolerance to any component of the investigational drug;\n* Previous Parkinson's disease (PD) surgery (including but not limited to deep brain stimulation or brain cell transplantation) or planned PD surgery during the trial period;\n* History of malignancy within the past 5 years, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated with radical surgery, or ductal carcinoma in situ of the breast treated with radical surgery;\n* History of severe psychiatric disorders within the past year, such as major depression, mania, schizophrenia, or patients with suicidal tendencies;\n* Patients deemed unsuitable for intranasal administration by the investigator (e.g., severe rhinitis, nasal deformities, etc.);\n* Those currently receiving centrally nervous system-active medications (e.g., sedatives, hypnotics, antidepressants, anxiolytics), except for those who have maintained a stable dose for at least 30 days prior to screening and can remain stable during the study;\n* History of orthostatic hypotension or clinically significant hypotension or orthostatic hypotension identified during screening (orthostatic hypotension is defined as a drop in systolic blood pressure ≥20 mmHg or diastolic blood pressure ≥10 mmHg within 3 minutes of standing from a supine position)\n* Any laboratory test during screening meeting the following criteria:\n\nLiver function: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>3 × upper limit of normal (ULN); or total bilirubin \\>2 × ULN; Renal function: Serum creatinine \\>178 μmol\u002FL;11. Pregnant or lactating females, or those with a positive pregnancy test during screening;\n\n* History of drug or alcohol abuse within the past year;\n* Participation in a clinical trial and use of an investigational drug within 1 month prior to screening or within 5 drug half-lives (whichever is longer);\n* Any other condition considered by the investigator to make the patient unsuitable for participation in the trial.","30 Years","85 Years",{"count":51,"type":21},84,[24],"The study is being conducted to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of XJN010 Nasal Spray in Patients with Parkinson's Disease Experiencing Off Episodes",[55],"Parkinson Disease","2025-09-04",{"date":58,"type":32},"2025-09-05",{"date":60,"type":32},"2025-09-03",{"date":36,"type":21},{"name":38,"class":39},""]