[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100407741":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":35,"responsibleParty":75,"collaborators":24,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":24,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":24,"overallStatus":97,"whyStopped":24,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Department of Medical Services Ministry of Public Health of Thailand","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"abobotulinum toxin A","EXPERIMENTAL","Abobotulinum Toxin Type A (Dysport) dose was investigated:\n\ndose: 100 units ( various units each site depend on clinical )",[13],"Drug: Injection botulinum toxin A ( Dysport 100 unit or Neuronox 33.33 unit)",{"label":15,"type":10,"description":16,"interventionNames":17},"neubotulinum toxin A","Neubotulinum Toxin Type A (Neuronox) dose was investigated:\n\ndose: 33.33 units ( various units each site depend on clinical )",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Injection botulinum toxin A ( Dysport 100 unit or Neuronox 33.33 unit)","injection of toxin on facial muscle",[9,15],null,[26,31],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"subsai kongsaengdao, M.D.","CONTACT","+66818180890","skhongsa@gmail.com",{"name":32,"role":28,"phone":33,"phoneExt":24,"email":34},"Arkhom arayawichanon, M.D.","+66816653741","aarayawi@gmail.com",[36,48,57,66],{"facility":37,"status":24,"city":38,"state":24,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":24},"Rajavithi Hospital","Bangkok","10400","Thailand","TH",{"type":43,"coordinates":44},"Point",[45,46],100.50144,13.75398,{"lat":46,"lon":45},{"facility":49,"status":24,"city":50,"state":24,"zip":51,"country":40,"countryCode":41,"cosmosGeoPoint":52,"geoPoint":56,"contacts":24},"Lampang Hospital","Lampang","52000",{"type":43,"coordinates":53},[54,55],99.49277,18.29232,{"lat":55,"lon":54},{"facility":58,"status":24,"city":59,"state":24,"zip":60,"country":40,"countryCode":41,"cosmosGeoPoint":61,"geoPoint":65,"contacts":24},"Surat Thani hospital","Surat Thani","84000",{"type":43,"coordinates":62},[63,64],99.33311,9.14011,{"lat":64,"lon":63},{"facility":67,"status":24,"city":68,"state":24,"zip":69,"country":40,"countryCode":41,"cosmosGeoPoint":70,"geoPoint":74,"contacts":24},"Sappasitthiprasong Hospital","Ubon Ratchathani","34000",{"type":43,"coordinates":71},[72,73],104.84866,15.23844,{"lat":73,"lon":72},{"type":76,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100407741","phase-3-study-of-abobotulinum-toxin-versus-neubotulinum-toxin-injection-for-hemifacial-spasm-in-thai-patients-100407741",false,"NCT04589364","Study of Abobotulinum Toxin Versus Neubotulinum Toxin Injection For Hemifacial Spasm in Thai Patients","A 50-Week Prospective, Double-Blinded, Randomized, Cross-over Design in Multicenter Study of100 Unit of Abobotulinum Toxin Type A (Dysport®) Versus 33.33 Unit of Neubotulinum Toxin Type A (Neuronox®) Injection for Hemifacial Spasm in Thai Patients","DNHFS","The subjects need to satisfy the following criteria before being allowed to participate ni the study:\n\n1. Volunteers with hemifacial spasm aged 18 to 80 years who may or may not have received Botulinum toxin before.\n2. Subjects were diagnosed with hemifacial spasm by a neurologist.\n3. Healthy female volunteers of reproductive age must obtain informed consent from the study physician to avoid pregnancy throughout the study by using condoms or an appropriate method of birth control. too Female volunteers will be required to consent ot a urine pregnancy test before entering the study and throughout the study. There will be a pregnancy test using a urine test strip every time fi menstruation is over.\n4. Volunteers must be evaluated for reliability ni participating ni the research project and volunteers or relatives can record treatment results. and side effects or drugs used in treatment They are willing to participate in the research project and understand the benefits of participating in the study.\n5. The patient has had other normal physical examinations and si able ot undergo a neurological examination as wel as Able ot participate ni physical examinations ot assess symptoms of hemifacial spasm and can cooperate ni completing the AIMS questionnaire, HFS30, 36-item quality of life questionnaire, PHQ9, and the CES-D depression questionnaire.\n\nExclusion Criteria Criteria for exclusion from the study Patients cannot participate in the research project fi they have the following conditions:\n\n1. The volunteer is pregnant or breastfeeding, or the volunteer si a woman at risk of pregnancy who has not received adequate pregnancy protection.\n2. Volunteers who have contraindications or precautions for injection. Botulinum toxin Aor hte need ot use drugs that may cause adverse reactions from Interactions between required drugs and investigational drugs such as aminoglycoside, spectinomycin, polymyxin tetracycline, and lincomycin antibiotics and tubocurarines muscle relaxant.\n3. The volunteer has an allergic reaction to hte drug or any substance related to the drug used for treatment.\n4. The volunteer is unable or unwilling to participate and follow al details in the research project. or not cooperating in completing questionnaires in the research project.\n5. The subject has received any other unregistered drugs or other experimental drugs within the past 6 months. Al types of botulinum toxin are allowed (patients can receive previous treatment with any type of botulinum toxin for more than 14 weeks or 98 The day before the Ist appointment).\n6. Volunteers who have been previously selected for this research project.\n7. Subjects with a history of botulism or co-morbidities such as neuromuscular junction disease such as myasthenia gravis. or Eaton Lumber Syndrome.\n8. Volunteers with other physical diseases or other neurological diseases or psychiatric disorders that may affect treatment. For example, having a history of blood clotting disorders (INR greater than 1.2), low blood platelets. Rheumatoid joint pain, heart attack, coronary artery disease Dementia Any type of psychosis or any other condition or risk factor for adverse reactions that may affect the results of the research.\n9. The volunteer has a history of being addicted to or using drugs or narcotics or has a history of allergic reaction to botulinum toxin.\n10. Subjects who received planned and treated surgery. throughout the research study period or patients receiving aminoglycosides or culale cannot participate in the research","ALL","18 Years","80 Years",{"count":89,"type":90},120,"ESTIMATED","INTERVENTIONAL",[93],"PHASE3","A 50-Week Prospective, Double-Blinded, Randomized, Cross-over design in Multicenter Study of 100 unit of Abobotulinum Toxin Type A (Dysport®) versus 33.33 unit of Neubotulinum Toxin Type A (Neuronox®) Injection for Hemifacial Spasm in Thai Patients, designed gor comparing the effectiveness of Total intensity score after 4. 12. 16 and 24 weeks of treatment and to compare the long-term safety of the injections. Abobotulinum toxin A (Dysport \\*) dose 100 units compared ot neubotulinum toxin A injection (Neuronox \u002F Neuronox®) dose 33.33 units. that it si non-inferiority (non-inferiority) ni the treatment of hemifacial spasm after administration of the drug ni the 0, 12\" ,26\", and 38\" weeks ni the treatment of patients with hemi facial spasm, with a wash out period of 2 weeks between treatments. By proving the non-inferiority of Total intensity score at ,4 ,8 and12 week after treatment which calculated by severity score and duration of facial muscle spasm (hour per day)., as well as severity score and duration of functional impairment (hour per day) recorded for 4,8, and 21 weeks after each treatment between 33.33 unit of Neubotulinum Toxin Type A(Neuronox\\*) and 100 unit of Abobotulinum Toxin Type A (Dysport\\*)",[96],"Hemifacial Spasm","NOT_YET_RECRUITING","2024-04-25",{"date":100,"type":101},"2024-04-26","ACTUAL",{"date":103,"type":90},"2024-05-01",{"date":105,"type":90},"2026-08-01",{"name":5,"class":6},4]