[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582383":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":34,"locations":43,"responsibleParty":113,"collaborators":11,"id":117,"slug":118,"hasResults":119,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":119,"sex":125,"minAge":126,"maxAge":127,"enrollmentInfo":128,"targetDuration":11,"studyType":131,"phases":132,"briefSummary":135,"conditions":136,"keywords":11,"overallStatus":46,"whyStopped":11,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"Nagoya University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Mexiletine group","ACTIVE_COMPARATOR",null,[13],"Drug: Mexiletine hydrochloride",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo group","PLACEBO_COMPARATOR",[18],"Other: Placebo",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Mexiletine hydrochloride","Mexiletine hydrochloride 300 mg is administered orally divided into three times a day after meals for 12 weeks.",[9],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Placebo","Placebo is administered orally divided into three times a day after meals for 12 weeks.",[15],[30],{"name":31,"affiliation":32,"role":33},"Masahisa Katsuno, PhD, MD","Nagoya University Hospital","PRINCIPAL_INVESTIGATOR",[35,39],{"name":31,"role":36,"phone":37,"phoneExt":11,"email":38},"CONTACT","+81527442389","katsuno.masahisa.i1@f.mail.nagoya-u.ac.jp",{"name":40,"role":36,"phone":41,"phoneExt":11,"email":42},"Shinobu Shimizu, PhD","+81527442942","shimizu.shinobu.w3@f.mail.nagoya-u.ac.jp",[44,61,74,87,100],{"facility":45,"status":46,"city":47,"state":11,"zip":11,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Tokyo University Hospital","RECRUITING","Bunkyō City","Japan","JP",{"type":51,"coordinates":52},"Point",[53,54],139.4217,35.5331,{"lat":54,"lon":53},[57],{"name":58,"role":36,"phone":59,"phoneExt":11,"email":60},"Tomotaka Yamamoto, PhD, MD","+81338155411","yamatyama@gmail.com",{"facility":62,"status":46,"city":63,"state":11,"zip":11,"country":48,"countryCode":49,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Chiba University Hospital","Chiba",{"type":51,"coordinates":65},[66,67],140.11667,35.6,{"lat":67,"lon":66},[70],{"name":71,"role":36,"phone":72,"phoneExt":11,"email":73},"Kazumoto Shibuya, PhD, MD","+81432227171","kazumoto@net.email.ne.jp",{"facility":75,"status":46,"city":76,"state":11,"zip":11,"country":48,"countryCode":49,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Hokkaido University Hospital","Sapporo",{"type":51,"coordinates":78},[79,80],141.35,43.06667,{"lat":80,"lon":79},[83],{"name":84,"role":36,"phone":85,"phoneExt":11,"email":86},"Ichiro Yabe, PhD, MD","+81117161161","yabe@med.hokudai.ac.jp",{"facility":88,"status":46,"city":89,"state":11,"zip":11,"country":48,"countryCode":49,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Jichi Medical University Hospital","Shimotsuke",{"type":51,"coordinates":91},[92,93],139.86622,36.41323,{"lat":93,"lon":92},[96],{"name":97,"role":36,"phone":98,"phoneExt":11,"email":99},"Mitsuya Morita, PhD, MD","+81285442111","morita@jichi.ac.jp",{"facility":101,"status":46,"city":102,"state":11,"zip":11,"country":48,"countryCode":49,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Osaka University Hospital","Suita",{"type":51,"coordinates":104},[105,106],135.51567,34.76143,{"lat":106,"lon":105},[109],{"name":110,"role":36,"phone":111,"phoneExt":11,"email":112},"Seiichi Nagano, PhD, MD","+81668795111","nagano@neurol.med.osaka-u.ac.jp",{"type":114,"investigatorFullName":115,"investigatorTitle":116,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Masahisa Katsuno","Professor","100582383","phase-2-clinical-trial-of-mexiletine-hydrochloride-for-spinal-and-bulbar-muscular-atrophy-100582383",false,"NCT06862596","Clinical Trial of Mexiletine Hydrochloride for Spinal and Bulbar Muscular Atrophy","A Multicenter, Randomized, Placebo-controlled, Double-blind Clinical Trial: The Efficacy and Safety of Mexiletine Hydrochloride for Amelioration of Motor Dysfunction in Spinal and Bulbar Muscular Atrophy","Med-SBMA","Inclusion Criteria:\n\n1. Male patients with a CAG repeat count of 38 or more for the androgen receptor gene in genetic testing and a confirmed diagnosis of SBMA\n2. Patients with muscle weakness (limb weakness and atrophy, or bulbar palsy) due to lower motor neuron lesion\n3. Patients with a total ALSFRS-R score of ≥ 24 and ≤ 42 at screening\n4. Patients who are at least 18 years old and less than 80 years old at the time of consent\n5. Patients who give their voluntary written consent after having received adequate information on this study (However, if the patient is unable to sign the consent form due to the condition of the disease, a person equivalent to a regal representative must be present to provide written explanation, the prospective candidate must verbally consent to participate in the study, and a person equivalent to a regal representative must sign the consent form on behalf of the patient. The person who is to be the regal representative may sign the document on his\u002Fher behalf, noting the circumstances and his\u002Fher relationship to the subject.)\n\nExclusion Criteria:\n\n1. Patients who have participated or are participating in a clinical trial within 12 weeks prior to enrollment\n2. Patients with a history of hypersensitivity to any component of this drug product\n3. Patients with a conduction disturbance (such as second- or third-degree atrioventricular block without a pacemaker, or left bundle branch block)\n4. Patients with Brugada-type ECG\n5. Patients with severe heart failure or heart disease (myocardial infarction, valvular disease, cardiomyopathy, etc.)\n6. Patients with sinus bradycardia (\\\u003C50 beats\u002Fminute)\n7. Patients with systolic blood pressure of 90 mmHg or less\n8. Patients with serum potassium level less than 3.5 mmol\u002FL\n9. Patients on antiarrhythmic drugs\n10. Patients on antiepileptic drugs that affect to sodium channels\n11. Patients on theophylline\n12. Patients on narcotics\n13. Patients who used Mexiletine within 1 month prior to enrollment or used Mexiletine for expectations of improvement in symptoms of SBMA\n14. Patients with serious complications\n15. Patients who cannot agree to use contraception during the study period\n16. Other Patients deemed inappropriate by the investigator or subinvestigator","MALE","18 Years","80 Years",{"count":129,"type":130},68,"ESTIMATED","INTERVENTIONAL",[133,134],"PHASE2","PHASE3","The purpose of this clinical trial is to evaluate the efficacy and safety of mexiletine hydrochloride in patients with spinal and bulbar muscular atrophy.\n\nThe main questions it aims to answer are:\n\nDoes mexiletine hydrochloride improve the ALSFRS-R score in spinal and bulbar muscular atrophy patients?\n\nParticipants will:\n\nTake mexiletine hydrochloride or a placebo every day for 3 months Visit the hospital once every 4 weeks for evaluations.",[137],"Spinal and Bulbar Muscular Atrophy","2025-04-11",{"date":140,"type":141},"2025-04-16","ACTUAL",{"date":143,"type":141},"2025-02-28",{"date":145,"type":130},"2027-12-31",{"name":115,"class":6},5]