[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100399249":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":42,"locations":52,"responsibleParty":98,"collaborators":100,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":106,"sex":112,"minAge":113,"maxAge":46,"enrollmentInfo":114,"targetDuration":46,"studyType":117,"phases":118,"briefSummary":120,"conditions":121,"keywords":123,"overallStatus":55,"whyStopped":46,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"Fundación Pública Andaluza para la gestión de la Investigación en Sevilla","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Moderate doses","EXPERIMENTAL","moderate doses of combination therapy applying the minimum average dosage of thiamine and biotin used in patients with BTBGD",[13],"Drug: Moderate doses of Thiamine y Biotin",{"label":15,"type":10,"description":16,"interventionNames":17},"High doses","high doses of the combination therapy applying the average standard dosage of thiamine and biotin used in patients with BTBGD.",[18],"Drug: High doses of Thiamine y Biotin",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Moderate doses of Thiamine y Biotin","Thiamine 600 mg every day + Biotin 150mg every day",[9],[26],"moderate doses of combination therapy",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"High doses of Thiamine y Biotin","Thiamine 1200 mg every day + Biotin 300mg every day",[15],[32],"high doses of the combination therapy",[34,38],{"name":35,"affiliation":36,"role":37},"Pablo Mir Rivera, MD\u002FPhD","Institute of Biomedicine of Seville (IBiS)","STUDY_DIRECTOR",{"name":39,"affiliation":40,"role":41},"Clara M. Rosso Fernández","Virgen del Rocío University Hospital Research and Clinical Trials Unit","PRINCIPAL_INVESTIGATOR",[43,48],{"name":35,"role":44,"phone":45,"phoneExt":46,"email":47},"CONTACT","+34 955923039",null,"pmir@us.es",{"name":49,"role":44,"phone":50,"phoneExt":46,"email":51},"Clara M. Rosso Fernández, MD\u002FPhD","+34 955012144","claram.rosso.sspa@juntadeandalucia.es",[53,72,85],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Hospital Universitario de San Sebastián","RECRUITING","San Sebastián","San Sebastian","20014","Spain","ES",{"type":62,"coordinates":63},"Point",[64,65],-5.9,43.56667,{"lat":65,"lon":64},[68],{"name":69,"role":44,"phone":70,"phoneExt":46,"email":71},"Javier Ruiz Martinez, MD","(0034) 943007027","javier.ruizmartinez@osakidetza.eus",{"facility":73,"status":55,"city":74,"state":74,"zip":75,"country":59,"countryCode":60,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Virgen del Rocío Hospital","Seville","41013",{"type":62,"coordinates":77},[78,79],-5.97317,37.38283,{"lat":79,"lon":78},[82,84],{"name":35,"role":44,"phone":83,"phoneExt":46,"email":47},"+34955923039",{"name":35,"role":41,"phone":46,"phoneExt":46,"email":46},{"facility":86,"status":55,"city":87,"state":46,"zip":46,"country":59,"countryCode":60,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Hospital Ramón y Cajal","Madrid",{"type":62,"coordinates":89},[90,91],-3.70256,40.4165,{"lat":91,"lon":90},[94],{"name":95,"role":44,"phone":96,"phoneExt":46,"email":97},"José Luis López-Sendón, MD","0034 913368013","jlsendonmoreno@salud.madrid.org",{"type":99,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR",[101],{"name":102,"class":103},"Consorcio Centro de Investigación Biomédica en Red (CIBER)","OTHER_GOV","100399249","phase-2-trial-of-the-combined-use-of-thiamine-and-biotin-in-patients-with-huntingtons-disease-100399249",false,"NCT04478734","Trial of the Combined Use of Thiamine and Biotin in Patients With Huntington's Disease","Multicentric Trial on the Use of Combined Therapy of Thiamine and Biotine in Patients With Huntington´s Disease","HUNTIAM","Inclusion Criteria:\n\n* Patients of legal age with manifest Huntington's disease with motor symptoms (chorea, dystonia or bradykinesia) and\u002For neuropsychiatric; and genetic confirmation of a number of repetitions of the cytosine-adenine-guanine trinucleotide (CAG triplet) in the HTT gene (coding for HTT) greater than or equal to 39\n* Patients should be capable of giving informed consent and attending the planned visit of the study.\n* Women of childbearing age should obtain a negative result in the serum or urine pregnancy test at the screening visit. They must also accept the use of appropriate contraceptive methods during the course of the clinical trial and men who have a partner of childbearing age, accept the use of contraceptive methods\n\nExclusion Criteria:\n\n* Medical comorbidities considered clinically significant by the clinical judgment of the investigators.\n* Pregnancy or lactation\n* Patients with HD dependents on the basic routine daily life activities (UHDRS TFC \\\u003C 7) or a severe cognitive decline.\n* Active psychosis at the moment of the screening evaluation.\n* Severe renal failure.\n* Patients previously treated with thiamine and\u002For biotin or enrolled in other HD clinical trial with oligonucleotide antisense (IONIS-HTTRX (RG6042).","ALL","18 Years",{"count":115,"type":116},24,"ESTIMATED","INTERVENTIONAL",[119],"PHASE2","Evaluate the safety and tolerability of combined oral thiamine with biotin therapy in patients with Huntington´s disease in mild to moderate stages and it is intended to evaluate the biological effect of the treatment in the central nervous system of these patients using as the main biomarker the increase in the level of thiamine monophosphate (TMP) in cerebrospinal fluid (CSF) of these patients with Huntington Disease (HD) during a follow-up period of one year.\n\nOur main hypothesis is that combined thiamine-biotin oral therapy is a secure and well-tolerated treatment, potentially capable of modifying the disease course or avoiding the progression of symptoms in early-stages HD patients",[122],"Huntington Disease",[124,125],"thiamine and biotine","combination therapy","2025-02-24",{"date":128,"type":129},"2025-02-25","ACTUAL",{"date":131,"type":129},"2023-04-12",{"date":133,"type":116},"2025-12-30",{"name":5,"class":6},3]