[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618060":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":56,"studyPopulation":44,"armGroups":57,"interventions":70,"overallOfficials":44,"centralContacts":80,"locations":88,"responsibleParty":1128,"collaborators":44,"id":1130,"slug":1131,"hasResults":1132,"nctId":1133,"briefTitle":1134,"officialTitle":1135,"acronym":1136,"eligibilityCriteria":1137,"healthyVolunteers":1132,"sex":1138,"minAge":1139,"maxAge":1140,"enrollmentInfo":1141,"targetDuration":44,"studyType":1144,"phases":1145,"briefSummary":1147,"conditions":1148,"keywords":1150,"overallStatus":91,"whyStopped":44,"lastUpdateSubmitDate":1157,"lastUpdatePostDateStruct":1158,"startDateStruct":1161,"completionDateStruct":1163,"leadSponsor":1165,"locationsCount":1166},{"fullName":5,"class":6},"Novartis","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":44},[9],{"measure":10,"description":11,"timeFrame":12},"Change from Baseline in cUHDRS score","The Composite Unified Huntingtons Disease Ratings Scale (cUHDRS) is an improved composite measure to assess multi-domain clinical progression in HD. The cUHDRS is a combined weighted score of measures of motor function (TMS), cognition (SDMT and SWRT) and overall functional capacity (TFC):\n\ncUHDRS = \\[(TFC-10.4)\u002F1.9 - (TMS-29.7)\u002F14.9 + (SDMT-28.4)\u002F11.3 + (SWRT - 66.1)\u002F20.1\\] + 10.\n\nIn conjunction with one another, these measures provide a comprehensive, sensitive and specific tool for monitoring disease progression, with lower scores indicating more severe disease. cUHDRS score range from -8 to 25.","Baseline, Month 36",[14,17,20,24,27,30,33,37,40],{"measure":15,"description":16,"timeFrame":12},"Change from Baseline in UHDRS-TFC","The UHDRS-Total Functional Capacity (TFC) focuses on the Investigator's assessment of the participant's capacity to perform a range of activities including occupation, finances, self-care, domestic chores and activities of daily living. The responses are derived from interview with the participant and\u002For companion, if applicable. Scores range from 0 to 13, with higher scores representing better functioning.",{"measure":18,"description":19,"timeFrame":12},"Change from Baseline in UHDRS-IS","The UHDRS-Independence Scale (IS) measures a patient's overall level of functional independence in activities of daily living. It provides a single score ranging from 10 (total dependence\u002Fbedbound) to 100 (no special care needed) in intervals of 10, with higher scores indicating better functioning. Scores can also be assigned in increments of 5 for intermediate levels of function.",{"measure":21,"description":22,"timeFrame":23},"The time to decline in TFC score by at least one or IS score by at least 10","The UHDRS-Total Functional Capacity (TFC) focuses on the Investigator's assessment of the participant's capacity to perform a range of activities including occupation, finances, self-care, domestic chores and activities of daily living. The responses are derived from interview with the participant and\u002For companion, if applicable. Scores range from 0 to 13, with higher scores representing better functioning.\n\nThe UHDRS-Independence Scale (IS) measures a patient's overall level of functional independence in activities of daily living. It provides a single score ranging from 10 (total dependence\u002Fbedbound) to 100 (no special care needed) in intervals of 10, with higher scores indicating better functioning. Scores can also be assigned in increments of 5 for intermediate levels of function.","Baseline to end of treatment up to 36 months",{"measure":25,"description":26,"timeFrame":12},"Change from Baseline in UHDRS-TMS","The UHDRS-Total Motor Score (TMS) is the cumulative sum of the individual motor ratings obtained during the administration of the motor assessment portion of the UHDRS. It includes items related to eye movements, speech, limb movements (including hand taps and pronation-supination), dystonia, chorea, and gait\u002Fbalance. Scores range from 0 to 124, with higher scores indicating greater motor impairment.",{"measure":28,"description":29,"timeFrame":12},"Change from Baseline in SDMT","The Symbol Digit Modality Test (SDMT) is used to assess attention, working memory, psychomotor speed and visual perceptual processing. Participants are presented with a translation key of specific numbers paired with unique abstract symbols. Below the translation key is an array of symbols paired with empty spaces, the participant's task is to match the number for each symbol as quickly as possible in a given time frame. Scores are based on number of correctly paired items and range from 0 to 110, with higher scores representing better performance.",{"measure":31,"description":32,"timeFrame":12},"Change from Baseline in SWRT","The Stroop Word Reading Test (SWRT) is a measure of processing and psychomotor speed. Participants are presented with a list or words (color names) printed in black ink and asked to read aloud as many words as possible within a set timeframe. Scores are based on the number of words read correctly and range from 0 to 60, with higher scores representing better performance.",{"measure":34,"description":35,"timeFrame":36},"Percent change from Baseline in blood mHTT protein","The mutant huntington protein (mHTT) which is detectable both in blood and cerebrospinal fluid (CSF), represents a reliable biomarker for HD due to its direct involvement in disease pathology.\n\nBlood mHTT is a direct product of the pathogenic HTT gene mutation and represents a proximal marker of Huntington's disease (HD) biology.","Baseline to steady state and up to 36 months in blood mHTT protein",{"measure":38,"description":39,"timeFrame":12},"Change from Baseline in serum NfL","Serum Neurofilament light chain NfL is a component of the neuronal cytoskeleton, released into CSF and blood after neuro-axonal damage, serving as a marker of neurodegeneration and disease progression in HD.",{"measure":41,"description":42,"timeFrame":43},"Incidence and severity of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and TEAEs leading to participant withdrawal","Number of participants with AEs and SAEs, including notable findings on physical examination, changes in vital signs, laboratory parameters, ECG, etc.","Baseline to up to 36 months",null,{"allocation":46,"interventionModel":47,"interventionModelDescription":44,"primaryPurpose":48,"observationalModel":44,"timePerspective":44,"maskingInfo":49},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":50,"maskingDescription":44,"whoMasked":51},"QUADRUPLE",[52,53,54,55],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","This study will have a variable double-blind treatment duration of up to 36 months. As part of the study design, not every participant will complete 36 months of treatment.\n\nThe study consists of 3 periods:\n\n* Screening Period: A period of up to 42-days to assess participants eligibility\n* Double-blind Treatment Period: This period will have variable individual treatment duration, up to 36 months. The double-blind treatment period concludes when ≥50% patients complete Month 36. The maximum treatment duration for an individual participant is 36 months.\n* Safety Follow-up Period: A period consisting of one safety follow-up visit, conducted on site or by phone call, for all participants not continuing treatment in the separate open-label extension study or discontinuing early. The visit\u002Fphone call will take place 30 days after End of Study (EOS)",[58,64],{"label":59,"type":60,"description":61,"interventionNames":62},"Votoplam","EXPERIMENTAL","Votoplam (blinded) taken orally, randomized in a 3:2 ratio (Votoplam: Placebo)",[63],"Drug: Votoplam (blinded)",{"label":65,"type":66,"description":67,"interventionNames":68},"Placebo","PLACEBO_COMPARATOR","Placebo (blinded) taken orally, randomized in a 3:2 ratio (Votoplam: Placebo)",[69],"Drug: Placebo",[71,78],{"type":72,"name":73,"description":74,"armGroupLabels":75,"otherNames":76},"DRUG","Votoplam (blinded)","Votoplam (blinded) active treatment",[59],[77],"HTT227",{"type":72,"name":65,"description":65,"armGroupLabels":79,"otherNames":44},[65],[81,86],{"name":82,"role":83,"phone":84,"phoneExt":44,"email":85},"Novartis 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7555","harika-anedalkekinagath@uiowa.edu",{"name":310,"role":110,"phone":44,"phoneExt":44,"email":44},"Annie Killoran",{"facility":312,"status":91,"city":313,"state":314,"zip":315,"country":95,"countryCode":96,"cosmosGeoPoint":316,"geoPoint":320,"contacts":321},"University of Kansas Hospital","Fairway","Kansas","66205",{"type":98,"coordinates":317},[318,319],-94.6319,39.02223,{"lat":319,"lon":318},[322,325],{"name":323,"role":83,"phone":44,"phoneExt":44,"email":324},"Cameron Zoraghchi","czoraghchi2@kumc.edu",{"name":326,"role":110,"phone":44,"phoneExt":44,"email":44},"Richard Dubinsky",{"facility":328,"status":91,"city":329,"state":330,"zip":331,"country":95,"countryCode":96,"cosmosGeoPoint":332,"geoPoint":336,"contacts":337},"Beth Israel Deaconess Med Ctr","Boston","Massachusetts","02215",{"type":98,"coordinates":333},[334,335],-71.05977,42.35843,{"lat":335,"lon":334},[338,341],{"name":339,"role":83,"phone":44,"phoneExt":44,"email":340},"Caroline Wolff","cwolff@bidmc.harvard.edu",{"name":342,"role":110,"phone":44,"phoneExt":44,"email":44},"Samuel Arthur Frank",{"facility":344,"status":91,"city":345,"state":346,"zip":347,"country":95,"countryCode":96,"cosmosGeoPoint":348,"geoPoint":352,"contacts":353},"Henry Ford Health System","Detroit","Michigan","48202",{"type":98,"coordinates":349},[350,351],-83.04575,42.33143,{"lat":351,"lon":350},[354,357],{"name":355,"role":83,"phone":44,"phoneExt":44,"email":356},"Blagica Veselinova","bveseli1@hfhs.org",{"name":358,"role":110,"phone":44,"phoneExt":44,"email":44},"Bisena Bulica",{"facility":360,"status":91,"city":361,"state":346,"zip":362,"country":95,"countryCode":96,"cosmosGeoPoint":363,"geoPoint":367,"contacts":368},"Trinity Health Michigan","Grand Rapids","49503",{"type":98,"coordinates":364},[365,366],-85.66809,42.96336,{"lat":366,"lon":365},[369,372],{"name":370,"role":83,"phone":44,"phoneExt":44,"email":371},"Melissa Brown Culbertson","melissa.brown-culbertson@trinity-health.org",{"name":373,"role":110,"phone":44,"phoneExt":44,"email":44},"Danette C Taylor",{"facility":375,"status":91,"city":376,"state":377,"zip":378,"country":95,"countryCode":96,"cosmosGeoPoint":379,"geoPoint":383,"contacts":384},"Albany Medical College","Albany","New York","12208",{"type":98,"coordinates":380},[381,382],-73.75623,42.65258,{"lat":382,"lon":381},[385,389],{"name":386,"role":83,"phone":387,"phoneExt":44,"email":388},"Alicia Leader","+1 518-262-5938","downeya@amc.edu",{"name":390,"role":110,"phone":44,"phoneExt":44,"email":44},"Era Kaur Hanspal",{"facility":392,"status":91,"city":393,"state":377,"zip":394,"country":95,"countryCode":96,"cosmosGeoPoint":395,"geoPoint":399,"contacts":400},"UBMD Neurology","Buffalo","14202",{"type":98,"coordinates":396},[397,398],-78.87837,42.88645,{"lat":398,"lon":397},[401,405],{"name":402,"role":83,"phone":403,"phoneExt":44,"email":404},"Sonia Joseph","+1 716 932 6080","joseph53@buffalo.edu",{"name":406,"role":110,"phone":44,"phoneExt":44,"email":44},"Kelly Andrzejewski",{"facility":408,"status":91,"city":377,"state":377,"zip":409,"country":95,"countryCode":96,"cosmosGeoPoint":410,"geoPoint":414,"contacts":415},"Columbia University Irving Medical","10032",{"type":98,"coordinates":411},[412,413],-74.00597,40.71427,{"lat":413,"lon":412},[416,420],{"name":417,"role":83,"phone":418,"phoneExt":44,"email":419},"Sandra Rizer","+1 212 305 1718","sz2667@cumc.columbia.edu",{"name":421,"role":110,"phone":44,"phoneExt":44,"email":44},"Karen Marder",{"facility":423,"status":91,"city":424,"state":377,"zip":425,"country":95,"countryCode":96,"cosmosGeoPoint":426,"geoPoint":430,"contacts":431},"Universi of Rochester School of Med","Rochester","14609",{"type":98,"coordinates":427},[428,429],-77.61556,43.15478,{"lat":429,"lon":428},[432,436],{"name":433,"role":83,"phone":434,"phoneExt":44,"email":435},"Hannah Mesmer","+1 585 275 6412","hannah_mesmer@urmc.rochester.edu",{"name":437,"role":110,"phone":44,"phoneExt":44,"email":44},"Frederick Marshall",{"facility":439,"status":91,"city":440,"state":441,"zip":442,"country":95,"countryCode":96,"cosmosGeoPoint":443,"geoPoint":447,"contacts":448},"University Of NC At Chapel Hill","Chapel Hill","North Carolina","27599-9500",{"type":98,"coordinates":444},[445,446],-79.05584,35.9132,{"lat":446,"lon":445},[449,452],{"name":450,"role":83,"phone":44,"phoneExt":44,"email":451},"Alexandra Seemungal","Alexandra_Seemungal@med.unc.edu",{"name":453,"role":110,"phone":44,"phoneExt":44,"email":44},"Claudia Testa",{"facility":455,"status":91,"city":456,"state":441,"zip":457,"country":95,"countryCode":96,"cosmosGeoPoint":458,"geoPoint":462,"contacts":463},"Duke University Health System","Durham","27710",{"type":98,"coordinates":459},[460,461],-78.89862,35.99403,{"lat":461,"lon":460},[464,467],{"name":465,"role":83,"phone":44,"phoneExt":44,"email":466},"Lisa Gauger","lisa.gauger@duke.edu",{"name":468,"role":110,"phone":44,"phoneExt":44,"email":44},"Burton Scott",{"facility":470,"status":91,"city":471,"state":472,"zip":473,"country":95,"countryCode":96,"cosmosGeoPoint":474,"geoPoint":478,"contacts":479},"Cleveland Clinic Foundation","Cleveland","Ohio","44195",{"type":98,"coordinates":475},[476,477],-81.69541,41.4995,{"lat":477,"lon":476},[480,484],{"name":481,"role":83,"phone":482,"phoneExt":44,"email":483},"Margaret Andorf","+1 216 442 5232","andorfm@ccf.org",{"name":485,"role":110,"phone":44,"phoneExt":44,"email":44},"Adam Margolius",{"facility":487,"status":91,"city":488,"state":489,"zip":490,"country":95,"countryCode":96,"cosmosGeoPoint":491,"geoPoint":495,"contacts":496},"University of Pennsylvania","Philadelphia","Pennsylvania","19107",{"type":98,"coordinates":492},[493,494],-75.16362,39.95238,{"lat":494,"lon":493},[497,500],{"name":498,"role":83,"phone":44,"phoneExt":44,"email":499},"Gwenivere 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