[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658055":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":11,"studyPopulation":11,"armGroups":47,"interventions":58,"overallOfficials":11,"centralContacts":67,"locations":73,"responsibleParty":89,"collaborators":11,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":11,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":11,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":11,"overallStatus":110,"whyStopped":11,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Newleos Therapeutics, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Change in quantitative electroencephalogram (qEEG) beta-band power",null,"Baseline to Week 12",[14,17,20,23,26,28,30,32,34],{"measure":15,"description":16,"timeFrame":12},"Change in Dup15q Clinical global impression of severity (CGI-s) and change (CGI-C)","The Dup15q Syndrome Clinician Global Impression of Severity (Dup15q CGI-S) is a clinician-rated measure of global severity of illness at a given point in time. Each domain scoreranges from 1-6. Higher scores indicate higher severity of illness. The Dup15q Syndrome Clinician Global Impression of Change (Dup15q CGI-C) is a clinician-rated measure assessing the clinician's impression of change in illness compared with baseline. Each domain score ranges from 1-7. Lower scores indicate improved symptoms, and higher scores indicate worsening symptoms.",{"measure":18,"description":19,"timeFrame":12},"Change in Vineland Adaptive Behavior Scales -Third Edition (Vineland-3) subdomain Growth Scale Value (GSV) scores","The Vineland Adaptive Behavior Scales -Third Edition (Vineland-3) measures adaptive behavior in 3 domains: Communication (subdomains Expressive, Reception, and Written), Socialization (subdomains Interpersonal, Play \\& Leisure, Coping Skills), and Daily Living Skills (Personal, Domestic, Community), and also yields an overall Adaptive Behavior Composite score. The domains and the Composite are reported as a standard score (population mean 100; standard deviation 15; range 20-140). The subdomains are reported as v-scale scores (population mean 10, standard deviation 3; range 1-24). Higher scores indicate higher adaptive behavior abilities",{"measure":21,"description":22,"timeFrame":12},"Change in Behavior Assessment System for Children - Third Edition (BASC-3) composite and scale scores","The Behavior Assessment System for Children (BASC-3) assesses behavioral and emotional concerns. It has multiple scales: Externalizing Problems (subscales Hyperactivity, Aggression; Conduct Problems); Internalizing Problems (Anxiety, Depression Somatization); additional subscales of Attention Problems, Atypicality, and Withdrawal, and an overall Behavioral Symptoms Index. Each of these scales and subscales is scored as a T-score (population mean of 50, standard deviation of 10; range 20-120). Higher T-scores indicate greater behavioral challenges.",{"measure":24,"description":25,"timeFrame":12},"Change in Aberrant Behavior Checklist - Second Edition Community Version (ABC-2-C) domain scores","The Aberrant Behavior Checklist (ABC-2-C) domain scores assess challenging behaviors. The domain scores each have different ranges: Irritability from 0-45; Lethargy\u002FSocial Withdrawal 0-48; Stereotypy 0-21; Hyperactivity 0-48; Inappropriate Speech 0-12. Higher scores indicate more severe symptoms.",{"measure":27,"description":11,"timeFrame":12},"Incidence and severity of adverse events (AEs) and severe AEs (SAEs)",{"measure":29,"description":11,"timeFrame":12},"Incidence of treatment discontinuations due to Adverse Events",{"measure":31,"description":11,"timeFrame":12},"Incidence of abnormalities in vital signs, electrocardiograms (ECGs) (PR, QRS, and QT intervals, as well as any other dysrhythmias or abnormal wave), laboratory results (chemistry, hematology and urinalysis), and\u002For physical examination",{"measure":33,"description":11,"timeFrame":12},"Change from baseline in frequency, duration, and type of any seizures as reported in a seizure diary by caregivers",{"measure":35,"description":36,"timeFrame":12},"Treatment-emergent abnormal changes in electroencephalograms","For this safety assessment, electroencephalograms (EEGs) will undergo a typical clinical interpretation by a qualified pediatric epileptologist. Any and all treatment-emergent changes will be recorded.",{"allocation":38,"interventionModel":39,"interventionModelDescription":11,"primaryPurpose":40,"observationalModel":11,"timePerspective":11,"maskingInfo":41},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":42,"maskingDescription":11,"whoMasked":43},"TRIPLE",[44,45,46],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR",[48,53],{"label":49,"type":50,"description":11,"interventionNames":51},"Experimental: NTX-1511","ACTIVE_COMPARATOR",[52],"Drug: Basmisanil",{"label":54,"type":55,"description":11,"interventionNames":56},"Placebo Comparator: Placebo","PLACEBO_COMPARATOR",[57],"Drug: Placebo",[59,64],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":11},"DRUG","Basmisanil","Three times daily (TID) x 12 weeks",[49],{"type":60,"name":65,"description":62,"armGroupLabels":66,"otherNames":11},"Placebo",[54],[68],{"name":69,"role":70,"phone":71,"phoneExt":11,"email":72},"Newleos Therapeutics Clinical Trial Team","CONTACT","978-780-5937","clinicaltrials@newleos.com",[74],{"facility":75,"status":11,"city":76,"state":77,"zip":78,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"NTX-1511 Clinical Study Site","Chicago","Illinois","60612","United States","US",{"type":82,"coordinates":83},"Point",[84,85],-87.65005,41.85003,{"lat":85,"lon":84},[88],{"name":75,"role":70,"phone":71,"phoneExt":11,"email":72},{"type":90,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100658055","phase-2-a-phase-ii-study-of-basmisanil-in-children-and-adolescents-with-dup15q-syndrome-100658055",false,"NCT07846215","A Phase II Study of Basmisanil in Children and Adolescents With Dup15q Syndrome","A Phase II, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety, Efficacy, and Pharmacodynamics of Basmisanil in Participants Aged 2 to 14 Years Old With Dup15q Syndrome","Key Inclusion Criteria:\n\n* Parent, caregiver, or legally authorized representatives has provided written informed consent for the study and is willing to comply with all requirements of the protocol\n* Male or female aged 2 to 14 years inclusive at time of informed consent signature\n* Documented duplication (3 copies) or triplication (4 copies) of the chromosome 15q11.2.-q13.1 (BP2-BP3) segment.\n* Dup15q syndrome Clinician Global Impression of Severity Scale (Dup15q CGI-S) overall severity score ≥ 3 (at least mildly impaired)\n\nKey Exclusion Criteria:\n\n* Pathogenic or likely pathogenic genomic variant outside of the BP2-BP3 segment. Individuals with an isodicentric 15q chromosome and a history of epilepsy\n* Uncontrolled epilepsy (in individuals with interstitial BP2-BP3 duplication or triplication) indicated by: - Use of rescue medication(s) to treat more than one seizure episode or seizure cluster per month, on average in the past 6 months, or -Concomitant chronic use of more than four anti-epileptic medications, or -Status epilepticus within the past 6 months requiring hospitalization for treatment of the status epilepticus, or -Any implanted devices to treat drug-resistant epilepsy\n* Changes to medications within 6-8 weeks prior to screening\n* Changes to non-pharmacological\u002Fbehavioral therapies within 6 weeks prior to screening","ALL","2 Years","14 Years",{"count":102,"type":103},30,"ESTIMATED","INTERVENTIONAL",[106],"PHASE2","The primary goal of this Phase 2 clinical trial is to determine the effects of a selective negative allosteric modulator (NAM) of GABAA α5 receptor, Basmisanil (NTX-1511), on brain wave (EEG) characteristics in children and adolescents with Dup15q syndrome. The main questions this trial aims to answer are:\n\n* How does NTX-1511 affect brain waves (as measured by EEG) in subjects with Dup15q syndrome?\n* Does NTX-1511 impact other developmental features of subjects with Dup15q syndrome?\n\nResearchers will compare the effects of NTX-1511 with matching placebo (look-alike granules that contain no drug).\n\nParticipants will:\n\n* Take NTX-1511 or matching placebo 3 times every day for 12 weeks\n* Visit the clinic 7 times over the course of 23 weeks",[109],"Dup15Q Syndrome","NOT_YET_RECRUITING","2026-09-25",{"date":113,"type":114},"2026-09-29","ACTUAL",{"date":116,"type":103},"2026-12-01",{"date":118,"type":103},"2029-05-01",{"name":5,"class":6},1]