[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582666":3},{"organization":4,"outcomesModule":7,"designInfo":47,"detailedDescription":59,"studyPopulation":50,"armGroups":60,"interventions":71,"overallOfficials":86,"centralContacts":91,"locations":97,"responsibleParty":155,"collaborators":157,"id":161,"slug":50,"hasResults":162,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":166,"eligibilityCriteria":167,"healthyVolunteers":162,"sex":168,"minAge":169,"maxAge":170,"enrollmentInfo":171,"targetDuration":50,"studyType":174,"phases":175,"briefSummary":177,"conditions":178,"keywords":180,"overallStatus":121,"whyStopped":50,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":191},{"fullName":5,"class":6},"Children's Hospital of Orange County","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":39},[9],{"measure":10,"description":11,"timeFrame":12},"Primary Efficacy Endpoint - Vineland-3 Socialization Domain","The primary efficacy endpoint will be the change in standard score on the Socialization Domain of the Comprehensive Interview Form of the Vineland Adaptive Behavior Scale Third Edition (Vineland-3), which includes subdomains for coping skills, play skills, and interpersonal relation skills.","Change from Screening to Week 8 (before washout) will be compared to change from Week 16 to Week 24 (after washout).",[14,18,21,24,27,30,33,36],{"measure":15,"description":16,"timeFrame":17},"Secondary Efficacy Endpoint - Vineland-3, Additional Scores","Vineland-3 Composite Score, Communication Domain Score, and Daily Living Skills Domain Score will also be assessed.","Secondary outcome measures will be used to assess change from Week 0 to Week 8 (before washout) and from Week 16 to Week 24 (after washout).",{"measure":19,"description":20,"timeFrame":17},"Secondary Efficacy Endpoint - Global Impresssion, Severity\u002FChange","Clinician Global Impression of Severity and Change, and Caregiver\u002FParent Global Impression of Severity and Change, will be collected and assessed weighted for socialization.",{"measure":22,"description":23,"timeFrame":17},"Secondary Efficacy Endpoint - Social Responsiveness Scale-2","The Social Responsiveness Scale-2 (SRS-2) is a well-established tool to evaluate socialization that was also used in a prior pilot study.",{"measure":25,"description":26,"timeFrame":17},"Secondary Efficacy Endpoint - Aberrant Behavior Checklist, Second Edition (ABC-2)","The ABC-2 provides measures of repetitive behaviors and includes domains of irritability, social withdrawal, stereotypy, hyperactivity, and inappropriate speech.",{"measure":28,"description":29,"timeFrame":17},"Secondary Efficacy Endpoint - Childhood Sleep Habits Questionnaire (CSHQ)","As a large proportion of the adolescents with ASD population is highly impacted by sleep concerns, the CSHQ will be administered to investigate relationships between KZ101 and sleep.",{"measure":31,"description":32,"timeFrame":17},"Secondary Efficacy Endpoint - Parenting Stress Impact (PSI)","Data from the PSI will be used to evaluate whether changes in symptoms in the ASD participant is associated with changes in parental stress throughout the study.",{"measure":34,"description":35,"timeFrame":17},"Secondary Efficacy Endpoint - Child Behavior Check List (CBCL)","The CBCL is a parental measure of internalizing and externalizing behaviors as well as common DSM-5 conditions co-occurring with ASD.",{"measure":37,"description":38,"timeFrame":17},"Secondary Efficacy Endpoint - Ohio State University Autism Rating Scale, 5th Edition","The Ohio State University Autism Rating Scale 5 (OARS-5) will provide three summary scores to be evaluated with KZ101 administration and placebo administration: autism symptom count, weighted mean severity score of autism symptoms, and impairment index based on level of support needed.",[40,44],{"measure":41,"description":42,"timeFrame":43},"Pharmacokinetic (PK) Endpoints: Cmax","Blood samples for measurement of KZ101 concentration in plasma will be collected and used to identify Peak Plasma Concentration (Cmax).","PK samples will be taken at week 0, 2, 4, 6, 8 (period 1); and 16, 18, 20, 22, 24, 26 (period 2 and follow up).",{"measure":45,"description":46,"timeFrame":43},"Pharmacokinetic (PK) Endpoints: Area Under the Curve (AUC)","Blood samples for measurement of KZ101 concentration in plasma will be collected, and area under the plasma concentration versus time curve (AUC) will be determined.",{"allocation":48,"interventionModel":49,"interventionModelDescription":50,"primaryPurpose":51,"observationalModel":50,"timePerspective":50,"maskingInfo":52},"RANDOMIZED","CROSSOVER",null,"TREATMENT",{"masking":53,"maskingDescription":50,"whoMasked":54},"QUADRUPLE",[55,56,57,58],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","After up to a 4-week screening period, participants will undergo 8 weeks of active or placebo treatment (Period 1), followed by an 8-week washout period, and then cross over to 8 weeks of placebo or active treatment (Period 2). Patients will be followed for 2 weeks after completion of Period 2. Two dosing groups are designated as Group A, who are randomly assigned to active treatment with KZ101 in Period 1 and saline in Period 2, and Group B, who are randomly assigned to saline infusion in Period 1 and active treatment with KZ101 in Period 2. Dosing in both periods will consist of 2 IV infusions of either saline (placebo) or KZ101 (active treatment), given 4 weeks apart.",[61,67],{"label":62,"type":63,"description":50,"interventionNames":64},"Drug followed by Placebo","EXPERIMENTAL",[65,66],"Drug: KZ101","Drug: Placebo",{"label":68,"type":69,"description":50,"interventionNames":70},"Placebo followed by Drug","PLACEBO_COMPARATOR",[65,66],[72,80],{"type":73,"name":74,"description":75,"armGroupLabels":76,"otherNames":77},"DRUG","KZ101","For active treatment with KZ101, a loading dose of 454 mg\u002Fm2 (salt-free) will be followed by a treatment dose of 363 mg\u002Fm2 (salt-free).",[62,68],[78,79],"Suramin","Suramin sodium",{"type":73,"name":81,"description":82,"armGroupLabels":83,"otherNames":84},"Placebo","Dosing in the placebo group will consist of a volume of normal saline equivalent to that given during the active treatment period for each participant.",[62,68],[85],"Saline",[87],{"name":88,"affiliation":89,"role":90},"Aram Kim, MD","Thompson Autism and Neurodevelopmental Center, Children's Hospital of Orange County","PRINCIPAL_INVESTIGATOR",[92],{"name":93,"role":94,"phone":95,"phoneExt":50,"email":96},"Adrienne Moore, PhD","CONTACT","714-288-7456","adrienne.moore@choc.org",[98,119,134],{"facility":99,"status":100,"city":101,"state":102,"zip":103,"country":104,"countryCode":105,"cosmosGeoPoint":106,"geoPoint":111,"contacts":112},"Southwest Autism Research and Resource Center","NOT_YET_RECRUITING","Phoenix","Arizona","85006","United States","US",{"type":107,"coordinates":108},"Point",[109,110],-112.07404,33.44838,{"lat":110,"lon":109},[113,117],{"name":114,"role":94,"phone":115,"phoneExt":50,"email":116},"Padmaja Lakamsani","602-340-8717","PLakamsani@autismcenter.org",{"name":118,"role":90,"phone":50,"phoneExt":50,"email":50},"Christopher J Smith, PhD",{"facility":120,"status":121,"city":122,"state":123,"zip":124,"country":104,"countryCode":105,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Children's Hospital Orange County, Thompson Autism and Neurodevelopmental Center","RECRUITING","Orange","California","92868",{"type":107,"coordinates":126},[127,128],-117.85311,33.78779,{"lat":128,"lon":127},[131,133],{"name":132,"role":94,"phone":95,"phoneExt":50,"email":96},"Adrienne R Moore, PhD",{"name":88,"role":90,"phone":50,"phoneExt":50,"email":50},{"facility":135,"status":121,"city":136,"state":137,"zip":138,"country":104,"countryCode":105,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"Kennedy Krieger Institute","Baltimore","Maryland","21205",{"type":107,"coordinates":140},[141,142],-76.61219,39.29038,{"lat":142,"lon":141},[145,149,153],{"name":146,"role":94,"phone":147,"phoneExt":50,"email":148},"Katie Kay","443-923-3819","kayk@kennedykrieger.org",{"name":150,"role":94,"phone":151,"phoneExt":50,"email":152},"Karen Chen","667-205-4393","chenk@kennedykrieger.org",{"name":154,"role":90,"phone":50,"phoneExt":50,"email":50},"Stephanie Morris, MD",{"type":156,"investigatorFullName":50,"investigatorTitle":50,"investigatorAffiliation":50,"oldNameTitle":50,"oldOrganization":50},"SPONSOR",[158],{"name":159,"class":160},"Kuzani Pharmaceuticals, Inc.","INDUSTRY","100582666",false,"NCT06866275","Suramin for the Treatment of Autism Trial: KZ101 in a Male Pediatric Population With Autism Spectrum Disorder (ASD)","Suramin for the Treatment of Autism Trial (STAT): A Randomized, Double Blind, Crossover Trial of KZ101 in a Male Pediatric Population With Autism Spectrum Disorder","STAT-2A","Inclusion Criteria:\n\n\\- Subject must meet all of the following criteria to be enrolled in this study.\n\n1. Male, aged 5-14 years\n2. Clinical diagnosis of ASD by DSM-5 criteria\n3. ADOS-2 ≥ 7 on the comparison score for Modules 2-4 (completed within the last 2 years).\n4. CGI-S ≥ 4 for socialization specific symptoms of ASD\n5. Leiter-3 non-verbal IQ \\> 70\n6. Standard score \\\u003C 75 on the Socialization Domain of the Comprehensive Interview Form of the Vineland Adaptive Behavior Scale Third Edition\n7. Subjects who are sexually active or potentially sexually active agree to use condoms with a spermicidal as a barrier method of contraception during the treatment period and for at least 30 days after the last dose of study medication\n8. Subjects agree to wear sunscreen and to wear skin covering to the maximal degree tolerated by the child for the duration of the treatment period and for at least 30 days after the last dose of study medication\n9. Subjects must have a ≤ 90 minutes car ride from the study site\n10. English-speaking child and parent\u002Fguardian or caregiver\n11. Parent or their legal guardians must be willing to sign informed consent\n\nExclusion Criteria:\n\n* Subjects who meet any of the following criteria will be excluded from the study.\n\n  1. ASD diagnosis with underlying syndromic diagnosis (e.g., Fragile X, Angelman, Down's Syndrome, etc.)\n  2. ≤ 5th percentile for weight\n  3. Unable to tolerate venipuncture or urine collection\n  4. Acute infection (e.g., upper respiratory tract infection, common cold, flu, strep, COVID-19)\n  5. Severe co-morbid conditions (e.g., psychosis, seizures\u002Fepilepsy uncontrolled by medication, presence of severe visual or hearing impairment) that may interact with study procedures. Controlled epilepsy is allowed providing there has not been a breakthrough seizure in the past year.\n  6. Any organ system dysfunction, especially liver (e.g., ALT or AST ≥ 1.5x the upper limit of normal), kidney (estimated glomerular filtration rate or eGFR \\\u003C 90 mL\u002Fmin\u002F1.73 m2; hematuria confirmed by urine microscopy \\[ \\> 5 red blood cells\u002Fhigh power field\\]; proteinuria \\[\\> 1+ that does not resolve on repeat testing or urine protein to creatinine ratio \\> 0.3\\]; and\u002For presence of any granular, mixed cellular, red blood cell, white blood cell, or muddy brown casts on urine microscopy), or clinically relevant heart or adrenal abnormalities\n  7. Hospitalization within the previous 2 months from screening\n  8. Initiation or change in pharmacotherapy within previous 2 months from screening\n  9. Initiation or change in psychosocial interventions (formal behavioral, cognitive, or cognitive-behavior therapy) within previous 2 months from screening\n  10. Plan to initiate or change pharmacotherapy or psychosocial interventions during the study\n  11. Taking prescription medication that may interact adversely with KZ101 or expose the subject to increased risk of harm such as medications with plasma bound substances including sulfonamides, chlorpromazine, and anti-coagulants\n  12. Currently enrolled in another clinical study or has received any investigational treatment within 30 days of screening\n  13. Taking \\> 3 medications addressing behavioral symptoms related to ASD (ie typical\u002Fatypical antipsychotics and alpha-adrenergic agonists) or comorbid medical conditions such as ADHD, anxiety, or depression. Anti-seizure medications and other medications not related to neurobehavioral symptoms do not count towards the total number of medications allowed.\n  14. History of serious dermatological reactions\n  15. History of allergy, intolerance, or photosensitivity to any drug\n  16. Unable or unwilling to adhere to study requirements","MALE","5 Years","14 Years",{"count":172,"type":173},45,"ESTIMATED","INTERVENTIONAL",[176],"PHASE2","Suramin has been found to correct the symptoms, metabolism, and brain synaptic abnormalities in two classical genetic and environmental mouse models of autism. A preliminary clinical trial (SAT-1) examined the safety and activity of a single low-dose of suramin in children with ASD and concluded suramin showed promise as a novel approach to treatment of ASD. The current study, STAT-2A, will be a randomized, double-blind, crossover, 30-week study to evaluate the preliminary proof of concept, safety, and PK of suramin sodium (KZ101) with repeat dosing by IV infusion in males 5-14 years of age who have been diagnosed with ASD. The study will be conducted at approximately 3 sites contributing approximately 15 subjects per site. Total enrollment of approximately 45 subjects is planned to achieve approximately 36 participants completing the study.",[179],"Autism Spectrum Disorder (ASD)",[78,181],"suramin sodium","2026-01-05",{"date":184,"type":185},"2026-01-07","ACTUAL",{"date":187,"type":185},"2025-04-09",{"date":189,"type":173},"2028-04",{"name":5,"class":6},3]