[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100542053":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":28,"locations":36,"responsibleParty":64,"collaborators":67,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":23,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":23,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":23,"overallStatus":39,"whyStopped":23,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Rigshospitalet, Denmark","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"LNAA supplementation, Then Low-Phe diet","EXPERIMENTAL","Phase 1: LNAA Treatment Period (8 weeks) Each participant will be prescribed a specific dosage of LNAA tablets to be taken three times daily.\n\nPhase 2: Washout (2 weeks) Participants will follow a liberalized diet and refrain from taking any LNAA or amino acid supplement.\n\nPhase 3: Low-Phe diet (8 weeks) Each participant will follow a low-phenylalanine diet. LNAA therapy will not be administered during this phase.",[13],"Other: PreKUnil® LNAA Medical Food for PKU",{"label":15,"type":10,"description":16,"interventionNames":17},"Low-Phe diet, Then LNAA supplementation","Phase 1: Low-Phe diet (8 weeks) Each participant will follow a low-phenylalanine diet. LNAA therapy will not be administered during this phase.\n\nPhase 2: Washout (2 weeks) Participants will follow a liberalized diet and refrain from taking any LNAA or amino acid supplement.\n\nPhase 3: LNAA Treatment Period (8 weeks) Each participant will be prescribed a specific dosage of LNAA tablets to be taken three times daily.",[13],[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"PreKUnil® LNAA Medical Food for PKU","PreKUnil® LNAA Medical Food for PKU is a commercially available active LNAA treatment product for PKU.",[9,15],null,[25],{"name":26,"affiliation":5,"role":27},"Allan Lund, Professor, MD, DMSc","PRINCIPAL_INVESTIGATOR",[29,33],{"name":26,"role":30,"phone":31,"phoneExt":23,"email":32},"CONTACT","+4535451303","allan.lund@regionh.dk",{"name":34,"role":30,"phone":23,"phoneExt":23,"email":35},"Olivia Fjellbirkeland, MD","olivia.welle.fjellbirkeland@regionh.dk",[37,55],{"facility":38,"status":39,"city":40,"state":23,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Center for Inherited Metabolic Diseases","RECRUITING","Copenhagen","2300","Denmark","DK",{"type":45,"coordinates":46},"Point",[47,48],12.56553,55.67594,{"lat":48,"lon":47},[51],{"name":52,"role":30,"phone":53,"phoneExt":23,"email":54},"Olivia Fjellbirkeland","40552002","Fjell.olivia@outlook.com",{"facility":56,"status":57,"city":40,"state":23,"zip":23,"country":42,"countryCode":43,"cosmosGeoPoint":58,"geoPoint":60,"contacts":61},"Copenhagen University Hospital, Rigshospitalet","NOT_YET_RECRUITING",{"type":45,"coordinates":59},[47,48],{"lat":48,"lon":47},[62],{"name":63,"role":30,"phone":23,"phoneExt":23,"email":35},"Olivia Welle Fjellbirkeland, MD",{"type":27,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Allan Meldgaard Lund","Professor, MD, DMSc",[68],{"name":69,"class":70},"Prekulab Ltd ApS","UNKNOWN","100542053","effect-of-large-neutral-amino-acids-in-adults-with-classical-phenylketonuria-100542053",false,"NCT06337864","Effect of Large Neutral Amino Acids in Adults With Classical Phenylketonuria","Safety and Efficacy of Treatment With Large Neutral Amino Acids in Patients With Classical Phenylketonuria","Patients ≥ 18 years of age with Classical PKU molecularly confirmed via the finding of two pathogenic variants in the phenylalanine hydroxylase (PAH) gene and\u002For historical evidence of Phe concentrations ≥1200 μmol\u002FL in the medical history\n\nInclusion Criteria:\n\n* Treatment initiation within the first month of life\n* Intelligence quotient over 84, based upon the baseline neuropsychological evaluation\n* Conventional dietary treatment up to minimum 15 years of age\n* Signed informed consent\n* Willing and able to comply with the protocol and study procedures\n\nExclusion Criteria:\n\n* Unable or unwilling to adhere to the requirements of the study\n* A female who is pregnant or breastfeeding or planning to get pregnant during the study period\n* Concomitant medication that may interfere with the PET analysis, as judged by the investigator\n* A serious neuropsychiatric disease that could interfere with the subject's ability to participate in the study at the discretion of the investigator\n* Concomitant treatment with BH4 supplementation (sapropterin) or Pegvaliase-pqpz (PALYNZIQ)\n* Failing to submit at least one blood Phe home sample during the year before study initiation\n* Standard MRI contraindications\n* Body weight over 110 kg",true,"ALL","18 Years","50 Years",{"count":83,"type":84},30,"ESTIMATED","INTERVENTIONAL",[87],"NA","The overall aim of this study is to evaluate LNAA treatment as a potential alternative to conventional dietary treatment for PKU. This study investigates the effects of LNAA treatment compared to the classic dietary treatment on cerebral dopamine synthesis in patients with classic PKU. We will assess LNAAs effectiveness on neurotransmitter synthesis, cognitive function, mental health, and safety, compared to the standard diet.",[90,91,92,93,94,95,96,97],"Brain Diseases","Brain Diseases, Metabolic","Brain Diseases, Metabolic, Inborn","Genetic Diseases, Inborn","Metabolism, Inborn Errors","Amino Acid Metabolism, Inborn Errors","Metabolic Disease","Phenylketonurias","2025-04-02",{"date":100,"type":101},"2025-04-06","ACTUAL",{"date":103,"type":101},"2024-11-01",{"date":105,"type":84},"2026-09-30",{"name":5,"class":6},2]