[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602918":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":19,"locations":11,"responsibleParty":24,"collaborators":11,"id":26,"slug":27,"hasResults":28,"nctId":29,"briefTitle":30,"officialTitle":31,"acronym":11,"eligibilityCriteria":32,"healthyVolunteers":28,"sex":33,"minAge":34,"maxAge":35,"enrollmentInfo":36,"targetDuration":11,"studyType":39,"phases":40,"briefSummary":42,"conditions":43,"keywords":11,"overallStatus":45,"whyStopped":11,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":11},{"fullName":5,"class":6},"Lumos Pharma","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"LUM-201","EXPERIMENTAL",null,[13],"Drug: LUM-201",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DRUG","1.6 mg\u002Fkg\u002Fday, administered orally once daily",[9],[20],{"name":5,"role":21,"phone":22,"phoneExt":11,"email":23},"CONTACT","515-598-2921","clinical.trials@lumos-pharma.com",{"type":25,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100602918","phase-3-phase-3-long-term-safety-extension-study-of-lum-201-in-children-with-growth-hormone-deficiency-100602918",false,"NCT07129759","Phase 3 Long Term Safety Extension Study of LUM-201 in Children With Growth Hormone Deficiency","A Long-term Extension Study to Evaluate the Safety and Tolerability of Daily Oral LUM-201 in Children With Growth Hormone Deficiency (GHD)","Inclusion Criteria:\n\n* Parent\u002Fcaregiver must be willing to provide written informed consent, and the subject must sign the assent, as applicable.\n* Subject must have successfully completed 12 months of participation in the LUM-201 Phase 3 GHD trial, and be eligible for continuation of treatment, pending all other enrollment criteria are met.\n* Subject who is sexually active must use an acceptable form of contraception.\n* Subject must be eligible for the Day 1 visit as confirmed by the Investigator.\n\nExclusion Criteria:\n\n* Subject has a medical or genetic condition that, in the opinion of the Investigator and\u002For MMs, adds unwarranted risk to use of LUM-201.\n* Pregnancy.\n* Subject has planned or is receiving current long-term treatment with medications known to prolong the QT interval or act as substrates, inducers, or inhibitors of the cytochrome system cytochrome P450 type 3A4 that metabolizes LUM-201 (see Appendix 6 for list of example medications). Subjects receiving shorter-term (two weeks or less) treatment with these medications should be evaluated on case-by-case basis by the Investigator in consultation with the MMs.","ALL","4 Years","12 Years",{"count":37,"type":38},150,"ESTIMATED","INTERVENTIONAL",[41],"PHASE3","This is a Multi-national Trial. The Goal of the Trial is to Offer Subjects Who Complete 12 Months in the LUM-201-10 Phase 3 Trial up to an Additional 36 Months of Treatment of LUM-201 While Evaluating Safety and Tolerability of LUM-201.",[44],"Growth Hormone Deficiency (GHD)","NOT_YET_RECRUITING","2025-08-15",{"date":48,"type":49},"2025-08-19","ACTUAL",{"date":51,"type":38},"2026-09",{"date":53,"type":38},"2030-02",{"name":5,"class":6}]