[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"EG 427\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":65},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100561909","phase-1-dose-escalation-study-of-eg110a-administered-by-intradetrusor-injections-to-adults-with-neurogenic-detrusor-overactivity-related-incontinence-following-spinal-cord-injury-who-regularly-perform-clean-intermittent-catheterization-100561909",false,"NCT06596291","Dose Escalation Study of EG110A, Administered by Intradetrusor Injections to Adults With Neurogenic Detrusor Overactivity-related Incontinence Following Spinal Cord Injury Who Regularly Perform Clean Intermittent Catheterization","First-In-Human Phase 1b\u002F2a Dose Escalation Study of EG110A, Administered by Intradetrusor Injections to Adult Participants With Neurogenic Detrusor Overactivity-related Incontinence Following Spinal Cord Injury Who Regularly Perform Clean Intermittent Catheterization","Main Inclusion Criteria:\n\n1. Participant has stable supra-sacral traumatic SCI with American Spinal Injury Association (ASIA) Impairment Scale grade A, B, C, D or E which occurred at least 12 months before Screening.\n2. Participant has UI due to urodynamically-confirmed NDO for at least 3 months prior to Screening.\n3. Participant has:\n\n   1. been treated for NDO for at least 3 months prior to Screening with an adequate course of oral pharmacotherapy(ies) and\u002For has had intolerable side-effects and\u002For exhibited an inadequate response in the opinion of the investigator and participant, i.e., at least 8 UI episodes in a week despite consistent use of the therapy. Participant does not wish to proceed to BoNT\u002FA treatment, and their next step would be surgical intervention.\n\n      OR\n   2. had an inadequate response to BoNT\u002FA treatment in the opinion of the investigator and participant, i.e., at least 8 UI episodes in a week, and the last BoNT\u002FA treatment for their NDO was at least 6 months prior to screening. Treatment with BoNT\u002FA was not started more than 7 years ago, and their next step would be surgical intervention.\n\nMain Exclusion Criteria:\n\n1. Participant has previous or current tumor or malignancy affecting the spinal column or spinal cord, or any other nonstable cause of SCI.\n2. Participant with active oral or genital herpes lesion. If the participant has an active oral or genital herpes infection this needs to be treated and healed first. The participant may be rescreened once the lesion has fully healed (at least 4 weeks after the lesion has healed).\n3. Participant had cancer therapy or radiotherapy ≤ 4 weeks prior to Screening and has toxicities\u002FAEs attributable to previously administered cancer therapies that have not resolved or stabilized.","ALL","18 Years","75 Years",{"count":20,"type":21},16,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This is a first-in-human, Phase 1b\u002F2a, open-label, dose-escalation study of a single treatment course consisting of multiple intradetrusor injections of EG110A in male and female adult participants with Neurogenic Detrusor Overactivity (NDO)-related incontinence following Spinal Cord Injury (SCI), who have persistent incontinence after standard of care therapy and who perform Clear Intermittent Catheterization (CIC) on a regular basis.",[28,29],"Neurogenic Detrusor Overactivity","Spinal Cord Injuries","RECRUITING","2026-02-03",{"date":33,"type":34},"2026-02-05","ACTUAL",{"date":36,"type":34},"2025-01-08",{"date":38,"type":21},"2027-06",{"name":40,"class":41},"EG 427","INDUSTRY",4,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":42},"100610415","phase-1-long-term-follow-up-study-of-patients-who-received-eg110a-a-non-replicative-herpes-simplex-virus-1-derived-gene-therapy-100610415","NCT07227285","Long-term Follow-up Study of Patients Who Received EG110A, a Non-replicative Herpes Simplex Virus 1-derived Gene Therapy","Long-term Follow-up Study of Patients Who Received EG110A, a Non-replicative Herpes Simplex Virus 1-derived Gene Therapy Expressing a Transgene Encoding the Light Chain of Botulinum Toxin F","Inclusion Criteria:\n\n\\- All participants who received at least one dose\u002Finjection of EG110A in Study EG110A-001-01 and have prematurely discontinued or completed that study.\n\nExclusion Criteria:\n\n* Participant plans to participate in another investigational gene therapy study\n* Participant has an uncontrolled intercurrent illness, any disorder, or current substance abuse that would limit compliance with study requirements in the opinion of the investigator",{"count":20,"type":21},[24,25],"The aim of this study is to continue following participants who have received EG110A during five years to know how it is tolerated in humans, any side-effects it may cause and what might be an effective dose over five years. All participants who have received at least one dose\u002Finjection of EG110A in a previous clinical study of EG110A will be asked to roll-over to this long-term follow-up study upon either early discontinuation from, or completion of, that study.",[54,55],"Urinary Bladder, Overactive","Spinal Cord Injury","NOT_YET_RECRUITING","2025-11-10",{"date":59,"type":34},"2025-11-12",{"date":61,"type":21},"2026-04",{"date":63,"type":21},"2031-04",{"name":40,"class":41},""]