[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cdkl5\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cdkl5":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100550560","targeting-the-gut-to-improve-seizure-control-in-cdkl5-deficiency-disorder-cdd-100550560",false,"NCT06448663","Targeting the Gut to Improve Seizure Control in CDKL5 Deficiency Disorder (CDD)","Targeting the Gut to Improve Seizure Control in CDD","NUTRIENT","Inclusion Criteria:\n\nclinical diagnosis of CDD and demonstrated CDKL5 pathogenic variant; drug-resistant seizures; ensured participation of a caregiver; willingness to sign the informed consent.\n\nExclusion Criteria:\n\norganic GI disorders (i.e., food allergies, celiac disease); special diets; percutaneous endoscopic gastrostomy tube; use of antibiotics or probiotics in the previous month.","ALL","3 Years","50 Years",{"count":21,"type":22},20,"ESTIMATED","INTERVENTIONAL",[25],"NA","Standard anti-seizure medications have limited efficacy in seizure control in cyclin-dependent kinase-like 5 deficiency disorder (CDD).\n\nThe study will investigate whether targeting the gut-microbiota-brain axis in CDD patients can alleviate seizures and ameliorate other comorbidities.",[28],"CDKL5",[30],"epilepsy, gut microbiota, sleep disorders","RECRUITING","2024-06-03",{"date":34,"type":35},"2024-06-07","ACTUAL",{"date":37,"type":35},"2024-04-01",{"date":39,"type":22},"2025-04-30",{"name":41,"class":42},"University of Milan","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100482157","international-cdkl5-clinical-research-network-100482157","NCT05558371","International CDKL5 Clinical Research Network","Multi-Site Validation of Biomarkers and Core Clinical Outcome Measures for Clinical Trials Readiness in CDKL5 Deficiency Disorder","ICCRN","Inclusion Criteria:\n\n* All children diagnosed with CDD age 1-month to 100 years of age that are receiving care at one of the study institutions or are registered with the International CDKL5 Disorder Database will be considered for the study population.\n\nExclusion Criteria:\n\n* Individuals who do not meet study inclusion criteria.","1 Month","100 Years",{"count":55,"type":22},1000,"OBSERVATIONAL","Pathogenic variants in the Cyclin-dependent kinase like 5 (CDKL5) gene cause CDKL5 deficiency disorder (CDD, MIM 300672, 105830), a severe developmental and epileptic encephalopathy associated with cognitive and motor impairments and cortical visual impairment. While capability for disease modifying therapies is accelerating, there is a critical barrier for clinical trial readiness that may result in failure of these therapies, not due to lack of efficacy but due to lack of validated outcome measures and biomarkers. The measures and biomarkers validated here will be adaptable to other developmental and epileptic encephalopathies.",[28,59,60],"CDKL5 Deficiency Disorder","CDD","2023-12-05",{"date":63,"type":35},"2023-12-06",{"date":65,"type":35},"2021-02-15",{"date":67,"type":22},"2027-02-15",{"name":69,"class":42},"University of Colorado, Denver",9]