[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100464211":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":35,"responsibleParty":60,"collaborators":64,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":11,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":37,"whyStopped":11,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Leiden University Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo Arm","PLACEBO_COMPARATOR",null,[13],"Drug: Saline solution",{"label":15,"type":16,"description":11,"interventionNames":17},"Intervention Arm","EXPERIMENTAL",[18],"Drug: Methylprednisolone",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Methylprednisolone","Injection with prednisolon",[15],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Saline solution","0,9%",[9],[30],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Willemijn Naber","CONTACT","0715262587","w.c.naber@lumc.nl",[36,49],{"facility":5,"status":37,"city":38,"state":11,"zip":11,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","Leiden","Netherlands","NL",{"type":42,"coordinates":43},"Point",[44,45],4.49306,52.15833,{"lat":45,"lon":44},[48],{"name":31,"role":32,"phone":11,"phoneExt":11,"email":11},{"facility":50,"status":37,"city":51,"state":11,"zip":11,"country":39,"countryCode":40,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"Canisius Wilhelmina Ziekenhuis","Nijmegen",{"type":42,"coordinates":53},[54,55],5.85278,51.8425,{"lat":55,"lon":54},[58],{"name":59,"role":32,"phone":11,"phoneExt":11,"email":11},"Wim Mulleners",{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Rolf Fronczek","Principal Investigator",[65],{"name":66,"class":6},"ZonMw: The Netherlands Organisation for Health Research and Development","100464211","phase-3-repeated-gon-injections-in-cch-100464211",false,"NCT05324748","Repeated GON Injections in CCH","Repeated Corticosteroid Injections Around the Greater Occipital Nerve (GON) as Prophylactic Treatment in Chronic Cluster Headache","REGON","Inclusion Criteria:\n\n* Age ≥18 and ≤ 70 years\n* Chronic cluster headache (International Classification of Headache Disorders - third edition; ICHD-3)\n* Ictal pain must be always at the same side\n* ≥4 weekly attacks of cluster headache in the prospective one-month baseline observation period\n* On a stable regimen of cluster headache prophylactics for \\>4 weeks prior to onset of study treatment and agreeing not to increase the dose and not starting a new cluster prophylactic during the study period\n\nExclusion Criteria:\n\n* Contra-indication against, or current use of, corticosteroids\n* Occipital nerve stimulation (ONS)\n* Use of anticoagulation medication or a known bleeding disorder\n* Inability to use an electronic diary to monitor individual attacks and other items\n* Other headaches if the patient cannot reliably distinguish them from attacks of cluster headache\n* Current use of prophylactic medication for other headaches\n* Pregnancy","ALL","18 Years","70 Years",{"count":79,"type":80},50,"ESTIMATED","INTERVENTIONAL",[83],"PHASE3","Background:\n\n\\- The effect of repeated GON-injections has never been studied in a double-blind randomized trial as a prophylactic therapy in a well-documented group of chronic patients. As such, (repeated) GON-injection has not yet found its place in current (inter)national treatment protocols for chronic cluster headache.\n\nObjectives:\n\n\\- The primary objective is to determine if repeated GON-injection result in effective control of cluster headache attacks for more days compared to placebo in chronic cluster headache.\n\nEligibility:\n\n\\- Patients will be selected from the LUMC (Leiden University Medical Center) and CWZ (Canisius Wilhelmina Hospital) chronic cluster headache populations, diagnosed based upon the ICHD-3.\n\nDesign:\n\n\\- Bi-centre, randomized, double-blind, placebo-controlled retention trial with a maximum follow-up of one year.",[86],"Cluster Headache",[88],"GON-injection","2025-11-19",{"date":91,"type":92},"2025-11-24","ACTUAL",{"date":94,"type":92},"2022-11-07",{"date":96,"type":80},"2026-06",{"name":5,"class":6},2]