[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100475940":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":42,"responsibleParty":81,"collaborators":83,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":92,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":31,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":45,"whyStopped":31,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Radboud University Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Verum","EXPERIMENTAL","Lysergic diethylamide tartrate (equivalent to 25 microgram LSD base), one dose every 3 days for 3 weeks (totalling 7 vials)",[13],"Drug: LSD tartrate",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo vial looking like verum vial, one vial every 3 days for 3 weeks (totalling 7 vials)",[19],"Drug: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","LSD tartrate","LSD tartrate equivalent to 25 microgram LSD base",[9],[27],"Lysergic acid diethylamide",{"type":22,"name":15,"description":29,"armGroupLabels":30,"otherNames":31},"Placebo with equal appearance",[15],null,[33],{"name":34,"affiliation":5,"role":35},"Kees Kramers, Prof.","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":31,"email":41},"Julia Jansen, MD","CONTACT","+31 24 3658765","julia.jansen@cwz.nl",[43,65],{"facility":44,"status":45,"city":46,"state":31,"zip":31,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Leiden University Medical Center (LUMC)","RECRUITING","Leiden","Netherlands","NL",{"type":50,"coordinates":51},"Point",[52,53],4.49306,52.15833,{"lat":53,"lon":52},[56,60,62],{"name":57,"role":39,"phone":58,"phoneExt":31,"email":59},"Martien van Liefland","071 526 21 11","LICIT@LUMC.nl",{"name":61,"role":35,"phone":31,"phoneExt":31,"email":31},"Rolf Fronczek, MD, PhD",{"name":63,"role":64,"phone":31,"phoneExt":31,"email":31},"Martien van Liefland, MD","SUB_INVESTIGATOR",{"facility":66,"status":45,"city":67,"state":31,"zip":31,"country":47,"countryCode":48,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Canisius-Wilhelmina Ziekenhuis (CWZ)","Nijmegen",{"type":50,"coordinates":69},[70,71],5.85278,51.8425,{"lat":71,"lon":70},[74,78,80],{"name":75,"role":39,"phone":76,"phoneExt":31,"email":77},"Julia Jansen","024 365 82 10","LICIT@cwz.nl",{"name":79,"role":35,"phone":31,"phoneExt":31,"email":31},"Willemijn Leen, MD, PhD",{"name":38,"role":64,"phone":31,"phoneExt":31,"email":31},{"type":82,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[84,86,88],{"name":85,"class":6},"ZonMw: The Netherlands Organisation for Health Research and Development",{"name":87,"class":6},"Canisius-Wilhelmina Hospital",{"name":89,"class":6},"Leiden University Medical Center","100475940","phase-2-lsd-to-improve-cluster-headache-impact-trial-100475940",false,"NCT05477459","LSD to Improve Cluster Headache Impact Trial","Efficacy and Safety of Minidosing Lysergic Acid Diethylamide (LSD) for Chronic Cluster Headache: a Randomized Placebo-controlled Study","LICIT","Inclusion Criteria:\n\n* CCH according to the International Classification of Headache Disorders version 3 (ICHD-3)\n* At screening: stable weekly attack frequency in the 4 weeks prior to screening (assessed retrospectively), averaging at least 8 per week and each week within a 40% window around the average\n* At randomization: average of at least 8 attacks per week and no absence of attacks on more than two consecutive days during baseline\n\nExclusion Criteria:\n\n* Use of excluded concomitant treatment at screening (lithium; other prophylactics if not on a stable dose for less than one month; steroids\u002FGON block within 2 months before screening; sphenopalatinum block, neurostimulation (changed setting within 3 months before screening) or botulinum toxin within 3 months before screening) and during the double-blind phase\n* Use of LSD(-derivatives) (other than investigational drug), psilocybin, ketamine or cannabis within 3 months prior to screening and throughout the study\n* Lifetime and\u002For family history (first degree relatives) of psychotic or bipolar disorder, suicidal intention or attempt\n* A score of 6 or more on the 'Ervaringenlijst' (PQ-16) to exclude subclinical susceptibility to psychosis\n* Actual abuse of alcohol and\u002For recreational drugs\n* Lifetime history of cardiac valvular disease\n* History or evidence of cognitive disorder at screening\n* Positive urine drug screen at screening\n* Females: Pregnancy, lactation, no acceptable contraceptive use","ALL","16 Years","75 Years",{"count":102,"type":103},65,"ESTIMATED","INTERVENTIONAL",[106],"PHASE2","This study aims to investigate the efficacy and safety of LSD 25μg every 3 days for 3 weeks versus placebo in the treatment of chronic cluster headache (cCH).\n\nIt is a 3-week double-blind placebo-controlled intervention study, preceded by a 4-week baseline observation period and followed by a 5-week post-treatment observation period.\n\nPrimary objective: to evaluate the efficacy of LSD 25μg every 3 days for 3 weeks in cCH.\n\nAdditional objectives:\n\n* To evaluate the safety of LSD 25μg every 3 days for 3 weeks in cCH.\n* To explore the exposure-response relationship of 25μg LSD in cCH.\n* To explore cost-effectiveness of treatment with LSD in cCH.\n* To evaluate the efficacy of LSD on health-related quality of life.",[109],"Chronic Cluster Headache",[111,27],"Chronic cluster headache","2025-04-10",{"date":114,"type":115},"2025-04-15","ACTUAL",{"date":117,"type":103},"2025-04-16",{"date":119,"type":103},"2027-04",{"name":5,"class":6},2]