[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-cluster-headache\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-cluster-headache":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,66,92],{"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},"100644885","a-first-in-human-study-to-assess-the-initial-safety-tolerability-and-effectiveness-of-the-onss-bilateral-occipital-nerve-field-stimulation-system-for-the-prophylactic-treatment-of-chronic-cluster-headache-in-difficult-to-treat-subjects-100644885",false,"NCT07677137","A First-in-human Study to Assess the Initial Safety, Tolerability, and Effectiveness of the ONSS Bilateral Occipital Nerve Field Stimulation System for the Prophylactic Treatment of Chronic Cluster Headache in Difficult-to-treat Subjects.","A Monocentric, Single-arm, Single-blind Withdrawal First-in-human Study to Assess the Initial Safety, Tolerability, and Effectiveness of the ONSS Bilateral Occipital Nerve Field Stimulation System for the Prophylactic Treatment of Chronic Cluster Headache in Difficult-to-treat Subjects.","ONFIELD","Inclusion Criteria:\n\n1. ICHD-3 criteria for chronic cluster headache\n2. Documented history of CCH since at least 2 years\n3. Minimum mean attack frequency of 4 attacks per week at baseline (-4week to +2 week up to implant)\n4. Documented minimum 4 weeks of retrospective cluster headache diary data\n5. Age range: 22-70 years\n6. Difficult-to-treat CCH with documented previous complete failure, insufficient efficacy, intolerance, or contra-indications to most preventive CH treatments among which are oral steroids or suboccipital infiltrations, verapamil, lithium carbonate and topiramate.\n7. No preventive CH treatment or stable preventive CH medication for ≥ 2 weeks before enrolment.\n\n   Subject agrees not to change existing treatment during the whole duration of the trial.\n8. Participant written informed consent provided before enrolment\n9. Participant willing and capable of subjective evaluation and to fill in an electronic CH diary, to understand questionnaires, and to read, understand and sign the written informed consent form.\n10. Partcipant willing and able to comply with study-related requirements, procedures, and visits.\n\nExclusion Criteria:\n\n1. Other significant neurological, psychiatric, or disabling diseases which in the opinion of the investigator may interfere with the study.\n2. History of epilepsy, current treatment of epilepsy\n3. Documented history of cerebrovascular accident (CVA)\n4. Participants suffering from a substance use disorder, as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria. Recreational use of cannabis is allowed.\n5. Participants at high risk of suicide\u002Fsuicidal ideation in the past one year assessed with the C-SSRS at screening\n6. Having another active implanted device such as a cardiac pacemaker, a spinal cord, peripheral nerve, sphenopalatine ganglion, or deep brain hypothalamic stimulator, and\u002For a drug delivery pump, etc.\n7. Cranial botulinum toxin injections in the past 3 months before enrolment. Administration of the following treatments in the last month before enrolment: monoclonal antibodies blocking calcitonin gene-related peptide transmission, suboccipital infiltrations with steroids and\u002For local anesthetics, oral steroids, radiofrequency procedure or infiltrations of the sphenopalatine ganglion, opioids WHO 3. Oral or systemic steroids are not allowed during the month before enrolment, except low doses (prednisone not superior to 10mg\u002Fday for no more than 7 days) if needed for other disorders.\n8. Medication overuse headache (ICHD 3 8.2)\n9. Inability to fill out an electronic diary.\n10. Previous surgery or trauma involving the cervical spine or the occipital bone\n11. Coagulopathy or required anticoagulant medications that cannot be safely discontinued in the perioperative period.\n12. Concurrent participation in another clinical study\n13. Planned pregnancy, pregnancy, or breastfeeding.","ALL","22 Years","70 Years",{"count":21,"type":22},10,"ESTIMATED","INTERVENTIONAL",[25],"NA","The purpose of this clinical trial is to evaluate the safety and effectiveness of the Occipital Nerve Stimulation System (ONSS) in treating chronic cluster headache in adults.\n\nThe study aims to answer the following questions:\n\n* What adverse events or medical complications occur following ONSS implantation and stimulation?\n* Does treatment with the ONSS reduce the frequency of cluster headache attacks compared with baseline?\n\nParticipant Involvement\n\nParticipants will:\n\n* Undergo implantation of the ONSS device.\n* Use the ONSS for a 48-week treatment period.\n* Attend scheduled clinic visits for follow-up assessments and device evaluations.\n* Maintain a diary documenting cluster headache attacks and use of rescue medications.\n* Complete study-related assessments throughout the study period.",[28],"Chronic Cluster Headache",[30],"Cluster Headaches","RECRUITING","2026-06-29",{"date":34,"type":35},"2026-06-30","ACTUAL",{"date":37,"type":35},"2026-05-18",{"date":39,"type":22},"2027-07",{"name":41,"class":42},"Man and Science, SA","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":43},"100601667","response-to-combined-trigeminal-and-occipital-nerve-stimulation-for-the-preventive-treatment-in-chronic-cluster-headache-100601667","NCT07113470","Response to Combined Trigeminal and Occipital Nerve Stimulation for the Preventive Treatment in Chronic Cluster Headache","Response to Combined Trigeminal and Occipital Nerve Stimulation for the Preventive Treatment in Chronic Cluster Headache: The RESPONSE-II Study","RESPONSE-II","Inclusion Criteria:\n\n1. Able and willing to provide informed consent\n2. 18 years of age or older\n3. Documented Primary Chronic Cluster Headache, for at least 1 year as per ICHD-3 criteria\n\nExclusion Criteria:\n\n1. Any other chronic primary or secondary headache disorder, unless they can clearly differentiate them from cluster headache attacks based on the quality and associated symptoms\n2. Secondary Cluster Headache","18 Years",{"count":21,"type":22},[25],"This is a limited open-label study being performed at two centers in the Netherlands. All participants will receive the same treatment, and both the patients and doctors will know what that treatment is. The goal is to see how safe and effective the PRIMUS system is for preventing Chronic Cluster Headaches (CCH) in people who haven't responded well to the drug verapamil. The study will also look at the patients' experience using the system.",[28],"2026-03-20",{"date":59,"type":35},"2026-03-25",{"date":61,"type":35},"2026-03-17",{"date":63,"type":22},"2028-12-01",{"name":65,"class":42},"Salvia BioElectronics",{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":23,"phases":77,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":4},"100589120","phase-2-efficacy-safety-and-tolerability-of-low-sodium-oxybate-for-nocturnal-cluster-headache-attacks-100589120","NCT06950281","Efficacy, Safety and Tolerability of Low Sodium Oxybate for Nocturnal Cluster Headache Attacks","Low Sodium Oxybate Use for Nocturnal Cluster Headache: Safety, Efficacy and Tolerability of JZP-258 (XYWAV) - a Phase 2 Randomized, Double-Blind, Placebo-Controlled, Bi-center Study.","SUNCET","Inclusion criteria\n\nAge ≥18 and ≤75 at the time of consent.\n\nDiagnosed with chronic cluster headache according to the International Classification of Headache Disorders (ICHD-III) criteria.\n\nFree of other cluster headache prophylactic medication OR on stable dose for at least 4 weeks.\n\nNot having received a GON (Greater Occipital Nerve) injection or oral prednisone in the previous 3 months.\n\nAt least 4 nocturnal cluster headache attacks per week (defined as occurring after sleep onset during the night between 22:00 and 08:00), not exclusively appearing during a single night, but spread across multiple nights.\n\nExclusion criteria\n\nSuspected of having another trigeminal autonomic cephalalgia (TAC).\n\nOther headaches if the patient cannot reliably distinguish them from cluster headache attacks.\n\nWeight at inclusion of \\\u003C50kg or \\>120kg.\n\nSignificant active or unstable psychiatric disease in the opinion of the investigator.\n\nSignificant pulmonary or neuromuscular diseases in the opinion of the investigator.\n\nA history of or current indication of substance abuse or substance use disorder.\n\nUnwillingness to refrain from consuming ≤ 1 alcohol unit per day and not later than 8 pm.\n\nStimulator devices which could influence sleep or cluster headache symptoms, such as an occipital nerve stimulator (ONS), when settings have not been stable for at least three months prior to screening.\n\nParticipation in a clinical trial of an investigation drug or device in the past 30 days.\n\nWomen who are pregnant\u002Fbreastfeeding. Woman of childbearing age need to agree to sufficient contraception during the trial.\n\nContraindications for using LXB:\n\n* Sleep apnoea syndrome or increased apnoea index (AI \\> 15\u002Fh).\n* High risk of sleep apnoea syndrome, indicated by the STOP-Bang questionnaire (score ≥ 5).\n* Currently suffering from severe depression and using medication or receiving cognitive therapy. Final choice is at the discretion of the principal investigator.\n* Porphyria.\n* Succinic semialdehyde dehydrogenase (SSADH-)deficiency.\n* Use of opiates, barbiturates, valproic acid, phenytoin, ethosuximide, tricyclic antidepressants, topiramate, LXB (except for the intervention dose) or sedatives including benzodiazepines during the study. If benzodiazepines are used prior to inclusion, they must be discontinued at least one week before the baseline phase.","75 Years",{"count":76,"type":22},52,[78],"PHASE2","The goal of this clinical trial is to evaluate the efficacy of low sodium oxybate (LXB) (brand name Xywav) in the treatment of (nocturnal) cluster headache attacks in subjects with chronic cluster headache.\n\nIt is an 16 week, randomized, double-blind, placebo- controlled, bi-center trial.\n\nLXB will be administered as a twice nightly regimen. All subjects will undergo an 6 week Treatment Titration and Optimization Phase.\n\nThe main trial endpoint is the change from baseline in average weekly frequency of nocturnal cluster headache attacks over 4-week fixed stable dose of treatment period.",[28],"NOT_YET_RECRUITING","2025-11-19",{"date":84,"type":35},"2025-11-24",{"date":86,"type":22},"2026-01",{"date":88,"type":22},"2028-05",{"name":90,"class":91},"Leiden University Medical Center","OTHER",{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":17,"minAge":100,"maxAge":74,"enrollmentInfo":101,"targetDuration":4,"studyType":23,"phases":103,"briefSummary":104,"conditions":105,"keywords":106,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":118},"100475940","phase-2-lsd-to-improve-cluster-headache-impact-trial-100475940","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","16 Years",{"count":102,"type":22},65,[78],"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.",[28],[107,108],"Chronic cluster headache","Lysergic acid diethylamide","2025-04-10",{"date":111,"type":35},"2025-04-15",{"date":113,"type":22},"2025-04-16",{"date":115,"type":22},"2027-04",{"name":117,"class":91},"Radboud University Medical Center",2]