[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"eds\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:eds":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100645025","phase-3-a-phase-3-efficacy-and-safety-study-of-hbs-301-in-participants-with-narcolepsy-100645025",false,"NCT07675135","A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy","A Phase 3, Randomized, Double-blind, Placebo-Controlled, Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy Followed by an Open-label Extension","Inclusion Criteria:\n\n* Has a current documented diagnosis of NT1 or NT2 per the International Classification of Sleep Disorders, Third Edition (ICSD-3) or the ICSD-3 Text Revision (ICSD-3-TR) within the last 10 years.\n* Has EDS.\n* If taking a permitted chronic concomitant medication or supplement, including nonprohibited antidepressants or wake-promoting agents, must be on a stable dose for at least 3 months prior to Screening and agree to continue at that stable dose for the Double-blind Treatment Period of the study. As needed (PRN) use of any treatment that could affect daytime sleepiness (including but not limited to oxybates, stimulants, modafinil, and armodafinil) is not permitted.\n\nExclusion Criteria:\n\n* Has hypersomnia due to another medical disorder.\n* Has a history of pitolisant use within 5 half-lives prior to Screening.\n* Has a primary diagnosis of psychiatric illness, including depression, that is not well controlled (i.e., symptoms and medications have not been stable for at least 3 months prior to Screening).\n* Has any history of bipolar disorder or psychosis\n* Has acute or chronic liver disease or a history of moderate or severe hepatic impairment.\n* Has a body surface area-corrected estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin.\n* Has a known history of long QT syndrome or serious abnormality of the electrocardiogram (ECG).","ALL","18 Years",{"count":19,"type":20},258,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled clinical study to assess the efficacy and safety of HBS-301 in treating excessive daytime sleepiness (EDS), cataplexy, sleepiness\u002Fwakefulness, and fatigue in adult participants (ages ≥18 years) with narcolepsy.",[26,27,28,29],"EDS","Cataplexy","Fatigue","Narcolepsy",[31,32,33,26,34,35],"pitolisant","HBS-301","narcolepsy","cataplexy","fatigue","RECRUITING","2026-06-25",{"date":39,"type":40},"2026-06-30","ACTUAL",{"date":42,"type":40},"2026-06-04",{"date":44,"type":20},"2027-11",{"name":46,"class":47},"Harmony Biosciences Management, Inc.","INDUSTRY",14,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":75,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":104},"100590462","registry-and-natural-history-of-epilepsy-dyskinesia-syndromes-100590462","NCT06967727","Registry and Natural History of Epilepsy-Dyskinesia Syndromes","Inclusion Criteria:\n\n* Having at least one pathogenic or likely pathogenic variant in one of the genes of interest:\n\nAARS2, ADCY5, ALG13, AP3B2, AP4B1, AP4E1, AP4M1, AP4S1, ARX, ATP1A3, CACNA1A, CACNA1E, CACNA2D2, CDKL5, CSTB, DARS2, DLAT, DLD, DNM1, EARS2, EPG5, EPM2A, FARS2, FOXG1, FRRS1L, GABRA1, GABRA2, GABRB2, GABRB3, GABRG2, GNAO1, GRIA2, GRIA4, GRIN1, GRIN2A, GRIN2B, GRIN2D, HARS2, HNRNPU, HTT, IQSEC2, IRF2BPL, KCNA2, KCNB1, KCNC1, KCNMA1, KCNQ2, KCNQ3, KCNT1, LARS2, MECP2, MEF2C, MTND5, MTTK, MTTL1, NARS2, NHLRC1, PCDH12, PCDH19, PDE10A, PDE2, PDHA1, PDHB, PDHX, PDK3, PDP1, PIGA, PIGN, PIGP, PIGQ, PIGS, PLCB1, POLG, PRRT2, PURA, RHOBTB2, SCN1A, SCN1B, SCN2A, SCN8A, SCN9A, SETBP1, SETD5, SLC13A5, SLC1A2, SLC25A22, SLC2A1, SMC1A, SNX14, SPTAN1, ST3GAL3, STXBP1, SYNGAP1, SYNJ1, SZT2, TARS2, TBC1D24, UBA5, UBE3A, VAMP2, VARS2, WARS2, WDR45, WWOX, YIF1B, YWHAG, and other genes associated with epilepsy-dyskinesia syndromes.\n\nExclusion Criteria:\n\n* Not having a pathogenic or likely pathogenic variants in the genes of interest","0 Years","30 Years",{"count":58,"type":20},700,"OBSERVATIONAL","The Registry and Natural History of Epilepsy-Dyskinesia Syndromes is focused on gathering longitudinal clinical data as well as biological samples (blood, urine, and\u002For skin\u002Ftissue) from male and female patients, of all ages, who have a genetic diagnosis of epilepsy-dyskinesia syndromes. Through prospective review and molecular data analysis, the study aims to identify patterns and correlations between movement and seizure disorders, uncovering genotype-phenotype relationships. The initiative's goals are to enhance understanding of epilepsy-dyskinesia syndromes, inform precision medicine approaches, and foster international collaboration.",[62,63,64,26,65,66,67,68,69,70,71,72,73,74],"Epilepsy-Dyskinesia","Epilepsy","Dyskinesia","Epilepsy-Dyskinesia Syndomes","Epilepsy in Children","Dyskinesias","Movement Disorders in Children","Neurologic Disorder","Chorea","Myoclonus","Ataxia","Dystonia Disorder","Movement Disorders",[76,62,77,64,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93],"epilepsy","Epilepsy-Dyskinesia Syndrome","movement disorders","epileptic encephalopathy","neurogenetics","PRRT2","ATP1A3","GNAO1","MECP2","CACNA1A","CDKL5","FOXG1","SCN1A","SCN8A","SLC2A1","STXBP1","UBA5","ADCY5","2025-08-15",{"date":96,"type":40},"2025-08-17",{"date":98,"type":40},"2025-06-01",{"date":100,"type":20},"2030-07",{"name":102,"class":103},"Boston Children's Hospital","OTHER",1]