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MD",{"facility":748,"status":91,"city":749,"state":733,"zip":750,"country":57,"countryCode":58,"cosmosGeoPoint":751,"geoPoint":755,"contacts":756},"Southwest Family Medicine","Dallas","75235",{"type":60,"coordinates":752},[753,754],-96.80667,32.78306,{"lat":754,"lon":753},[757,761],{"name":758,"role":44,"phone":759,"phoneExt":36,"email":760},"Safia Shaikh","(469) 893-1242","sshaikh@swmedicalgroup.com",{"name":762,"role":72,"phone":36,"phoneExt":36,"email":36},"Chrisette Dharma, MD",{"facility":764,"status":91,"city":765,"state":733,"zip":766,"country":57,"countryCode":58,"cosmosGeoPoint":767,"geoPoint":771,"contacts":772},"Sleep Therapy & Research Center","San Antonio","78229",{"type":60,"coordinates":768},[769,770],-98.49363,29.42412,{"lat":770,"lon":769},[773,777],{"name":774,"role":44,"phone":775,"phoneExt":36,"email":776},"Erin Marshall","(210) 614-6000","marshall.erin@sleeptrc.com",{"name":778,"role":72,"phone":36,"phoneExt":36,"email":36},"Nagwa Lamaie, MD",{"facility":780,"status":53,"city":765,"state":733,"zip":781,"country":57,"countryCode":58,"cosmosGeoPoint":782,"geoPoint":784,"contacts":785},"HasResearch","78240",{"type":60,"coordinates":783},[769,770],{"lat":770,"lon":769},[786,790],{"name":787,"role":44,"phone":788,"phoneExt":36,"email":789},"Kimberly Rosales","(210) 614-7711","kimberly.rosales@hasresearch.com",{"name":791,"role":72,"phone":36,"phoneExt":36,"email":36},"Hernan Salazar, DO",{"facility":793,"status":91,"city":794,"state":733,"zip":795,"country":57,"countryCode":58,"cosmosGeoPoint":796,"geoPoint":800,"contacts":801},"Tricoastal Narcolepsy and Sleep Disorders Center","Sugar Land","77478",{"type":60,"coordinates":797},[798,799],-95.63495,29.61968,{"lat":799,"lon":798},[802,806],{"name":803,"role":44,"phone":804,"phoneExt":36,"email":805},"Natalia Dubock","(832) 210-3850","research@tricoastalsleep.com",{"name":807,"role":72,"phone":36,"phoneExt":36,"email":36},"Gerry Meskill, 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PhD",{"facility":843,"status":53,"city":844,"state":845,"zip":846,"country":57,"countryCode":58,"cosmosGeoPoint":847,"geoPoint":851,"contacts":852},"West Virginia University Hospital","Morgantown","West Virginia","26506",{"type":60,"coordinates":848},[849,850],-79.9559,39.62953,{"lat":850,"lon":849},[853,857],{"name":854,"role":44,"phone":855,"phoneExt":36,"email":856},"Lauren Chase","304-598-4000","lauren.chase@wvumedicine.org",{"name":858,"role":72,"phone":36,"phoneExt":36,"email":36},"Mouhannad Azzouz, MD",{"facility":860,"status":53,"city":861,"state":862,"zip":863,"country":57,"countryCode":58,"cosmosGeoPoint":864,"geoPoint":868,"contacts":869},"University of Wisconsin-Madison","Madison","Wisconsin","53719",{"type":60,"coordinates":865},[866,867],-89.40123,43.07305,{"lat":867,"lon":866},[870,874],{"name":871,"role":44,"phone":872,"phoneExt":36,"email":873},"Ahmad Allen","(608) 232-3333","aallen45@wisc.edu",{"name":875,"role":72,"phone":36,"phoneExt":36,"email":36},"David Plante, MD, PhD",{"type":877,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","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":888,"type":889},258,"ESTIMATED","INTERVENTIONAL",[892],"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.",[895,896,897,898],"EDS","Cataplexy","Fatigue","Narcolepsy",[900,26,901,895,902,903],"pitolisant","narcolepsy","cataplexy","fatigue","2026-08-10",{"date":906,"type":907},"2026-08-12","ACTUAL",{"date":909,"type":907},"2026-06-04",{"date":911,"type":889},"2027-11",{"name":5,"class":6},50]