[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07598708":3,"trial-entities:NCT07598708":229,"trial-summary:NCT07598708":235},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":43,"primary_purpose":44,"phases":45,"enrollment_info":48,"interventions":51,"primary_outcomes":67,"secondary_outcomes":71,"sex":100,"minimum_age":101,"maximum_age":102,"healthy_volunteers":15,"eligibility_criteria":103,"std_ages":114,"locations":117,"central_contacts":220,"overall_officials":226,"references":227,"see_also_links":228},"NCT07598708","ORX750-004","A Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence","A Randomized, Double-blind, 3-Arm Parallel Design Study to Investigate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Cleminorexton Compared With Placebo in Participants With Central Disorders of Hypersomnolence","RECRUITING","2027-12-31","2026-07","2026-08-11","2026-05-29","Centessa Pharmaceuticals (UK) Limited","INDUSTRY",false,"Narcolepsy Type 1 (NT1) and Narcolepsy Type 2 (NT2) are rare conditions that make people feel very sleepy during the day (often referred to as excessive daytime sleepiness \\[EDS\\]). People living with these conditions might find it hard to stay alert and pay attention when they are at school, working, driving, or performing other daily activities.\n\nWhile all conditions result in feeling sleepy, there are some differences in other common symptoms:\n\n* NT1: People with NT1 often feel very tired during the day and experience cataplexy. Cataplexy is a sudden loss of muscle strength, which can cause someone to collapse or lose control of their muscles for a short time. This is often triggered by strong emotions, such as laughter or surprise. They may also have trouble sleeping well at night.\n* NT2: People with NT2 feel sleepy during the day, just like NT1, but they do not have cataplexy.\n\nOrexin is a protein in the brain that helps coordinate a system that plays an important role in helping people to stay awake during the daytime. Cleminorexton is designed to mimic the action of orexin. The purpose of this study is to see how safe and tolerable cleminorexton is in NT1 and NT2 and learn about what the drug does to the body. Another goal of the study is to see if cleminorexton can help people with NT1 and NT2 feel less sleepy and make other symptoms better.","The SAPPHIRE Clinical Trial\n\nThe Sponsor may in the future, through a protocol amendment, expand the protocol to include participants with idiopathic hypersomnia (IH) in Cohort C.",[19,20],"Narcolepsy Type 1","Narcolepsy Type 2",[22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,19,20,38,39,40,41,42],"NT1","NT2","Excessive Daytime Sleepiness","Orexin Receptor 2 agonist","Central Disorders of Hypersomnia","Disorders of Excessive Somnolence","Dyssomnias","Nervous System Diseases","Mental Disorders","Hypersomnia","Hypersomnolence","Sleep Wake Disorders","Sleep Disorder","Sleep","Sleepiness","Cataplexy","Orexin","ORX750","Cleminorexton","Narcolepsy","SAPPHIRE","INTERVENTIONAL","TREATMENT",[46,47],"PHASE2","PHASE3",{"count":49,"type":50},222,"ESTIMATED",[52,61],{"type":53,"name":54,"description":55,"armGroupLabels":56},"DRUG","cleminorexton","Oral cleminorexton capsule",[57,58,59,60],"Group A - Narcolepsy Type 1 (Dose 1)","Group A - Narcolepsy Type 1 (Dose 2)","Group B - Narcolepsy Type 2 (Dose 1)","Group B - Narcolepsy Type 2 (Dose 2)",{"type":53,"name":62,"description":63,"armGroupLabels":64},"Placebo","matching placebo capsule",[65,66],"Group A - Narcolepsy Type 1 (placebo)","Group B - Narcolepsy Type 2 (placebo)",[68],{"measure":69,"timeFrame":70},"Change from baseline in mean sleep latency (average of the first 4 trials) on the Maintenance of Wakefulness Test (MWT)","Baseline to week 12",[72,75,79,81,84,86,88,90,92,94,96,98],{"measure":73,"timeFrame":74},"Change from baseline in Epworth Sleepiness Scale (ESS) total score","Baseline to Week 12",{"measure":76,"description":77,"timeFrame":78},"Weekly Cataplexy Rate (WCR)","Measurement specific to Group A","Week 12",{"measure":80,"description":77,"timeFrame":74},"Change from baseline in Narcolepsy Severity Scale for Clinical Trials (NSS-CT)",{"measure":82,"description":83,"timeFrame":74},"Change from baseline in Narcolepsy Severity Scale-2 for Clinical Trials (NSS2-CT) total score","Measurement specific to Group B",{"measure":85,"timeFrame":74},"Incidence, Severity, and casual relationship of participants with Treatment Emergent Adverse Events (TEAEs)",{"measure":87,"timeFrame":74},"Number of participants with abnormal changes from baseline in clinical laboratory tests",{"measure":89,"timeFrame":74},"Number of participants with abnormal changes from baseline in vital signs",{"measure":91,"timeFrame":74},"Number of participants with abnormal changes from baseline in 12-lead electrocardiograms (ECGs)",{"measure":93,"timeFrame":74},"Number of participants with at least 1 endorsement of Item 4 or 5 on Columbia-Suicide Severity Rating Scale (C-SSRS)",{"measure":95,"timeFrame":74},"Cmax: Maximum observed plasma concentration",{"measure":97,"timeFrame":74},"Tmax: Time of Maximum Concentration for cleminorexton",{"measure":99,"timeFrame":74},"AUC: Area under the plasma concentration-time curve","ALL","18 Years","70 Years",{"inclusion":104,"exclusion":110,"raw_text":113},[105,106,107,108,109],"18-70 years of age","Body Mass Index (BMI) within the range ≥ 17.0 and ≤ 45 kg\u002Fm\\^2 (inclusive)","Meets the diagnostic criteria of Narcolepsy Type 1 (NT1) or Type 2 (NT2) according to International Classification of Sleep Disorders, 3rd edition, Text Revision edition (ICSD-3-TR) criteria","Is willing and able to discontinue all medications used for the treatment of narcolepsy","Is willing and able to adhere to additional protocol requirements",[111,112],"Medical disorder other than NT1 or NT2, that is associated with excessive daytime sleepiness (EDS)","Presence of significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, hematological, malignancy, endocrine, neurological or psychiatric disease","Key Inclusion Criteria:\n\n* 18-70 years of age\n* Body Mass Index (BMI) within the range ≥ 17.0 and ≤ 45 kg\u002Fm\\^2 (inclusive)\n* Meets the diagnostic criteria of Narcolepsy Type 1 (NT1) or Type 2 (NT2) according to International Classification of Sleep Disorders, 3rd edition, Text Revision edition (ICSD-3-TR) criteria\n* Is willing and able to discontinue all medications used for the treatment of narcolepsy\n* Is willing and able to adhere to additional protocol requirements\n\nKey Exclusion Criteria:\n\n* Medical disorder other than NT1 or NT2, that is associated with excessive daytime sleepiness (EDS)\n* Presence of significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, hematological, malignancy, endocrine, neurological or psychiatric disease",[115,116],"ADULT","OLDER_ADULT",[118,127,135,138,141,144,151,158,166,174,182,189,197,204,212],{"facility":119,"status":8,"city":120,"state":121,"zip":122,"country":123,"geoPoint":124},"Colorado Springs, Colorado","Colorado Springs","Colorado","80918","United States",{"lat":125,"lon":126},38.83388,-104.82136,{"facility":128,"status":8,"city":129,"state":130,"zip":131,"country":123,"geoPoint":132},"Miami, Florida","Miami","Florida","33155",{"lat":133,"lon":134},25.77427,-80.19366,{"facility":128,"status":8,"city":129,"state":130,"zip":136,"country":123,"geoPoint":137},"33166",{"lat":133,"lon":134},{"facility":128,"status":8,"city":129,"state":130,"zip":139,"country":123,"geoPoint":140},"33176",{"lat":133,"lon":134},{"facility":128,"status":8,"city":129,"state":130,"zip":142,"country":123,"geoPoint":143},"33186",{"lat":133,"lon":134},{"facility":145,"status":8,"city":146,"state":130,"zip":147,"country":123,"geoPoint":148},"Miami Lakes, Florida","Miami Lakes","33014",{"lat":149,"lon":150},25.90871,-80.30866,{"facility":152,"status":8,"city":153,"state":130,"zip":154,"country":123,"geoPoint":155},"Orlando, Florida","Orlando","32807",{"lat":156,"lon":157},28.53834,-81.37924,{"facility":159,"status":8,"city":160,"state":161,"zip":162,"country":123,"geoPoint":163},"Atlanta, Georgia","Atlanta","Georgia","30328",{"lat":164,"lon":165},33.749,-84.38798,{"facility":167,"status":8,"city":168,"state":169,"zip":170,"country":123,"geoPoint":171},"Flowood Mississippi","Flowood","Mississippi","39232",{"lat":172,"lon":173},32.30959,-90.13898,{"facility":175,"status":8,"city":176,"state":177,"zip":178,"country":123,"geoPoint":179},"Denver, North Carolina","Denver","North Carolina","28037",{"lat":180,"lon":181},35.53125,-81.0298,{"facility":183,"status":8,"city":184,"state":177,"zip":185,"country":123,"geoPoint":186},"Huntersville, North Carolina","Huntersville","28078",{"lat":187,"lon":188},35.41069,-80.84285,{"facility":190,"status":8,"city":191,"state":192,"zip":193,"country":123,"geoPoint":194},"Cincinnati, Ohio","Cincinnati","Ohio","45245",{"lat":195,"lon":196},39.12711,-84.51439,{"facility":198,"status":8,"city":199,"state":192,"zip":200,"country":123,"geoPoint":201},"Dublin, Ohio","Dublin","43017",{"lat":202,"lon":203},40.09923,-83.11408,{"facility":205,"status":8,"city":206,"state":207,"zip":208,"country":123,"geoPoint":209},"Columbia, South Carolina","Columbia","South Carolina","29201",{"lat":210,"lon":211},34.00071,-81.03481,{"facility":213,"status":8,"city":214,"state":215,"zip":216,"country":123,"geoPoint":217},"Sugar Land, Texas","Sugar Land","Texas","77478",{"lat":218,"lon":219},29.61968,-95.63495,[221],{"name":222,"role":223,"phone":224,"email":225},"Centessa Pharmaceuticals","CONTACT","617-468-5770","ORX750trials@centessa.com",[],[],[],{"nct_id":4,"conditions":230,"biomarkers":233},[231,232],"Narcolepsy type 1","Narcolepsy without Cataplexy",[234],"Orexin Receptor Type 2",{"nct_id":4,"found":236,"summary":237,"prompt_version":247},true,{"design":238,"status":239,"heading":240,"summary":241,"follow_up":242,"word_count":243,"commitments":244,"compensation":245,"drugs_mentioned":246},"This is an interventional study comparing cleminorexton to a placebo. It plans to enroll 222 participants.","completed","Cleminorexton for Narcolepsy Type 1 and Type 2","This study is looking into how well a medication called cleminorexton works compared to a placebo (an inactive capsule that looks the same) for people with Narcolepsy Type 1 (NT1) or Narcolepsy Type 2 (NT2). These conditions cause extreme daytime sleepiness. The main goal is to see if cleminorexton helps you stay awake longer, measured by a test called the Maintenance of Wakefulness Test (MWT) over 12 weeks. You might be able to join if you are 18 to 70 years old, have been diagnosed with NT1 or NT2, and are able to stop other medications for your condition. The study plans to enroll 222 participants.","The primary endpoint is measured at 12 weeks, which suggests follow-up for at least that duration.",106,"Not specified in the trial record.","Not stated in the trial record.",[54,62],"v2"]