[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07363720":3,"trial-entities:NCT07363720":297,"trial-summary:NCT07363720":303},{"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":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":42,"secondary_outcomes":47,"sex":74,"minimum_age":75,"maximum_age":76,"healthy_volunteers":15,"eligibility_criteria":77,"std_ages":81,"locations":85,"central_contacts":279,"overall_officials":285,"references":289,"see_also_links":290},"NCT07363720","TAK-861-3003","A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy","A Double-blind, Placebo-Controlled, Randomized Withdrawal Trial to Evaluate the Efficacy and Safety of TAK-861 for the Treatment of Narcolepsy With Cataplexy (Narcolepsy Type 1)","RECRUITING","2026-10-02","2026-07","2026-07-08","2026-01-29","Takeda","INDUSTRY",false,"The main aim of this study is to assess how effective TAK-861 is for treating narcolepsy type 1 and if this effect is maintained over time. Participants will take TAK-861 for a few months and if they meet certain criteria, they will be randomly assigned (by chance, like flipping a coin) to continue taking TAK-861 or take placebo (fake medicine) for up to 4 weeks to see if their narcolepsy symptoms return.","The drug being tested in this study is called TAK-861. This study will look at how effective TAK-861 is for the treatment of narcolepsy type 1 and how well this effect is maintained over time. This study also evaluates how safe TAK-861 is and what adverse events may be associated with taking the drug and stopping the drug in participants with NT1.\n\nThe study will enroll approximately 88 participants. All participants will take TAK-861 during the open-label (OL) treatment period. Participants who meet certain criteria at the end of the OL Treatment Period will be randomized to one of two treatment groups for the up to 4-week double-blind randomized withdrawal (RW) Period. Participants will be randomized to one of the following treatment groups during the Double-blind RW Period:\n\n1. TAK-861 (same dose participant was taking at the end of the OL Treatment Period)\n2. Placebo\n\nThe randomized withdrawal period may last up to 4 weeks. Participants whose NT1 symptoms get worse during the RW period and whose Epworth Sleepiness Scale score rises above a certain score will stop the treatment and be invited to continue in a separate long term extension study. Participants who choose not to take part in the extension study will be followed-up for 4 weeks after their last dose of study drug. This multi-center trial will be conducted globally.",[19,20],"Narcolepsy Type 1 (NT1)","Narcolepsy With Cataplexy",[22],"Drug Therapy","INTERVENTIONAL","TREATMENT",[26],"PHASE3",{"count":28,"type":29},88,"ESTIMATED",[31,37],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DRUG","TAK-861","TAK-861 tablets",[36],"Double-blind RW Period: TAK-861",{"type":32,"name":38,"description":39,"armGroupLabels":40},"Placebo","TAK-861-matching placebo tablets",[41],"Double-blind RW Period: Placebo",[43],{"measure":44,"description":45,"timeFrame":46},"Time to Loss of Response in the Epworth Sleepiness Scale (ESS) Score During the Up to 4-Week RW Period","The ESS provides individuals with 8 different situations of daily life and asks them how likely they are to fall asleep in those situations (scored 0 to 3) and to try to imagine their likelihood of dozing even if they have not actually been in the identical situation; the scores are summed to give an overall score of 0 to 24. Higher scores indicate stronger subjective daytime sleepiness, and scores below 10 are considered to be within normal range.","Up to 4-week RW period",[48,52,55,58,61,64,67,70],{"measure":49,"description":50,"timeFrame":51},"Change From the End of the OL Treatment Period to Week 2 of the RW Period on the Maintenance of Wakefulness Test (MWT)","The MWT evaluates a person's ability to remain awake under soporific conditions for a defined period of time. Because there is no biological measure of wakefulness, wakefulness is measured indirectly by the inability or delayed tendency to fall asleep. This tendency to fall asleep is measured via electroencephalography (EEG)-derived sleep latency in the MWT. The MWT consists of four 40-minute sessions. Sleep latency in each wake trial will be recorded. Participants will be required to stay awake in between the 4 sessions.","From the end of the OL treatment period (Week 16) to Week 2 of the RW period (Week 18)",{"measure":53,"timeFrame":54},"Weekly Cataplexy Rate (WCR) at Week 2 of the RW Period","Week 2 of the RW period",{"measure":56,"description":57,"timeFrame":51},"Change from the End of the OL Treatment Period to Week 2 of the RW Period in Mean Number of Lapses on the Psychomotor Vigilance Test (PVT)","The PVT is a simple reaction performance task with a duration of 10 minutes that aims to measure sustained attention.",{"measure":59,"description":60,"timeFrame":54},"Number of Participants Reporting Much or Very Much Worse in Patient Global Impression of Change (PGI-C) Score at Week 2 of the RW Period","The PGI-C is a participant self-rated scale to assess improvement in daytime sleepiness and overall narcolepsy symptoms. It measures change due to treatment relative to baseline on a 7-point scale ranging from a score of 1 (\"very much improved\") to score of 7 (\"very much worse\").",{"measure":62,"description":63,"timeFrame":51},"Change from the End of the OL Treatment Period to Week 2 of the RW Period in Narcolepsy Severity Scale for Clinical Trials (NSS-CT) Total Score","The NSS-CT is a 15-item self-administered questionnaire assesses the severity and consequences of the 5 major narcolepsy symptoms such as daytime sleepiness, cataplexy, hallucinations, sleep paralysis, and disturbed night-time sleep (DNS) with a total score range of 0 to 57 (sum of 6 items that assess symptoms severity are rated using a six-point Likert scale \\[0-5\\] and 9 items that describe the symptom effect on daily life are rated using a four-point Likert scale \\[0-3\\]. Higher total scores mean a worse outcome.",{"measure":65,"description":66,"timeFrame":51},"Change from the End of the OL Treatment Period to Week 2 of the RW Period in Functional Impacts of Narcolepsy Instrument (FINI) Domain Scores","The FINI measures the functional impacts of narcolepsy across 6 domains. Each domain is scored from 0 to 4, where 0 indicates the best health and 4 the worst.",{"measure":68,"description":69,"timeFrame":51},"Change from the End of the OL Treatment Period to Week 2 of the RW Period in Number of Correct Responses on the International Digit Symbol Substitution Test-symbols (iDSST-s)","The iDSST-s is a processing speed test that is based on the pre-existing pencil and paper version of the Digit Symbol Substitution Test. The participants are presented with a legend that defines 9 symbols, with each symbol corresponding to a digit from 1 to 9. The participant is then presented with a conveyer belt in the middle of the screen that displays a series of empty boxes labelled with a number. The participant must select the symbol that corresponds to the number of a given highlighted box from symbol options presented at the bottom of the screen. The participant must try to place as many correct symbols in the boxes as possible over the duration of the test.",{"measure":71,"description":72,"timeFrame":73},"Number of Participants With At Least One Treatment-Emergent Adverse Event (TEAE)","An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product. A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product.","From Screening to End of study (approximately 31 weeks)","ALL","16 Years","70 Years",{"inclusion":78,"exclusion":79,"raw_text":80},[],[],"Inclusion Criteria:\n\n1. The participant has a body mass index (BMI) within the range 18 to 40 kilograms per square meter (kg\u002Fm\\^2).\n2. The participant has an International Classification of Sleep Disorders, Third Edition (ICSD-3) or International Classification of Sleep Disorders, Third Edition, Text Revision (ICSD-3-TR) diagnosis of NT1.\n3. The participant is positive for the human leukocyte antigen (HLA) genotype Major Histocompatibility Complex, Class II, DQ Beta 1 (HLA-DQB1\\*06:02) or results from radioimmunoassay indicate the participant's CSF OX\u002Fhypocretin-1 concentration is ≤110 pg\u002FmL (or less than one-third of the mean values obtained in normal participants within the same standardized assay).\n\nExclusion Criteria:\n\n1. The participant has a current medical disorder, other than narcolepsy with cataplexy, associated with EDS.\n2. The participant a) has a history of myocardial infarction, b) has a history of clinically significant hepatic disease, thyroid disease, coronary artery disease, cardiac rhythm abnormality or heart failure, or c) has any medical condition (such as unstable cardiovascular, pulmonary, renal or gastrointestinal disease.\n3. The participant has current or recent (within 6 months) gastrointestinal disease that is expected to influence the absorption of drugs.\n4. The participant has a history of cancer in the past 5 years.\n5. The participant has a clinically significant history of head injury or head trauma.\n6. The participant has a history of epilepsy, seizure, or convulsion (except for a single febrile seizure in childhood).\n7. The participant has a history of cerebral ischemia, transient ischemic attack (less than 5 years from screening), intracranial aneurysm, or arteriovenous malformation.",[82,83,84],"CHILD","ADULT","OLDER_ADULT",[86,95,103,110,118,126,134,141,149,156,164,172,180,187,194,203,210,219,227,235,244,252,259,266,272],{"facility":87,"status":8,"city":88,"state":89,"zip":90,"country":91,"geoPoint":92},"Takeda Site 15","Redwood City","California","94063","United States",{"lat":93,"lon":94},37.48522,-122.23635,{"facility":96,"status":8,"city":97,"state":98,"zip":99,"country":91,"geoPoint":100},"Takeda Site 19","Brandon","Florida","33511",{"lat":101,"lon":102},27.9378,-82.28592,{"facility":104,"status":8,"city":105,"state":98,"zip":106,"country":91,"geoPoint":107},"Takeda Site 22","Miami","33155",{"lat":108,"lon":109},25.77427,-80.19366,{"facility":111,"status":8,"city":112,"state":113,"zip":114,"country":91,"geoPoint":115},"Takeda Site 23","Southfield","Michigan","48075",{"lat":116,"lon":117},42.47337,-83.22187,{"facility":119,"status":8,"city":120,"state":121,"zip":122,"country":91,"geoPoint":123},"Takeda Site 20","Middletown","New Jersey","07748",{"lat":124,"lon":125},40.39428,-74.11709,{"facility":127,"status":8,"city":128,"state":129,"zip":130,"country":91,"geoPoint":131},"Takeda Site 24","Durham","North Carolina","27710-4000",{"lat":132,"lon":133},35.99403,-78.89862,{"facility":135,"status":8,"city":136,"state":129,"zip":137,"country":91,"geoPoint":138},"Takeda Site 25","Winston-Salem","27103",{"lat":139,"lon":140},36.09986,-80.24422,{"facility":142,"status":8,"city":143,"state":144,"zip":145,"country":91,"geoPoint":146},"Takeda Site 16","Cincinnati","Ohio","45245",{"lat":147,"lon":148},39.12711,-84.51439,{"facility":150,"status":8,"city":151,"state":144,"zip":152,"country":91,"geoPoint":153},"Takeda Site 18","Cleveland","44195",{"lat":154,"lon":155},41.4995,-81.69541,{"facility":157,"status":8,"city":158,"state":159,"zip":160,"country":91,"geoPoint":161},"Takeda Site 17","Columbia","South Carolina","29201",{"lat":162,"lon":163},34.00071,-81.03481,{"facility":165,"status":8,"city":166,"state":167,"zip":168,"country":91,"geoPoint":169},"Takeda Site 21","Austin","Texas","78731",{"lat":170,"lon":171},30.26715,-97.74306,{"facility":173,"status":8,"city":174,"zip":175,"country":176,"geoPoint":177},"Takeda Site 1","Montpellier","34295","France",{"lat":178,"lon":179},43.61093,3.87635,{"facility":181,"status":8,"city":182,"zip":183,"country":176,"geoPoint":184},"Takeda Site 2","Paris","75013",{"lat":185,"lon":186},48.85341,2.3488,{"facility":188,"status":8,"city":189,"zip":190,"country":176,"geoPoint":191},"Takeda Site 3","Toulouse","31059",{"lat":192,"lon":193},43.60426,1.44367,{"facility":195,"status":8,"city":196,"state":197,"zip":198,"country":199,"geoPoint":200},"Takeda Site 4","Schwerin","Mecklenburg-Vorpommern","19053","Germany",{"lat":201,"lon":202},53.62937,11.41316,{"facility":204,"status":8,"city":205,"zip":206,"country":199,"geoPoint":207},"Takeda Site 5","Berlin","10117",{"lat":208,"lon":209},52.52437,13.41053,{"facility":211,"status":8,"city":212,"state":213,"zip":214,"country":215,"geoPoint":216},"Takeda Site 6","Bologna","Emilia-Romagna","40139","Italy",{"lat":217,"lon":218},44.49381,11.33875,{"facility":220,"status":8,"city":221,"state":222,"zip":223,"country":215,"geoPoint":224},"Takeda Site 7","Rome","Lazio","00133",{"lat":225,"lon":226},41.89193,12.51133,{"facility":228,"status":8,"city":229,"zip":230,"country":231,"geoPoint":232},"Takeda Site 8","Heemstede","2103 SW","Netherlands",{"lat":233,"lon":234},52.34992,4.62301,{"facility":236,"status":8,"city":237,"state":238,"zip":239,"country":240,"geoPoint":241},"Takeda Site 12","Vitoria-Gasteiz","Alava","01004","Spain",{"lat":242,"lon":243},42.84998,-2.67268,{"facility":245,"status":8,"city":246,"state":247,"zip":248,"country":240,"geoPoint":249},"Takeda Site 11","Alzira","Valencia","46600",{"lat":250,"lon":251},39.15,-0.43333,{"facility":253,"status":8,"city":254,"zip":255,"country":240,"geoPoint":256},"Takeda Site 10","Barcelona","08036",{"lat":257,"lon":258},41.38879,2.15899,{"facility":260,"status":8,"city":261,"zip":262,"country":240,"geoPoint":263},"Takeda Site 9","Madrid","28043",{"lat":264,"lon":265},40.4165,-3.70256,{"facility":267,"status":8,"city":268,"state":269,"zip":270,"country":271},"Takeda Site 13","Barmelweid","Canton of Aargau","5017","Switzerland",{"facility":273,"status":8,"city":274,"zip":275,"country":271,"geoPoint":276},"Takeda Site 14","Bern","3010",{"lat":277,"lon":278},46.94809,7.44744,[280],{"name":281,"role":282,"phone":283,"email":284},"Takeda Contact","CONTACT","+1-877-825-3327","medinfoUS@takeda.com",[286],{"name":287,"affiliation":13,"role":288},"Study Director","STUDY_DIRECTOR",[],[291,294],{"label":292,"url":293},"To obtain more information on the study, click here\u002Fon this link.","https:\u002F\u002Fclinicaltrials.takeda.com\u002Fstudy-detail\u002F84f5e1991d9d4f5f??page=1&idFilter=TAK-861-3003",{"label":295,"url":296},"Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.","https:\u002F\u002Fclinicaltrials.takeda.com\u002F?chat=true",{"nct_id":4,"conditions":298,"biomarkers":300},[299],"Narcolepsy type 1",[301,302],"HLA-DQB1*06:02 antigen","Orexin A",{"nct_id":4,"found":304,"summary":305,"prompt_version":315},true,{"design":306,"status":307,"heading":308,"summary":309,"follow_up":310,"word_count":311,"commitments":312,"compensation":313,"drugs_mentioned":314},"This is an interventional study where all participants first take TAK-861. Then, some participants will be randomly assigned to either continue TAK-861 or take a placebo for up to 4 weeks.","completed","A Study of TAK-861 for Narcolepsy with Cataplexy","This study is testing a drug called TAK-861 to see how well it treats narcolepsy type 1 (NT1), a sleep disorder that causes extreme daytime sleepiness and sudden muscle weakness (cataplexy). The main goal is to find out if TAK-861 is effective and if its effects last over time. You might be able to join if you are 16 to 70 years old, have NT1, and your body mass index (BMI) is between 18 and 40. All participants will first take TAK-861 for several months. If you meet certain conditions, you will then be randomly assigned to continue taking TAK-861 or switch to a placebo (an inactive pill) for up to 4 weeks. The study will measure how long it takes for your sleepiness to return during this period. About 88 people will participate in this study, which is currently recruiting.","If your symptoms worsen during the randomized withdrawal period, you will stop treatment and may be invited to a separate long-term study. If you don't join the extension study, you will be followed for 4 weeks after your last dose.",141,"You will take TAK-861 tablets for several months, followed by up to 4 weeks of either TAK-861 or placebo tablets.","Not stated in the trial record.",[33,38],null]