A Study of TAK-861 for the Treatment of Narcolepsy Type 1
A legfontosabb adatok
- Ki végzi
- Takeda
- Hol
- Atlanta, Boston, Cincinnati, Cleveland, Columbia, Dallas, Danville, Denver, Norfolk, Orlando, Phoenix, Redwood City, Santa Ana, St Louis és Upland (Egyesült Államok)Mind a 15 helyszín megnézéseMég 10 másik országban, 38 helyszínen
- Azonosító
- NCT06470828
- EU 2023-508465-32-00
- JRCT2051240083
- Állapot
- Befejeződött
- Fázis
- 3. fázis
- Résztvevők
- 168 fő vett részt
- Kezdés
- 2024. júl. 2.
- Befejezés
- 2025. jún. 3.
- A vizsgálat típusa
- Beavatkozással járó, 3 csoportAz egyik csoport placebót (hatóanyag nélküli szert) kap, összehasonlításként.
- A vizsgált kezelések
- Oveporexton
- Placebo
- A regiszteradat frissítve
- 2026. augusztus 31.
Ki vehet részt
- Életkor
- 16 év – 70 év
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 11 feltétel megnézéseKevesebb
Ki vehet részt
- The participant has a body mass index (BMI) within the range 18 to 40 kilograms per meter square (kg/m\^2)
- 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
- The participant has greater than or equal to (≥)4 partial or complete episodes of cataplexy/week (WCR)
- The participant is positive for the human leukocyte antigen (HLA) genotype HLA-DQB1*06:02 or results from radioimmunoassay indicate the participant's cerebrospinal fluid (CSF) orexin (OX)/hypocretin-1 concentration is less than or equal to (≤)110 picograms per milliliter (pg/mL) [or less than one-third of the mean values obtained in normal participants within the same standardized assay]
Ki nem vehet részt
- The participant has a current medical disorder, other than narcolepsy with cataplexy, associated with EDS
- 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)
- The participant has current or recent (within 6 months) gastrointestinal disease that is expected to influence the absorption of drugs
- The participant has a history of cancer in the past 5 years
- The participant has a clinically significant history of head injury or head trauma
- The participant has a history of epilepsy, seizure, or convulsion
- The participant has a history of cerebral ischemia, transient ischemic attack (<5 years from screening), intracranial aneurysm, or arteriovenous malformation
Helyszínek itt: Egyesült Államok
Még 10 másik országban, 38 helyszínen
- Atlanta, GeorgiaHospital not named in the registryNo longer taking part
- Boston, MassachusettsHospital not named in the registryNo longer taking part
- Cincinnati, OhioHospital not named in the registryNo longer taking part
- Cleveland, OhioHospital not named in the registryNo longer taking part
- Columbia, South CarolinaHospital not named in the registryNo longer taking part
- Dallas, TexasHospital not named in the registryNo longer taking part
- Danville, PennsylvaniaHospital not named in the registryNo longer taking part
- Denver, North CarolinaHospital not named in the registryNo longer taking part
- Norfolk, VirginiaHospital not named in the registryNo longer taking part
- Orlando, FloridaHospital not named in the registryNo longer taking part
- Phoenix, ArizonaHospital not named in the registryNo longer taking part
- Redwood City, CaliforniaHospital not named in the registryNo longer taking part
- Santa Ana, CaliforniaHospital not named in the registryNo longer taking part
- St Louis, MissouriHospital not named in the registryNo longer taking part
- Upland, CaliforniaHospital not named in the registryNo longer taking part
A vizsgálatról
Mit akar kideríteni a vizsgálat
The main aim of this study is to learn how effective TAK-861 (oveporexton) is in improving excessive sleepiness during the day (called excessive daytime sleepiness or EDS) after 3 months of treatment. Other aims are to learn how effective TAK-861 (oveporexton) is in lowering the number of sudden, unexpected attacks of muscle weakness while staying conscious (cataplexy) in a week; to learn the effect TAK-861 (oveporexton) has on participants' ability to maintain attention, participant's overall quality of life, the spectrum of narcolepsy symptoms, and daily life functions; and to learn about the safety of TAK-861 (oveporexton).
A vizsgálat 3 csoportja
- PlaceboPlacebo, összehasonlításként
Participants received oveporexton (OVE)-matching placebo tablets, orally, for 12 weeks.
- OVE 1 mg BIDA vizsgált kezelés
Participants received OVE tablets, 1 milligram (mg), orally, for 12 weeks.
Kezelés: Oveporexton
- OVE 2 mg BIDA vizsgált kezelés
Participants received OVE tablets, 2 mg, orally, for 12 weeks.
Kezelés: Oveporexton
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on és az EU hivatalos vizsgálati nyilvántartásában (CTIS).
- Hivatalos cím
- A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-861 for the Treatment of Narcolepsy With Cataplexy (Narcolepsy Type 1)
- Publikációk
- Psychometric properties of the novel patient-reported Functional Impacts of Narcolepsy Instrument (FINI) using data from phase 3 clinical trials in narcolepsy type 1.Frontiers in neurology, 2026
- Oveporexton for Narcolepsy Type 1 - Results from Two Phase 3 Trials.The New England journal of medicine, 2026
- A regiszteradat frissítve
- 2026. augusztus 31.