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Befejeződött3. fázis

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
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
A regiszteradat frissítve
2026. augusztus 31.