Befejeződött3. fázis
A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy
A legfontosabb adatok
- Ki végzi
- Axsome Therapeutics, Inc.
- Hol
- Alabaster, Atlanta, Austin, Boulder, Brandon, Brooklyn, Charleston, Chevy Chase, Cincinnati, Clearwater, Colorado Springs, Columbia, Denver, Doral, Fort Wayne, Gainesville, Gastonia, Honolulu, Huntersville, Kalamazoo, Kissimmee, Las Vegas, Macon, Miami, Miami Lakes, Neptune City, New Hyde Park, Newton, North Dartmouth, Novi, Peoria, Phoenix, Redwood City, San Antonio, San Diego, Santa Ana, Santa Monica, St Louis, St. Petersburg, Stockbridge, Sugar Land, Tampa, Williamsburg, Winter Park és Wyomissing (Egyesült Államok)Mind a 45 helyszín megnézéseMég 1 másik országban, 2 helyszínen
- Azonosító
- Állapot
- Befejeződött
- Fázis
- 3. fázis
- Résztvevők
- 90 fő vett részt
- Kezdés
- 2021. szept. 15.
- Befejezés
- 2024. márc. 15.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoportAz egyik csoport placebót (hatóanyag nélküli szert) kap, összehasonlításként.
- A vizsgált kezelések
- AXS-12 (reboxetine)
- Placebo
- A regiszteradat frissítve
- 2026. május 28.
Ki vehet részt
- Életkor
- 15 év – 75 év
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 5 feltétel megnézéseKevesebb
Ki vehet részt
- Male or female subjects between 15 and 75 years of age, inclusive
- Primary diagnosis of narcolepsy with cataplexy
- Willing and able to comply with the study requirements
Ki nem vehet részt
- Other clinically significant conditions potentially causing EDS
- Clinically significant psychiatric disorders
Helyszínek itt: Egyesült Államok
Még 1 másik országban, 2 helyszínen
- Alabaster, AlabamaHospital not named in the registry
- Atlanta, GeorgiaHospital not named in the registry
- Austin, TexasHospital not named in the registry
- Boulder, ColoradoHospital not named in the registry
- Brandon, FloridaHospital not named in the registry
- Brooklyn, New YorkHospital not named in the registry
- Charleston, South CarolinaHospital not named in the registry
- Chevy Chase, MarylandHospital not named in the registry
- Cincinnati, OhioHospital not named in the registry
- Clearwater, FloridaHospital not named in the registry
- Colorado Springs, ColoradoHospital not named in the registry
- Columbia, South CarolinaHospital not named in the registry
- Denver, North CarolinaHospital not named in the registry
- Doral, FloridaHospital not named in the registry
- Fort Wayne, IndianaHospital not named in the registry
- Gainesville, GeorgiaHospital not named in the registry
- Gastonia, North CarolinaHospital not named in the registry
- Honolulu, HawaiiHospital not named in the registry
- Huntersville, North CarolinaHospital not named in the registry
- Kalamazoo, MichiganHospital not named in the registry
- Kissimmee, FloridaHospital not named in the registry
- Las Vegas, NevadaHospital not named in the registry
- Macon, GeorgiaHospital not named in the registry
- Miami, FloridaHospital not named in the registry
- Miami Lakes, FloridaHospital not named in the registry
- Neptune City, New JerseyHospital not named in the registry
- New Hyde Park, New YorkHospital not named in the registry
- Newton, MassachusettsHospital not named in the registry
- North Dartmouth, MassachusettsHospital not named in the registry
- Novi, MichiganHospital not named in the registry
- Peoria, ArizonaHospital not named in the registry
- Phoenix, ArizonaHospital not named in the registry
- Redwood City, CaliforniaHospital not named in the registry
- San Antonio, TexasHospital not named in the registry
- San Diego, CaliforniaHospital not named in the registry
- Santa Ana, CaliforniaHospital not named in the registry
- Santa Monica, CaliforniaHospital not named in the registry
- St Louis, MissouriHospital not named in the registry
- St. Petersburg, FloridaHospital not named in the registry
- Stockbridge, GeorgiaHospital not named in the registry
- Sugar Land, TexasHospital not named in the registry
- Tampa, FloridaHospital not named in the registry
- Williamsburg, VirginiaHospital not named in the registry
- Winter Park, FloridaHospital not named in the registry
- Wyomissing, PennsylvaniaHospital not named in the registry
A vizsgálatról
Mit akar kideríteni a vizsgálat
This study is a multi-center, double-blind, placebo-controlled, randomized Phase 3 trial to assess the safety and efficacy of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).
A vizsgálat 2 csoportja
- AXS-12 (reboxetine)A vizsgált kezelés
Up to 5 weeks
- PlaceboPlacebo, összehasonlításként
Up to 5 weeks
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- A Randomized, Double-Blind, Placebo-Controlled, Multi- Center Study to Assess the Efficacy and Safety of AXS-12 in the Treatment of Cataplexy and Excessive Daytime Sleepiness in Subjects With Narcolepsy
- A regiszteradat frissítve
- 2026. május 28.