Befejeződött3. fázis
A Study to Assess the Efficacy and Safety of Solriamfetol in Subjects With ADHD (FOCUS)
A legfontosabb adatok
- Ki végzi
- Axsome Therapeutics, Inc.
- Hol
- Austin, Bellaire, Berlin, Boston, Cherry Hill, Cincinnati, Clermont, Colorado Springs, Dallas, Doral, Draper, Encino, Everett, Gainesville, Garden Grove, Jacksonville, Kettering, Las Vegas, Lauderhill, Lincoln, Marietta, Media, Memphis, Miami Lakes, Mount Kisco, New York, Newport Beach, North Charleston, Oklahoma City, Orlando, Overland Park, Princeton, Raleigh, Riverside, Saint Charles, San Antonio, Santa Ana, Sherman Oaks, Torrance és Walnut Creek (Egyesült Államok)Mind a 40 helyszín megnézése
- Azonosító
- Állapot
- Befejeződött
- Fázis
- 3. fázis
- Résztvevők
- 516 fő vett részt
- Kezdés
- 2023. júl. 6.
- Befejezés
- 2025. márc. 14.
- A vizsgálat típusa
- Beavatkozással járó, 3 csoportAz egyik csoport placebót (hatóanyag nélküli szert) kap, összehasonlításként.
- A vizsgált kezelések
- Solriamfetol 150 mg
- Solriamfetol 300 mg
- Placebo
- A regiszteradat frissítve
- 2026. február 10.
Ki vehet részt
- Életkor
- 18 év – 55 év
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 6 feltétel megnézéseKevesebb
Ki vehet részt
- Primary diagnosis of ADHD according to DSM-5 criteria
- Provides written informed consent to participate in the study before the conduct of any study procedures
- Male or female, aged 18 to 55 inclusive
Ki nem vehet részt
- Prior exposure to solriamfetol/Sunosi, through either a clinical study or prescription
- Unable to comply with study procedures
- Medically inappropriate for study participation in the opinion of the investigator
Helyszínek itt: Egyesült Államok
- Austin, TexasHospital not named in the registry
- Bellaire, TexasHospital not named in the registry
- Berlin, New JerseyHospital not named in the registry
- Boston, MassachusettsHospital not named in the registry
- Cherry Hill, New JerseyHospital not named in the registry
- Cincinnati, OhioHospital not named in the registry
- Clermont, FloridaHospital not named in the registry
- Colorado Springs, ColoradoHospital not named in the registry
- Dallas, TexasHospital not named in the registry
- Doral, FloridaHospital not named in the registry
- Draper, UtahHospital not named in the registry
- Encino, CaliforniaHospital not named in the registry
- Everett, WashingtonHospital not named in the registry
- Gainesville, GeorgiaHospital not named in the registry
- Garden Grove, CaliforniaHospital not named in the registry
- Jacksonville, FloridaHospital not named in the registry
- Kettering, OhioHospital not named in the registry
- Las Vegas, NevadaHospital not named in the registry
- Lauderhill, FloridaHospital not named in the registry
- Lincoln, NebraskaHospital not named in the registry
- Marietta, GeorgiaHospital not named in the registry
- Media, PennsylvaniaHospital not named in the registry
- Memphis, TennesseeHospital not named in the registry
- Miami Lakes, FloridaHospital not named in the registry
- Mount Kisco, New YorkHospital not named in the registry
- New YorkHospital not named in the registry
- Newport Beach, CaliforniaHospital not named in the registry
- North Charleston, South CarolinaHospital not named in the registry
- Oklahoma City, OklahomaHospital not named in the registry
- Orlando, FloridaHospital not named in the registry
- Overland Park, KansasHospital not named in the registry
- Princeton, New JerseyHospital not named in the registry
- Raleigh, North CarolinaHospital not named in the registry
- Riverside, CaliforniaHospital not named in the registry
- Saint Charles, MissouriHospital not named in the registry
- San Antonio, TexasHospital not named in the registry
- Santa Ana, CaliforniaHospital not named in the registry
- Sherman Oaks, CaliforniaHospital not named in the registry
- Torrance, CaliforniaHospital not named in the registry
- Walnut Creek, CaliforniaHospital not named in the registry
A vizsgálatról
Mit akar kideríteni a vizsgálat
FOCUS (Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol) is a Phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel- group trial to assess the efficacy and safety of solriamfetol in adults with ADHD.
A vizsgálat 3 csoportja
- Solriamfetol 150 mgA vizsgált kezelés
Up to 6 weeks
- Solriamfetol 300 mgA vizsgált kezelés
Up to 6 weeks
- PlaceboPlacebo, összehasonlításként
Up to 6 weeks
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- A Phase 3, Randomized, Double-blind, Placebo-controlled Trial of Solriamfetol in Adults With ADHD.
- A regiszteradat frissítve
- 2026. február 10.