A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2
A legfontosabb adatok
- Hol
- Abington, Atlanta, Aurora, Austin, Brandon, Canton, Cincinnati, Cleveland, Colorado Springs, Columbia, Cordova, Denver, Huntersville, Lansing, Lincoln, Little Rock, Los Angeles, Macon, Madison, Miami, Middletown, Peoria, Philadelphia, Redwood City, San Antonio, San Francisco, Santa Ana, Sterling Heights, Stockbridge, Sugar Land, Winter Park és Wyomissing (Egyesült Államok)Mind a 32 helyszín megnézése
- Fázis
- 2. fázis
Helyszínek itt: Egyesült Államok
- Abington, PennsylvaniaHospital not named in the registryNo longer taking part
- Atlanta, GeorgiaHospital not named in the registryNo longer taking part
- Aurora, ColoradoHospital not named in the registryNo longer taking part
- Austin, TexasHospital not named in the registryNo longer taking part
- Brandon, FloridaHospital not named in the registryNo longer taking part
- Canton, OhioHospital 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
- Colorado Springs, ColoradoHospital not named in the registryNo longer taking part
- Columbia, South CarolinaHospital not named in the registryNo longer taking part
- Cordova, TennesseeHospital not named in the registryNo longer taking part
- Denver, ColoradoHospital not named in the registryNo longer taking part
- Huntersville, North CarolinaHospital not named in the registryNo longer taking part
- Lansing, MichiganHospital not named in the registryNo longer taking part
- Lincoln, NebraskaHospital not named in the registryNo longer taking part
- Little Rock, ArkansasHospital not named in the registryNo longer taking part
- Los Angeles, CaliforniaHospital not named in the registryNo longer taking part
- Macon, GeorgiaHospital not named in the registryNo longer taking part
- Madison, WisconsinHospital not named in the registryNo longer taking part
- Miami, FloridaHospital not named in the registryNo longer taking part
- Middletown, New JerseyHospital not named in the registryNo longer taking part
- Peoria, IllinoisHospital not named in the registryNo longer taking part
- Philadelphia, PennsylvaniaHospital not named in the registryNo longer taking part
- Redwood City, CaliforniaHospital not named in the registryNo longer taking part
- San Antonio, TexasHospital not named in the registryNo longer taking part
- San Francisco, CaliforniaHospital not named in the registryNo longer taking part
- Santa Ana, CaliforniaHospital not named in the registryNo longer taking part
- Sterling Heights, MichiganHospital not named in the registryNo longer taking part
- Stockbridge, GeorgiaHospital not named in the registryNo longer taking part
- Sugar Land, TexasHospital not named in the registryNo longer taking part
- Winter Park, FloridaHospital not named in the registryNo longer taking part
- Wyomissing, PennsylvaniaHospital not named in the registryNo longer taking part
A vizsgálat adatai
- Ki végzi
- Alkermes, Inc.
- Azonosító
- NCT06555783EU 2024-515452-20-00
- A regiszteradat frissítve
- 2026. február 27.
- Eredeti leírás
The purpose of this study is to measure the safety and decrease in sleepiness in subjects with narcolepsy type 2 (NT2) when taking ALKS 2680 tablets compared to placebo tablets.A teljes eredeti leírásKevesebb
A Phase 2, Parallel-Group, Dose-Range-Finding Study With Randomized Double-Blind Treatment and Open-Label Periods to Evaluate the Safety and Efficacy of ALKS 2680 in Subjects With Narcolepsy Type 2
The purpose of this study is to measure the safety and decrease in sleepiness in subjects with narcolepsy type 2 (NT2) when taking ALKS 2680 tablets compared to placebo tablets.
Bevonási feltételek: 18-70 years of age; Has a BMI ≥18 and ≤40 kg/m2; Meets the diagnostic criteria of Narcolepsy type 2 according to ICSD-3-TR guidelines; Additionally, meets the following criteria:; Has residual excessive daytime sleepiness; Is willing and able to discontinue any medications prescribed for the management of narcolepsy symptoms for at least 14 days and for the duration of study; Is willing to adhere to additional protocol requirements.
Kizáró feltételek: Is currently enrolled in another clinical study (other than the parent study) or used any investigational drug or device within 30 days prior to Screening; Significant comorbid medical conditions, including other sleep, cardiovascular, psychiatric, hepatic or other disorders may be exclusionary; eligibility will be determined on an individual basis by the study investigator; Is currently pregnant, breastfeeding, or planning to become pregnant during the study.