A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1
Key facts
- Where
- Bruges, Edegem, Ghent, and Namur, BelgiumSee the 4 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07455383, who can take part
Where in Belgium
- BrugesHospital not named in the registryContact: Director, Clinical Trial ManagerTaking people
- EdegemHospital not named in the registryContact: Director, Clinical Trial ManagerTaking people
- GhentHospital not named in the registryContact: Director, Clinical Trial ManagerTaking people
- NamurHospital not named in the registryContact: Director, Clinical Trial ManagerTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Alkermes, Inc.
- Trial code
- NCT07455383
- Record updated
- 7 October 2026
- Original description
The purpose of this study is to measure decreases in daytime sleepiness, cataplexy (sudden loss of muscle tone), and disease symptoms in participants with NT1 when taking ALKS 2680 tablets compared with placebo tablets.Read full original descriptionShow less
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 Study 302)
The purpose of this study is to measure decreases in daytime sleepiness, cataplexy (sudden loss of muscle tone), and disease symptoms in participants with NT1 when taking ALKS 2680 tablets compared with placebo tablets.
Inclusion: Meets the diagnostic criteria of NT1 according to ICSD-3-TR guidelines, confirmed by diagnostic evaluations (either PSG/MSLT* or CSF hypocretin-1 level).
Exclusion: Is currently enrolled in another interventional clinical trial or has received any investigational drug or used any interventional investigational device within 30 days prior to Visit 1. Participants previously enrolled in Study ALKS 2680-201 are not eligible for enrollment; Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle; Has a history or presence at Visit 1 of other clinically significant (treated or untreated) illness, disease, abnormality, or surgical procedure that, in the opinion of the Investigator, might compromise participant safety, interfere with any study assessment, or affect the participant's ability to complete the study; Is currently pregnant, breastfeeding, or is planning to become pregnant during the study.