Under construction – not a live service
Sign in
Taking people in United StatesPhase 3

ALKS 2680 for daytime sleepiness and cataplexy in adults with narcolepsy type 1

Tests ALKS 2680 tablets against placebo in adults with narcolepsy type 1.

Key facts

Who runs it
Alkermes, Inc.
Where
Atlanta, Brandon, Charlotte, Cincinnati, Colombia, Dallas, Frisco, Lansing, Macon, Miami, San Antonio, Spokane, St Louis, Sugar Land, and Winter Park, United StatesSee the 15 sitesAlso in 4 other countries, 5 sites
Trial code
Registry title
A Study to Evaluate the Efficacy, Safety and Tolerability of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 304)
Status
Recruiting
Phase
Phase 3
People taking part
150 people, planned
Started
13 Aug 2026
Expected to end
Jul 2027
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • ALKS 2680 Dose 1
  • ALKS 2680 Dose 2
  • Placebo
Record updated
7 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with narcolepsy type 1 (NT1). It tests whether ALKS 2680 tablets reduce daytime sleepiness and cataplexy (sudden loss of muscle tone) compared with placebo.

Age
18 Years to 70 Years
Sex
All sexes can join.
Disease stage
Narcolepsy type 1 diagnosed by ICSD-3-TR guidelines and confirmed by sleep tests (PSG/MSLT) or a CSF hypocretin-1 level.
Earlier treatment
No investigational drug or investigational device in the 30 days before Visit 1. People who were in Study ALKS 2680-201 cannot join.
Biomarker or test result
Diagnosis confirmed by sleep tests (PSG/MSLT) or by the hypocretin-1 level in the spinal fluid (CSF).

Main reasons for not taking part

  • Another sleep disorder or condition that affects the sleep-wake cycle
  • Other serious illness or surgery that could affect safety or the study, in the doctor's view
  • Currently in another interventional clinical trial
  • Earlier participation in Study ALKS 2680-201
  • Pregnant, breastfeeding, or planning a pregnancy during the study

The registry criteria, word for word

Show all 5 criteriaShow less

Who can take part

  • Meets the diagnostic criteria of NT1 according to ICSD-3-TR guidelines, confirmed by diagnostic evaluations (either PSG/MSLT* or CSF hypocretin-1 level)

Who cannot take part

  • 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

Check if you might fit

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?

Where in United States

Also in 4 other countries, 5 sites

  • Atlanta, GeorgiaHospital not named in the registryContact: Director, Clinical Trial ManagerTaking people
  • Brandon, FloridaHospital not named in the registryContact: Director, Clinical Trial ManagerTaking people
  • Charlotte, North CarolinaHospital not named in the registryContact: Director, Clinical Trial ManagerTaking people
  • Cincinnati, OhioHospital not named in the registryContact: Director, Clinical Trial ManagerTaking people
  • Colombia, South CarolinaHospital not named in the registryContact: Director, Clinical Trial ManagerTaking people
  • Dallas, TexasHospital not named in the registryContact: Director, Clinical Trial ManagerTaking people
  • Frisco, TexasHospital not named in the registryContact: Director, Clinical Trial ManagerTaking people
  • Lansing, MichiganHospital not named in the registryContact: Director, Clinical Trial ManagerTaking people
  • Macon, GeorgiaHospital not named in the registryContact: Director, Clinical Trial ManagerTaking people
  • Miami, FloridaHospital not named in the registryContact: Director, Clinical Trial ManagerTaking people
  • San Antonio, TexasHospital not named in the registryContact: Director, Clinical Trial ManagerTaking people
  • Spokane, WashingtonHospital not named in the registryContact: Director, Clinical Trial ManagerTaking people
  • St Louis, MissouriHospital not named in the registryContact: Director, Clinical Trial ManagerTaking people
  • Sugar Land, TexasHospital not named in the registryContact: Director, Clinical Trial ManagerTaking people
  • Winter Park, FloridaHospital not named in the registryContact: Director, Clinical Trial ManagerTaking people

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • ALKS 2680 Dose 1Treatment being tested
  • ALKS 2680 Dose 2Treatment being tested
  • PlaceboPlacebo, for comparison

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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 304)
Plain-language title
ALKS 2680 for daytime sleepiness and cataplexy in adults with narcolepsy type 1Generated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT07540897, who can take part
Record updated
7 October 2026