Narcolepsy Type 1Phase 3Brilliance NT1NCT07455383
A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1
A Phase 3 study testing ALKS 2680 Dose 1 and ALKS 2680 Dose 2 in people with Narcolepsy Type 1, run by Alkermes, Inc. at 44 sites in 10 countries.
Trial summary
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 more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Narcolepsy Type 1
- What is being tested?
- ALKS 2680 Dose 1 and ALKS 2680 Dose 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 44 sitesin 10 countries
- Study dates
- 6 Apr 2026to Jun 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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 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.
- Is currently pregnant, breastfeeding, or is planning to become pregnant during the study
Trial locations and contacts
44 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
44 sites in 10 countries
United States22 sites, 22 recruiting
- Recruiting
Alkermes Investigational Site
Austin, Texas, 78731
- Recruiting
Alkermes Investigational Site
Boulder, Colorado, 80301
- Recruiting
Alkermes Investigational Site
Brandon, Florida, 33511
- Recruiting
Alkermes Investigational Site
Charlotte, North Carolina, 28210
- Recruiting
Alkermes Investigational Site
Cincinnati, Ohio, 45245
- Recruiting
Alkermes Investigational Site
Columbia, South Carolina, 29201
- Recruiting
Alkermes Investigational Site
Cullman, Alabama, 35055
- Recruiting
Alkermes Investigational Site
Kansas City, Kansas, 66160
- Recruiting
Alkermes Investigational Site
Lansing, Michigan, 48911
- Recruiting
Alkermes Investigational Site
Los Angeles, California, 90025
- Recruiting
Alkermes Investigational Site
Macon, Georgia, 31210
- Recruiting
Alkermes Investigational Site
Madison, Wisconsin, 53792
- Recruiting
Alkermes Investigational Site
Miami, Florida, 33176
- Recruiting
Alkermes Investigational Site
Middletown, New Jersey, 07748
- Recruiting
Alkermes Investigational Site
Newton, Massachusetts, 02459
- Recruiting
Alkermes Investigational Site
Novi, Michigan, 48377
- Recruiting
Alkermes Investigational Site
Phoenix, Arizona, 85054
- Recruiting
Alkermes Investigational Site
San Antonio, Texas, 78229
- Recruiting
Alkermes Investigational Site
St Louis, Missouri, 63123
- Recruiting
Alkermes Investigational Site
Sugar Land, Texas, 77478
- Recruiting
Alkermes Investigational Site
Winter Park, Florida, 32789
- Recruiting
Alkermes Investigational Site
Wyomissing, Pennsylvania, 19610
Japan5 sites, 5 recruiting
- Recruiting
Alkermes Investigational Site
Kitakyushu-shi, Fukuoka, 802-0084
- Recruiting
Alkermes Investigational Site
Kumamoto, 862-0954
- Recruiting
Alkermes Investigational Site
Osaka, Osaka, 532-0003
- Recruiting
Alkermes Investigational Site
Shibuya-ku, Tokyo-To, 151-0053
- Recruiting
Alkermes Investigational Site
Shinjuku-Ku, Tokyo-To, 162-0851
Belgium4 sites, 4 recruiting
- Recruiting
Alkermes Investigational Site
Bruges, 8000
- Recruiting
Alkermes Investigational Site
Edegem, 2650
- Recruiting
Alkermes Investigational Site
Ghent, 9000
- Recruiting
Alkermes Investigational Site
Namur
France3 sites, 3 recruiting
- Recruiting
Alkermes Investigational Site
Bordeaux
- Recruiting
Alkermes Investigational Site
Lyon
- Recruiting
Alkermes Investigational Site
Montpellier
Spain3 sites, 3 recruiting
- Recruiting
Alkermes Investigational Site
Barcelona, Barcelona, 08036
- Recruiting
Alkermes Investigational Site
Madrid, 28043
- Recruiting
Alkermes Investigational Site
Vitoria-Gasteiz, Alava, 01004
Canada2 sites, 2 recruiting
- Recruiting
Alkermes Investigational Site
Markham, Ontario, L3R 1A3
- Recruiting
Alkermes Investigational Site
Toronto, Ontario, M5S 3A3
Netherlands2 sites, 2 recruiting
- Recruiting
Alkermes Investigational Site
Heeze, 5591 VE
- Recruiting
Alkermes Investigational Site
Zwolle, Overijssel, 8011
Australia1 site, 1 recruiting
- Recruiting
Alkermes Investigational Site
Macquarie Park, New South Wales, 2113
Taiwan1 site, 1 recruiting
- Recruiting
Alkermes Investigational Site
Kaohsiung City, 807
About this study
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 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.
- Conditions
- Narcolepsy Type 1
- Being tested
- ALKS 2680 Dose 1, ALKS 2680 Dose 2, Placebo
- Keywords
- Brillance, Narcolepsy, Narcolepsy Type 1, Sleep Disorders, Fatigue, Cataplexy, ALKS 2680, Alixorexton, Orexin-2 receptor agonist, excessive daytime sleepiness
- Medical subject headings
- Narcolepsy, Sleep Wake Disorders, Fatigue, Cataplexy, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALKS 2680 Dose 1Drug
Also called Alixorexton
Participants will receive ALKS 2680 tablets, orally, daily, for 12 weeks
ALKS 2680 Dose 2Drug
Also called Alixorexton
Participants will receive ALKS 2680 tablets, orally, daily, for 12 weeks
PlaceboDrug
Participants will receive ALKS 2680-matching placebo tablets, orally, for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo arm Receives: Drug: Placebo |
| ALKS 2680 Dose 1 | Experimental | Oral tablet containing ALKS 2680 Receives: Drug: ALKS 2680 Dose 1 |
| ALKS 2680 Dose 2 | Experimental | Oral tablet containing ALKS 2680 Receives: Drug: ALKS 2680 Dose 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean sleep latency (MSL) on Maintenance of Wakefulness Test (MWT) from baseline to Week 12 by dose level
Measured: Baseline to Week 12
Secondary outcomes (9)
Change in Epworth Sleepiness Scale (ESS) from baseline to Week 12 by dose level
Measured: Baseline to Week 12
Weekly cataplexy rate (WCR) at Week 12 by dose level
Measured: Week 12
Percentage of participants who achieve a status of "none" or "mild" on Patient Global Impression- Severity (PGI-S) scale (general disease) at Week 12 by dose level
Measured: Week 12
Change in British Columbia Cognitive Complaints Inventory (BC-CCI) from baseline to Week 12 by dose level
Measured: Baseline to Week 12
Change in number of lapses on Psychomotor Vigilance Task (PVT) from baseline to Week 12 by dose level
Measured: Baseline to Week 12
Change in Patient-Reported Outcomes Measurement Information System - Fatigue 6a (PROMIS Fatigue 6a) from baseline to Week 12 by dose level
Measured: Baseline to Week 12
Percentage of participants who achieve a status of "normal, not ill at all", "borderline ill", or "mildly ill" on Clinical Global Impression-Severity (CGI-S) (general disease) at Week 12 by dose level
Measured: Week 12
Change in Narcolepsy Severity Scale for Clinical Trials (NSS-CT) from baseline to Week 12 by dose level
Measured: Baseline to Week 12
Incidence of treatment emergent adverse events
Measured: Up to 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start6 Apr 2026
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Narcolepsy Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alkermes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, MD, Study director, Alkermes, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07455383
- Sponsor's protocol ID
- ALKS 2680-302
- Acronym
- Brilliance NT1
- Status last verified
- Oct 2026
- First submitted
- 3 Mar 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided