Narcolepsy Type 1Phase 3NCT07540897
A Study to Evaluate the Efficacy, Safety and Tolerability of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 304)
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 20 sites in 5 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
- 20 sitesin 5 countries
- Study dates
- 13 Aug 2026to Jul 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
20 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
20 sites in 5 countries
United States15 sites, 15 recruiting
- Recruiting
Alkermes Investigational Site
Atlanta, Georgia, 30328
- 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
Colombia, South Carolina, 29201
- Recruiting
Alkermes Investigational Site
Dallas, Texas, 75251
- Recruiting
Alkermes Investigational Site
Frisco, Texas, 75033
- Recruiting
Alkermes Investigational Site
Lansing, Michigan, 48911
- Recruiting
Alkermes Investigational Site
Macon, Georgia, 31210
- Recruiting
Alkermes Investigational Site
Miami, Florida, 33176
- Recruiting
Alkermes Investigational Site
San Antonio, Texas, 78229
- Recruiting
Alkermes Investigational Site
Spokane, Washington, 99202
- Recruiting
Alkermes Investigational Site
St Louis, Missouri, 63123
- Recruiting
Alkermes Investigational Site
Sugar Land, Texas, 77478
- Recruiting
Alkermes Investigational Site
Winter Park, Florida, 32789
Canada2 sites, 2 recruiting
- Recruiting
Alkermes Investigational Site
Markham, Ontario, L3R 1A3
- Recruiting
Alkermes Investigational Site
Toronto, Ontario, M5S 3A3
Belgium1 site, 1 recruiting
- Recruiting
Alkermes Investigational Site
Diest, 3293
Japan1 site, 1 recruiting
- Recruiting
Alkermes Investigational Site
Kumamoto, 802-0084
Poland1 site, 1 recruiting
- Recruiting
Alkermes Investigational Site
Krakow, 30-105
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 304)
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
- Narcolepsy Type 1, NT1, Alixorexton, Sleepiness, Orexin-2, Orexin-2 receptor agonist, sleep disorder, excessive daytime sleepiness
- Medical subject headings
- Sleepiness, Sleep Wake Disorders, 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, daily, orally, for 12 weeks
ALKS 2680 Dose 2Drug
Also called Alixorexton
Participants will receive ALKS 2680 tablets, daily, orally, for 12 weeks
PlaceboDrug
Participants will receive placebo tablets, daily, orally for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| ALKS 2680 Dose 1 | Experimental | Not described Receives: Drug: ALKS 2680 Dose 1 |
| ALKS 2680 Dose 2 | Experimental | Not described Receives: Drug: ALKS 2680 Dose 2 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
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 baselineto 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: Baseline to Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start13 Aug 2026
- Primary completionJun 2027 (estimated)
- Study completionJul 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
- NCT07540897
- Sponsor's protocol ID
- ALKS 2680-304
- Status last verified
- Oct 2026
- First submitted
- 15 Apr 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07540897
- Acronym / sponsor ID
- ALKS 2680-304
- Conditions
- Narcolepsy Type 1
- Keywords
- Narcolepsy Type 1, NT1, Alixorexton, Sleepiness, Orexin-2, Orexin-2 receptor agonist, sleep disorder, excessive daytime sleepiness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Aug 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ALKS 2680 Dose 1 | Experimental | Drug: ALKS 2680 Dose 1 |
| ALKS 2680 Dose 2 | Experimental | Drug: ALKS 2680 Dose 2 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Meets the diagnostic criteria of NT1 according to ICSD-3-TR guidelines, confirmed by diagnostic evaluations (either PSG/MSLT* or CSF hypocretin-1 level)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALKS 2680 Dose 1Also: AlixorextonParticipants will receive ALKS 2680 tablets, daily, orally, for 12 weeks | Drug | ALKS 2680 Dose 1 |
| ALKS 2680 Dose 2Also: AlixorextonParticipants will receive ALKS 2680 tablets, daily, orally, for 12 weeks | Drug | ALKS 2680 Dose 2 |
| PlaceboParticipants will receive placebo tablets, daily, orally for 12 weeks | Drug | Placebo |
Primary outcome
Change in mean sleep latency (MSL) on Maintenance of Wakefulness Test (MWT) from baseline to Week 12 by dose level
Time frame: Baseline to Week 12
9 secondary outcomes
Change in Epworth Sleepiness Scale (ESS) from baseline to Week 12 by dose level
Time frame: Baseline to Week 12
Weekly cataplexy rate (WCR) at Week 12 by dose level
Time frame: 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
Time frame: Week 12
Change in British Columbia Cognitive Complaints Inventory (BC-CCI) from baseline to Week 12 by dose level
Time frame: Baseline to Week 12
Change in number of lapses on Psychomotor Vigilance Task (PVT) from baseline to Week 12 by dose level
Time frame: Baseline to Week 12
Change in Patient-Reported Outcomes Measurement Information System - Fatigue 6a (PROMIS Fatigue 6a) from baselineto Week 12 by dose level
Time frame: 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
Time frame: Week 12
Change in Narcolepsy Severity Scale for Clinical Trials (NSS-CT) from baseline to Week 12 by dose level
Time frame: Baseline to Week 12
Incidence of treatment emergent adverse events
Time frame: Baseline to Week 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Brilliance NT1 StudiesLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical Director, MD study director
Alkermes, Inc.
20 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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 20 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Canada, Belgium, Japan, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Director, Clinical Trial Manager (888-235-8008 (US Only), clinicaltrials@alkermes.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean sleep latency (MSL) on Maintenance of Wakefulness Test (MWT) from baseline to Week 12 by dose level (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.