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NCT07455383: Brilliance NT1
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)
Phase 3 trial testing ALKS 2680 Dose 1 in Narcolepsy Type 1 in 150 participants. Currently enrolling.
1 May 2027
Quick facts
| Lead sponsor | Alkermes, Inc. |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 150 |
| Start date | 6 April 2026 |
| Primary completion | 1 May 2027 |
| Estimated completion | 1 June 2027 |
| Sites | 17 locations across United States, Canada |
Drugs / interventions tested
- ALKS 2680 Dose 1 — full drug profile →
- ALKS 2680 Dose 2
- Placebo
Conditions studied
- Narcolepsy Type 1 — all drugs for Narcolepsy Type 1 →
Sponsor
Alkermes, Inc. — full company profile →
Who can join
Adults 18 to 70, any sex, with Narcolepsy Type 1. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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
Sponsor's own 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07455383
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Narcolepsy Type 1
Currently open trials in the same condition.
- NCT07365566 — Pain Assessment in Patients With Idiopathic REM Sleep Behaviour Disorder · NA · recruiting
- NCT07299097 — Epidemiology of Narcolepsy Type 1 and Type 2 in Spain · recruiting
- NCT07096674 — A Long-term Extension Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia · Phase 2 · recruiting
- NCT06457945 — Mind-wandering and Predictive Processes in Narcolepsy: a Putative Mechanism Through Covert REM Intrusions · NA · recruiting
- NCT06484348 — Deciphering the Interactions Between Food Intake, Sleepiness, and Nighttime Sleep Quality in Patients With Type 1 Narcol · NA · recruiting
Other Alkermes, Inc. trials
Trials by the same sponsor.
- NCT06555783 — A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2 · Phase 2 · completed
- NCT06358950 — A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (ALKS 2680-201) · Phase 2 · completed
- NCT05547100 — Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan · Phase 1 · completed
- NCT05019105 — Phase 1 ALKS 1140 in Healthy Adults · Phase 1 · terminated
- NCT04987658 — Phase 1 Study of OLZ/SAM in Pediatric Subjects With Bipolar I Disorder · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07455383 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Alkermes, Inc.
- Last refreshed: 2 June 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07455383.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing