A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2
Brilliance NT2
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2 (Brilliance NT2 Study 303)
1 other identifier
interventional
176
1 country
8
Brief Summary
The purpose of this study is to measure decreases in daytime sleepiness, and disease symptoms in participants with Narcolepsy Type 2 (NT2) when taking ALKS 2680 tablets compared with placebo tablets.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2026
Shorter than P25 for phase_3
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2026
CompletedFirst Posted
Study publicly available on registry
March 31, 2026
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
May 6, 2026
May 1, 2026
1.1 years
March 26, 2026
May 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in mean sleep latency (MSL) on Maintenance of Wakefulness Test (MWT) from baseline to Week 12 by dose level
Baseline to Week 12
Secondary Outcomes (7)
Change in Epworth Sleepiness Scale (ESS) from baseline to Week 12 by dose level
Baseline to 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
Week 12
Change in British Columbia Cognitive Complaints Inventory (BC-CCI) from baseline to Week 12 by dose level
Baseline to Week 12
Change in number of lapses on Psychomotor Vigilance Task (PVT) from baseline to Week 12 by dose level
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
Baseline to Week 12
- +2 more secondary outcomes
Study Arms (4)
ALKS 2680 Dose 1
EXPERIMENTALALKS 2680 Dose 2
EXPERIMENTALALKS 2680 Dose 3
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Participants will receive ALKS 2680 tablets, daily, orally, for 12 weeks
Participants will receive ALKS 2680 tablets, daily, orally, for 12 weeks
Participants will receive ALKS 2680 tablets, daily, orally, for 12 weeks
Eligibility Criteria
You may qualify if:
- Is willing and able, in the opinion of the Investigator, to understand and comply with protocol requirements, including the following: lifestyle considerations and restrictions, adherence to contraception guidance, adherence to actigraphy and diary requirements, if receiving treatment for OSA, adherence to primary OSA therapy over the 30 days prior to Visit 1, and throughout the study, including during overnight visits.
- Meets the diagnostic criteria of NT2 according to ICSD-3-TR guidelines, confirmed by diagnostic evaluations (either PSG/MSLT).
You may not qualify if:
- Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle.
- Has a history or presence 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 2680-202 are not eligible for enrollment.
- Is currently pregnant, breastfeeding, or is planning to become pregnant during the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alkermes, Inc.lead
Study Sites (8)
Alkermes Investigational Site
Brandon, Florida, 33511, United States
Alkermes Investigational Site
Macon, Georgia, 31210, United States
Alkermes Investigational Site
Lansing, Michigan, 48911, United States
Alkermes Investigational Site
Cincinnati, Ohio, 45245, United States
Alkermes Investigational Site
Wyomissing, Pennsylvania, 19610, United States
Alkermes Investigational Site
Columbia, South Carolina, 29201, United States
Alkermes Investigational Site
Austin, Texas, 78731, United States
Alkermes Investigational Site
Sugar Land, Texas, 77478, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director, MD
Alkermes, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2026
First Posted
March 31, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
May 6, 2026
Record last verified: 2026-05