Actively Recruiting
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1
Led by Alkermes, Inc. · Updated on 2026-05-27
150
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of ALKS 2680 tablets on adults with Narcolepsy Type 1 (NT1), a condition characterized by excessive daytime sleepiness and sudden muscle weakness called cataplexy. This Phase 3 trial aims to evaluate changes in these symptoms and overall disease severity compared to placebo tablets. The study is sponsored by Alkermes, Inc. and uses a randomized, double-blind design to measure treatment impact. Participants will be randomly assigned to receive one of two dose levels of ALKS 2680 tablets or placebo tablets. The medication is taken daily by mouth for 12 weeks. The study compares these groups to see how ALKS 2680 influences sleep latency, daytime sleepiness, cataplexy frequency, and other symptoms related to NT1. During the 12-week treatment period, participants will undergo tests such as the Maintenance of Wakefulness Test and complete questionnaires including the Epworth Sleepiness Scale and Patient Global Impression-Severity. Researchers will also monitor cognitive complaints, fatigue, and overall clinical impressions. Safety is assessed through tracking adverse events up to 14 weeks. The total participation duration includes baseline assessments and follow-ups to evaluate treatment effects.
CONDITIONS
Brief Title
A Study to Evaluate the Efficacy, Safety and Tolerability of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 304)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 70 years
- Diagnosed with Narcolepsy Type 1 according to ICSD-3-TR guidelines
- Diagnosis confirmed by PSG/MSLT or cerebrospinal fluid hypocretin-1 level
You will not qualify if you...
- Have another sleep disorder or condition affecting the sleep-wake cycle
- Have other significant illnesses or conditions that could affect safety or study assessments
- Currently enrolled in another interventional clinical trial or used investigational drugs/devices within 30 days prior to Visit 1
- Previously enrolled in Study ALKS 2680-201
- Are pregnant, breastfeeding, or planning pregnancy during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive daily oral tablets of ALKS 2680 or placebo for 12 weeks.
Weekly visits for up to 12 weeks
Duration - 2 weeks
Participants are monitored for safety and treatment emergent adverse events after treatment ends.
1 to 2 visits
Trial Site Locations
Total: 1 location
1
Alkermes Investigational Site
Atlanta, Georgia, United States, 30328
Actively Recruiting
Research Team
D
Director, Clinical Trial Manager
D
Director, Clinical Trial Manager
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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