What is ALKS 2680 studying for Narcolepsy Type 1?

ALKS 2680 is being studied to see if it can reduce daytime sleepiness, cataplexy, and other symptoms in adults with Narcolepsy Type 1. This Phase 3 trial compares two doses of ALKS 2680 tablets to placebo tablets to evaluate their effects on these symptoms. The study is sponsored by Alkermes, Inc. to better understand treatment options for this condition.

Who may be eligible for this Narcolepsy Type 1 clinical trial?

Adults aged 18 to 70 years with a confirmed diagnosis of Narcolepsy Type 1 may be eligible. Participants should not have other sleep disorders, be currently pregnant or breastfeeding, or be enrolled in another interventional trial recently. Please review eligibility criteria for more details.

Is there any cost to participate in this Narcolepsy Type 1 clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses to attend study visits may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 3

Age: 18Years - 70Years

All Genders

ID07540897

Evaluation of ALKS 2680 Tablets to Reduce Sleepiness and Cataplexy in Adults 18 to 70 with Narcolepsy Type 1

Led by Alkermes, Inc. · Updated on 2026-08-07

150

Participants Needed

Research Sites

4 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of ALKS 2680 tablets on adults aged 18 to 70 with Narcolepsy Type 1 NT1, a condition characterized by excessive daytime sleepiness and sudden muscle weakness called cataplexy. This Phase 3 clinical trial aims to measure how ALKS 2680 compares with placebo tablets in reducing these symptoms and improving overall disease severity. Participants receive either one of two doses of ALKS 2680 or a placebo, taking their assigned tablets daily by mouth for 12 weeks. The study uses a randomized, parallel-group design with triple masking to compare these treatments. During this period, researchers monitor changes in sleepiness, cataplexy frequency, cognitive complaints, fatigue, and overall clinical impressions. Participants will undergo various assessments including the Maintenance of Wakefulness Test, Epworth Sleepiness Scale, cataplexy rate tracking, and multiple patient-reported outcome measures. Safety is monitored throughout the study, with treatment-emergent adverse events recorded up to two weeks after the treatment period. The total participation spans approximately 12 weeks of treatment and evaluation.

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

Age: 18Years - 70Years

All Genders

Eligibility Criteria

You may qualify if you...

Adults aged 18 to 70 years
Diagnosed with Narcolepsy Type 1 following ICSD-3-TR guidelines
Diagnosis confirmed by polysomnography/multiple sleep latency test or cerebrospinal fluid hypocretin-1 levels

You will not qualify if you...

Presence of other sleep disorders or conditions affecting the sleep-wake cycle
History or presence of significant illness, disease, abnormality, or recent surgery that may affect safety or study participation
Currently enrolled in another interventional clinical trial or used investigational drugs/devices within 30 days prior to study start
Pregnant, breastfeeding, or planning pregnancy during the study

Research Team

Director, Clinical Trial Manager

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