What is ALKS 2680 studying for Narcolepsy Type 1?

ALKS 2680 is being studied to see if it can reduce daytime sleepiness, cataplexy episodes, and other symptoms in adults with Narcolepsy Type 1. Researchers want to understand how this oral medication compares to a placebo in improving these symptoms. The study is sponsored by Alkermes, Inc.

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

Adults aged 18 to 70 with a confirmed diagnosis of Narcolepsy Type 1 may be eligible. Participants should not have other sleep disorders or serious health conditions, should not be pregnant or breastfeeding, and must not be enrolled in other interventional trials 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 placebo and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 3

Age: 18Years - 70Years

All Genders

ID07455383

A Phase 3 Study to Test the Safety and Effectiveness of ALKS 2680 Tablets in Adults Aged 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

This research aims to evaluate the effects of ALKS 2680 tablets on adults with Narcolepsy Type 1 NT1. The study focuses on measuring reductions in daytime sleepiness, cataplexy sudden loss of muscle tone, and overall disease symptoms. Participants diagnosed with NT1 according to official guidelines are included to assess the impact of the treatment compared to placebo. Participants will be randomly assigned to one of three groups two different doses of ALKS 2680 or a placebo. Each participant will take oral tablets daily for 12 weeks. The study is designed as a phase 3, randomized, double-blind, placebo-controlled trial to thoroughly evaluate the drugs efficacy and safety during this period. During the study, participants will undergo assessments including the Maintenance of Wakefulness Test to measure sleep latency, along with various scales and inventories to evaluate sleepiness, cataplexy rates, cognitive complaints, fatigue, and narcolepsy severity. Safety will be monitored through reports of adverse events over approximately 14 weeks. The total participation time spans the 12-week treatment period and follow-up for safety monitoring.

CONDITIONS

Brief Title

A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1

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 according to ICSD-3-TR guidelines
Diagnosis confirmed by PSG/MSLT or CSF hypocretin-1 level

You will not qualify if you...

Has another sleep disorder or condition affecting the sleep-wake cycle
Has other significant illness, disease, abnormality, or recent surgery that may affect safety or study completion
Currently enrolled in another interventional clinical trial or used investigational drugs/devices within 30 days prior to enrollment
Previously enrolled in Study ALKS 2680-201
Currently pregnant, breastfeeding, or planning pregnancy during the study

Research Team

Director, Clinical Trial Manager

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