What is ALKS 2680 studying for narcolepsy and idiopathic hypersomnia?

ALKS 2680 is being studied to evaluate its safety, tolerability, and lasting effects in people with Narcolepsy Type 1, Narcolepsy Type 2, and Idiopathic Hypersomnia. The research aims to understand how the treatment affects sleepiness and overall health over time. Alkermes, Inc. is sponsoring this long-term study to gather important safety and effectiveness data.

Who may be eligible for this narcolepsy and idiopathic hypersomnia clinical trial?

Adults aged 18 to 70 who have completed a parent ALKS 2680 study for Narcolepsy Type 1, Narcolepsy Type 2, or Idiopathic Hypersomnia may be eligible. Participants must be able to safely stop other narcolepsy medications and are excluded if they are pregnant or in another clinical trial. Please review eligibility criteria for more details.

Is there any cost to participate in this narcolepsy and idiopathic hypersomnia clinical trial?

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

Actively Recruiting

Phase 2

Phase 3

Age: 18Years - 70Years

All Genders

ID06767683

An Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Durability of Treatment Effect of ALKS 2680 in Subjects With Narcolepsy Type 1 and Type 2 and Idiopathic Hypersomnia

Led by Alkermes, Inc. · Updated on 2026-03-04

256

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the safety, tolerability, and lasting effects of ALKS 2680 tablets in adults with Narcolepsy Type 1, Narcolepsy Type 2, or Idiopathic Hypersomnia. This open-label, long-term extension study builds on previous ALKS 2680 parent studies and aims to understand how well the treatment works over time and how safe it is for participants living with these sleep disorders. Participants will take oral tablets of ALKS 2680 once daily, with doses ranging from 4 mg to 18 mg. The study is non-randomized and includes groups of people with Narcolepsy Type 1, Narcolepsy Type 2, or Idiopathic Hypersomnia. Those joining the study may need to stop other narcolepsy medications before starting ALKS 2680 and continue taking ALKS 2680 throughout the trial. During the study, participants will be monitored for treatment side effects and changes in sleepiness using tests like the Maintenance of Wakefulness Test and the Epworth Sleepiness Scale. Researchers will track adverse events for up to 100 weeks and evaluate changes in sleep latency and sleepiness over several months. The study supports close safety monitoring and long-term follow-up from the start in early 2025 until mid-2028.

CONDITIONS

Brief Title

A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia

Who Can Participate

Age: 18Years - 70Years

All Genders

Eligibility Criteria

You may qualify if you...

Completed end of treatment visit of ALKS 2680 eligible parent study in Narcolepsy Type 1, Narcolepsy Type 2, or Idiopathic Hypersomnia
Willing and able to safely stop any narcolepsy medications for 5 half-lives prior to Day 1 (for re-entry subjects) and for the duration of the study
Aged between 18 and 70 years
Able to provide informed consent and comply with study procedures

You will not qualify if you...

Developed a new clinically significant health condition, ECG or laboratory abnormality that may impact participation
Currently pregnant, breastfeeding, or planning to become pregnant during the study
Currently enrolled in another clinical study (other than the parent study) or used any investigational drug or device within 30 days prior to screening

Research Team

Director, Global Clinical Services

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