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Long-term treatment with ALKS 2680 for narcolepsy and idiopathic hypersomnia

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

Phase2; Phase3 Interventional Alkermes, Inc. · NCT06767683

This study is testing how well a new medication called ALKS 2680 works for people with narcolepsy or idiopathic hypersomnia over a long period of time.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment256 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorAlkermes, Inc. Industry-sponsored
Locations46 sites (Phoenix, Arizona and 45 other locations)
Trial IDNCT06767683 on ClinicalTrials.gov

What this trial studies

This study evaluates the long-term safety, tolerability, and effectiveness of ALKS 2680 in patients diagnosed with Narcolepsy Type 1, Narcolepsy Type 2, or Idiopathic Hypersomnia. Participants who have completed a prior study involving ALKS 2680 will receive varying doses of the medication to assess its impact over an extended period. The study aims to determine how well the treatment works in managing symptoms associated with these sleep disorders.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals who have completed a prior study involving ALKS 2680 and are diagnosed with Narcolepsy Type 1, Narcolepsy Type 2, or Idiopathic Hypersomnia.

Not a fit: Patients who are currently pregnant, breastfeeding, or have developed new significant health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from narcolepsy and idiopathic hypersomnia.

How similar studies have performed: Other studies involving similar treatments for narcolepsy have shown promise, but this specific approach with ALKS 2680 is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Was eligible for and has completed end of treatment visit of ALKS 2680 eligible parent study in NT1, NT2 or IH. The current eligible studies are ALKS 2680-201 (Vibrance-1), ALKS 2680-202 (Vibrance-2) and ALKS 2680-203 (Vibrance-3)
* Is willing and able, and in the opinion of the treating physician can safely discontinue any medications prescribed for the management of narcolepsy symptoms, as applicable, for 5 half-lives prior to Day 1 (for re-entry subjects), and for the duration of study (for all subjects)

Exclusion Criteria:

* Developed a new clinically significant health condition, ECG or laboratory abnormality, in the opinion of the Investigator or Sponsor, may impact the subject's participation in the study
* Is currently pregnant, breastfeeding, or planning to become pregnant during the study
* Is currently enrolled in another clinical study (other than the parent study) or used any investigational drug or device within 30 days prior to Screening

Where this trial is running

Phoenix, Arizona and 45 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Narcolepsy Type 1Narcolepsy Type 2Idiopathic HypersomniaNarcolepsyNT1NT2orexin-2 receptor agonistsleep
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.