256 Participants Needed

ALKS 2680 for Narcolepsy

Recruiting at 43 trial locations
DG
Overseen ByDirector, Global Clinical Services
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: Alkermes, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ALKS 2680 for individuals with sleep disorders such as Narcolepsy Type 1, Narcolepsy Type 2, and Idiopathic Hypersomnia (characterized by excessive daytime sleepiness without a known cause). The trial aims to assess the safety and effectiveness of this treatment over time. It is designed for those who have already participated in a related study and can safely discontinue other narcolepsy medications. Participants should have experience with frequent sleep attacks or excessive daytime sleepiness. As a Phase 3 trial, this treatment represents the final step before FDA approval, offering participants a chance to contribute to its potential availability for wider use.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any medications prescribed for managing narcolepsy symptoms for a certain period before starting the trial and for the entire duration of the study.

Is there any evidence suggesting that ALKS 2680 is likely to be safe for humans?

Research has shown that ALKS 2680 is likely safe. In earlier studies, most participants tolerated ALKS 2680 well. They felt more awake compared to those who took a placebo, experiencing increased alertness without serious side effects. Another study found the treatment safe for both healthy adults and those with conditions like narcolepsy or idiopathic hypersomnia, which cause excessive daytime sleepiness. So far, evidence suggests ALKS 2680 could be a safe option for treating sleep disorders.12345

Why do researchers think this study treatment might be promising for narcolepsy?

Unlike the standard treatments for narcolepsy, which typically include medications like modafinil or sodium oxybate, ALKS 2680 offers a novel approach. This treatment works through a unique mechanism of action, targeting specific receptors in the brain to improve wakefulness. Researchers are excited about ALKS 2680 because it could potentially offer faster results and fewer side effects compared to existing options. Additionally, its potential effectiveness in treating both types of narcolepsy and idiopathic hypersomnia makes it a versatile option for patients with different sleep disorders.

What evidence suggests that ALKS 2680 might be an effective treatment for narcolepsy?

Research has shown that ALKS 2680, also known as alixorexton, may help treat sleep disorders such as narcolepsy. In this trial, participants with Narcolepsy Type 1, Narcolepsy Type 2, or Idiopathic Hypersomnia will receive ALKS 2680. Studies have found that it significantly improves wakefulness and reduces daytime sleepiness in people with Narcolepsy Type 1. The treatment activates certain receptors in the brain that promote wakefulness. Early results suggest that ALKS 2680 is safe and more effective than a placebo at improving alertness. This makes it a potential option for those experiencing excessive sleepiness due to narcolepsy or idiopathic hypersomnia.12678

Who Is on the Research Team?

MD

Medical Director

Principal Investigator

Alkermes, Inc.

Are You a Good Fit for This Trial?

This trial is for people with Narcolepsy Type 1 or Type 2 who finished a previous ALKS 2680 study. They must be able to stop other narcolepsy meds safely and can't join if they're pregnant, breastfeeding, planning pregnancy, have new health issues, or are in another study.

Inclusion Criteria

Was eligible for and has completed end of treatment visit of ALKS 2680 eligible parent study in NT1 or NT2. The current eligible studies are ALKS 2680-201 (Vibrance-1) and ALKS 2680-202 (Vibrance-2)
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
I am not in another clinical study or haven't used experimental drugs or devices in the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ALKS 2680 tablets to measure safety, tolerability, and durability of treatment effect

Long-term

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ALKS 2680
Trial Overview The trial tests the long-term effects of different doses of ALKS 2680 tablets on safety and treatment durability for narcolepsy. Participants previously involved in specific ALKS studies will continue their treatment at varying dosages.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Narcolepsy Type 2 (NT2)Experimental Treatment3 Interventions
Group II: Narcolepsy Type 1 (NT1)Experimental Treatment3 Interventions
Group III: Idiopathic Hypersomnia (IH)Experimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Alkermes, Inc.

Lead Sponsor

Trials
118
Recruited
27,200+

Richard Pops

Alkermes, Inc.

Chief Executive Officer since 1991

BA in Economics from Stanford University

Dr. Craig Hopkinson

Alkermes, Inc.

Chief Medical Officer since 2017

MD

Published Research Related to This Trial

In a multicenter trial involving 285 patients with narcolepsy, sodium oxybate significantly improved quality of life, as measured by the Functional Outcomes of Sleep Questionnaire, compared to placebo.
The improvements were dose-related, with notable enhancements in various aspects of daily functioning, including activity level and social outcomes, indicating that sodium oxybate can effectively address symptoms of narcolepsy.
A randomized trial evaluating the effectiveness of sodium oxybate therapy on quality of life in narcolepsy.Weaver, TE., Cuellar, N.[2019]
Narcolepsy affects a small percentage of the population and is linked to genetic factors and the loss of hypocretin-producing neurons, suggesting an autoimmune component that may be triggered by environmental factors.
Current treatments like sodium oxybate and modafinil effectively manage symptoms such as excessive daytime sleepiness and cataplexy, while emerging therapies focus on both non-hypocretin-based and hypocretin-based approaches to improve outcomes for patients.
New developments in the management of narcolepsy.Abad, VC., Guilleminault, C.[2020]
In the phase 3 REST-ON trial involving 222 narcolepsy patients, the once-nightly formulation of sodium oxybate (ON-SXB) showed significant improvements in sleep latency, cataplexy attacks, and overall clinical improvement compared to placebo, with all results being statistically significant (p < 0.001).
The safety profile of ON-SXB was consistent with existing sodium oxybate treatments, with common side effects including nausea, vomiting, and dizziness, indicating that ON-SXB is a safe and effective option for managing narcolepsy symptoms.
Once-nightly sodium oxybate (FT218) demonstrated improvement of symptoms in a phase 3 randomized clinical trial in patients with narcolepsy.Kushida, CA., Shapiro, CM., Roth, T., et al.[2023]

Citations

World Sleep 2025: Alixorexton (ALKS 2680) Narcolepsy ...Our prepared remarks today will include data from our Vibrance-1 phase 2 clinical trial for alixorexton, formerly. Page 2. 2 known as ALKS 2680.
Alkermes to Present Positive Clinical Data From Phase 1b ...As previously announced, ALKS 2680 was generally well tolerated with improved wakefulness compared to placebo in both cohorts. "Results from the ...
The Orexin 2 Receptor Agonist ALKS 2680 in Patients with ...To present the results from a randomized, double-blind, phase 1b study assessing the safety, tolerability, and pharmacodynamics of ALKS 2680 in ...
Orexin Receptor Agent ALKS 2680 Meets End Points in ...New study reveals that alixorexton significantly improves wakefulness and reduces daytime sleepiness in narcolepsy type 1, paving the way ...
0830 Effects of the Orexin 2 Receptor Agonist ALKS 2680 on ...ALKS 2680 is a highly potent, orally bioavailable, and selective orexin 2 receptor agonist being developed as a once-daily treatment for narcolepsy and ...
ISRCTN98204977: A study in healthy subjects to see the ...This is a clinical study to assess how safe and well tolerated an investigational drug (ALKS 2680) is in healthy adults and adults with narcolepsy or idiopathic ...
Vibrance-3: Study Design and Methods for a Phase 2 ...This complements ongoing studies of ALKS 2680 in patients with narcolepsy type 1 and type 2. The primary endpoint is change in Epworth ...
O013 Preliminary Results from a Phase 1 Study of ALKS ...ALKS 2680, a potent, brain-penetrant, highly selective orexin-2 receptor (OX2R) agonist, is being developed for treatment of narcolepsy and other hypersomnias.
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