ALKS 2680 for Narcolepsy
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ALKS 2680 tablets to measure safety, tolerability, and durability of treatment effect
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ALKS 2680
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alkermes, Inc.
Lead Sponsor
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