ALKS 2680 for Narcolepsy
(Vibrance-1 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 people with narcolepsy, a condition that often causes excessive daytime sleepiness and cataplexy (sudden loss of muscle control). The goal is to determine if ALKS 2680 can reduce these symptoms more effectively than a placebo. The trial will explore different doses of the medication to identify the most effective one. People diagnosed with narcolepsy type 1 who still experience sleepiness and cataplexy, despite treatment, might be suitable candidates for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people, offering participants a chance to contribute to important medical advancements.
Do I need to stop my current medications for this trial?
Yes, you will need to stop taking any medications prescribed for managing narcolepsy symptoms for at least 14 days before the study and throughout its duration.
Is there any evidence suggesting that ALKS 2680 is likely to be safe for humans?
Research has shown that ALKS 2680 is generally safe for people. Studies have found that single doses up to 8 mg are not only safe but also help reduce symptoms of narcolepsy, such as sleepiness and sudden muscle weakness (cataplexy). Earlier trials with both healthy adults and those with narcolepsy reported no serious safety issues. Overall, the treatment appears safe based on current data, with improvements observed in sleep-related problems.12345
Why do researchers think this study treatment might be promising for narcolepsy?
Researchers are excited about ALKS 2680 for narcolepsy because it introduces a potentially novel mechanism of action compared to standard treatments like modafinil, sodium oxybate, or pitolisant. ALKS 2680 might work differently by targeting specific pathways in the brain that are not the primary focus of current medications. This could lead to improved wakefulness with fewer side effects. Additionally, having multiple dosing options (4 mg, 6 mg, and 8 mg) allows for more personalized treatment, potentially tailoring therapy to meet individual patient needs effectively.
What evidence suggests that ALKS 2680 might be an effective treatment for narcolepsy?
Research shows that ALKS 2680, also known as alixorexton, can significantly help people with narcolepsy type 1 stay awake. This trial will evaluate different dosages of ALKS 2680—4 mg, 6 mg, and 8 mg—alongside a placebo. This treatment has effectively reduced daytime sleepiness, a key symptom of narcolepsy. In earlier studies, participants became more alert and experienced fewer episodes of cataplexy, a sudden loss of muscle control. ALKS 2680 works by affecting the orexin system in the brain, which manages sleep and wakefulness. Data indicate that the treatment is generally well tolerated.12367
Who Is on the Research Team?
Study Medical Director, MD
Principal Investigator
Alkermes, Inc.
Are You a Good Fit for This Trial?
This trial is for individuals with Narcolepsy Type 1, a condition causing excessive daytime sleepiness and sometimes sudden muscle weakness. Participants should be diagnosed with this type of narcolepsy to qualify.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 or placebo to assess safety and efficacy, focusing on sleepiness and cataplexy reduction
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