ALKS 2680 for Narcolepsy
(Vibrance-2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new tablet, ALKS 2680, to determine if it can reduce sleepiness in people with narcolepsy type 2. Researchers aim to ensure the tablets are safe and to compare their effects against a placebo (a pill with no active medicine). The trial includes different groups that will receive varying doses of the tablet or a placebo. Individuals with narcolepsy type 2 who experience ongoing daytime sleepiness and are willing to stop other narcolepsy medications for the trial might be suitable candidates. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
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. Earlier studies with single doses up to 8 mg improved sleep without major side effects. Other studies in healthy adults and people with narcolepsy also found ALKS 2680 to be safe. This trial uses higher doses (10, 14, and 18 mg), but earlier research indicates its safety. As a Phase 2 trial, ALKS 2680 has already passed initial safety tests. This suggests the treatment is likely safe, but this trial will help confirm that.12345
Why do researchers think this study treatment might be promising for narcolepsy?
Researchers are excited about ALKS 2680 for narcolepsy because it offers a new approach with its unique formulation. Unlike standard treatments like modafinil or sodium oxybate, which primarily target wakefulness, ALKS 2680 is designed as an oral tablet that may work differently by potentially modulating neurotransmitter systems in novel ways. This could lead to improved wakefulness and reduced daytime sleepiness with possibly fewer side effects. By offering different dosages (10 mg, 14 mg, and 18 mg), ALKS 2680 provides flexibility in treatment, which could be tailored to individual patient needs.
What evidence suggests that ALKS 2680 might be an effective treatment for narcolepsy?
Research shows that ALKS 2680, also known as alixorexton, may help people with narcolepsy type 1 stay awake. Studies have found that it significantly improves alertness and reduces daytime sleepiness. This treatment affects orexin receptors in the brain, which control sleep and wakefulness. Previous users have generally responded well and tolerated it without major issues. These results suggest that ALKS 2680 might also help manage symptoms of narcolepsy type 2. Participants in this trial will receive different dosages of ALKS 2680 or a placebo to further evaluate its effectiveness and safety.12367
Who Is on the Research Team?
Medical Director, MD
Principal Investigator
Alkermes, Inc.
Are You a Good Fit for This Trial?
This trial is for individuals with narcolepsy type 2. Specific eligibility criteria are not provided, but typically participants must meet certain health conditions and agree to the study's procedures.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 tablets daily to evaluate safety and decrease in sleepiness
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
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