ALKS 2680 for Idiopathic Hypersomnia
(Vibrance-3 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 to determine if it can safely reduce daytime sleepiness in individuals with Idiopathic Hypersomnia, a condition causing excessive sleepiness despite adequate rest. Participants will receive either ALKS 2680 or a placebo (a pill with no active medicine) to compare effects. Those diagnosed with Idiopathic Hypersomnia may find this trial suitable. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
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. In an earlier study, participants taking ALKS 2680 felt more awake than those who took a placebo, a pill with no active medicine. This suggests that the treatment might be safe to use. Another study found that taking up to 50 mg of ALKS 2680 did not alter heart rhythm or heart rate, common concerns with new medicines. These results are promising for the safety of ALKS 2680, but the current trial remains focused on assessing its safety and effectiveness.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about ALKS 2680 for idiopathic hypersomnia because it represents a potential new way to tackle this challenging condition. Unlike other treatments that often focus on promoting wakefulness through stimulants, ALKS 2680 is believed to target the underlying mechanisms of excessive sleepiness. This could mean fewer side effects and a more tailored approach to managing symptoms. With dosages of 10 mg, 14 mg, and 18 mg being explored, the versatility in dosing provides a personalized treatment option that could be more effective for different patients.
What evidence suggests that ALKS 2680 could be an effective treatment for Idiopathic Hypersomnia?
Research has shown that ALKS 2680 may help treat sleep disorders. In earlier studies, ALKS 2680 helped people fall asleep faster and remain awake during the day, with greater benefits observed at higher doses. The treatment was generally well-tolerated, with doses up to 8 mg proving particularly effective. This trial will test different doses of ALKS 2680, including 10 mg, 14 mg, and 18 mg, to evaluate its effectiveness in managing idiopathic hypersomnia, a condition that causes excessive daytime sleepiness.15678
Who Is on the Research Team?
Medical Director
Principal Investigator
Alkermes, Inc.
Are You a Good Fit for This Trial?
This trial is for individuals who meet the diagnostic criteria for Idiopathic Hypersomnia according to specific guidelines, confirmed by evaluations within the last 10 years. Participants must be able to follow the study's requirements, including lifestyle restrictions and using contraception if applicable.Inclusion 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 to evaluate safety and decrease in daytime sleepiness
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