A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects with Narcolepsy Type 1 (ALKS 2680-201)

Launched by ALKERMES, INC. · Apr 5, 2024

Keywords

ClinConnect Summary

This clinical trial, called ALKS 2680-201, is investigating a new medication called ALKS 2680 for people with Narcolepsy Type 1, a condition that causes excessive daytime sleepiness and sudden muscle control loss, known as cataplexy. The study aims to see if ALKS 2680 is safe and effective by comparing it to a placebo, which is a treatment that does not contain any active medication. Researchers want to find out if those taking ALKS 2680 experience less daytime sleepiness and fewer episodes of cataplexy than those receiving the placebo.

To participate in this trial, individuals need to be between 18 and 70 years old, have a specific genetic marker (HLA-DQB1*06:02), and still experience excessive sleepiness and cataplexy despite their current treatment. Participants will need to stop taking any narcolepsy medications for at least two weeks before joining the study and will have to follow certain guidelines throughout the trial. This study is currently recruiting participants, and it’s a chance for those affected by Narcolepsy Type 1 to potentially access a new treatment option while contributing to important research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18-70 years of age
• • Has a BMI ≥18 and ≤40 kg/m2
• * Meets the diagnostic criteria of Narcolepsy type 1 according to ICSD-3-TR guidelines. Additionally, meets the following criteria:
• • Is HLA-DQB1\*06:02-positive
• • Has residual excessive daytime sleepiness and cataplexy
• • Is willing and able to discontinue any medications prescribed for the management of narcolepsy symptoms for at least 14 days and for the duration of study
• • Is willing to adhere to additional protocol requirements
• Exclusion Criteria:
• • Significant comorbid medical conditions, including other sleep, cardiovascular, psychiatric, hepatic or other disorders may be exclusionary; eligibility will be determined on an individual basis by the study investigator
• • Is currently pregnant, breastfeeding, or planning to become pregnant during the study
• • Is currently enrolled in another clinical study (other than the parent study) or used any investigational drug or device within 30 days prior to Screening

Trial Officials