A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (ALKS 2680-201)
About the study
The purpose of this research study is to assess the safety and efficacy of ALKS 2680 compared to placebo, including whether participants taking ALKS 2680 experience a greater decrease in sleepiness and a decrease in cataplexy ("sudden loss of muscle control"), compared to participants taking placebo alone.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- * 18-70 years of age
- * Has a BMI ≥18 and ≤35 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
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
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Narcolepsy Type 1
Age (in years)
18 - 70
Phase
PHASE2
Participants Needed
80
Est. Completion Date
Jul 31, 2025
Treatment Type
INTERVENTIONAL
Sponsor
Alkermes, Inc.
ClinicalTrials.gov NCT Identifier
NCT06358950
Study Number
ALKS 2680-201
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