Status:
ACTIVE_NOT_RECRUITING
A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2
Lead Sponsor:
Alkermes, Inc.
Conditions:
Narcolepsy Type 2
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to measure the safety and decrease in sleepiness in subjects with narcolepsy type 2 (NT2) when taking ALKS 2680 tablets compared to placebo tablets.
Eligibility Criteria
Inclusion
- 18-70 years of age
- Has a BMI ≥18 and ≤40 kg/m2
- Meets the diagnostic criteria of Narcolepsy type 2 according to ICSD-3-TR guidelines.
- Additionally, meets the following criteria:
- Has residual excessive daytime sleepiness
- 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
- 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
Key Trial Info
Start Date :
July 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06555783
Start Date
July 26 2024
End Date
November 1 2025
Last Update
September 24 2025
Active Locations (47)
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1
Alkermes Investigator Site
Little Rock, Arkansas, United States, 72211
2
Alkermes Investigator Site
Los Angeles, California, United States, 90025
3
Alkermes Investigator Site
Redwood City, California, United States, 94063
4
Alkermes Investigator Site
San Francisco, California, United States, 94143