Clinical Trials List
Protocol NumberALKS 2680‑302
NCT Number(ClinicalTrials.gov Identfier)NCT07455383
Not yet recruiting
2026-05-01 - 2027-07-28
Phase III
Recruiting3
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
Alkermes, Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/08/30
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 吳孟霓 Division of Neurology
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Yu-Shu Huang
Co-Principal Investigator
- 金韋志 Division of Psychiatry
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Narcolepsy Type 1
Objectives
The purpose of this study is to measure decreases in daytime sleepiness, cataplexy (sudden loss of muscle tone), and disease symptoms in participants with NT1 when taking ALKS 2680 tablets compared with placebo tablets.
Test Drug
ALKS 2680
Active Ingredient
ALKS 2680
NA
NA
Dosage Form
tablet
Dosage
4 mg
6 mg
NA
6 mg
NA
Endpoints
Change in mean sleep latency on Maintenance of Wakefulness Test from baseline to Week 12 by dose level
Inclution Criteria
Inclusion Criteria:
Meets the diagnostic criteria of NT1 according to ICSD-3-TR guidelines, confirmed by diagnostic evaluations (either PSG/MSLT* or CSF hypocretin-1 level).
Meets the diagnostic criteria of NT1 according to ICSD-3-TR guidelines, confirmed by diagnostic evaluations (either PSG/MSLT* or CSF hypocretin-1 level).
Exclusion Criteria
Exclusion Criteria:
Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle.
Has a history or presence at Visit 1 of other clinically significant (treated or untreated) illness, disease, abnormality, or surgical procedure that, in the opinion of the Investigator, might compromise participant safety, interfere with any study assessment, or affect the participant's ability to complete the study.
Is currently enrolled in another interventional clinical trial or has received any investigational drug or used any interventional investigational device within 30 days prior to Visit 1. Participants previously enrolled in Study ALKS 2680-201 are not eligible for enrollment.
Is currently pregnant, breastfeeding, or is planning to become pregnant during the study
Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle.
Has a history or presence at Visit 1 of other clinically significant (treated or untreated) illness, disease, abnormality, or surgical procedure that, in the opinion of the Investigator, might compromise participant safety, interfere with any study assessment, or affect the participant's ability to complete the study.
Is currently enrolled in another interventional clinical trial or has received any investigational drug or used any interventional investigational device within 30 days prior to Visit 1. Participants previously enrolled in Study ALKS 2680-201 are not eligible for enrollment.
Is currently pregnant, breastfeeding, or is planning to become pregnant during the study
The Estimated Number of Participants
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Taiwan
4 participants
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Global
138 participants
