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A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2 | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2

A Phase 2, Parallel-Group, Dose-Range-Finding Study With Randomized Double-Blind Treatment and Open-Label Periods to Evaluate the Safety and Efficacy of ALKS 2680 in Subjects With Narcolepsy Type 2

NCT06555783•Alkermes, Inc.

View on ClinicalTrials.gov

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

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 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

Locations (47)

Alkermes Investigator Site

Little Rock, Arkansas, United States

Alkermes Investigator Site

Los Angeles, California, United States

Alkermes Investigator Site

Redwood City, California, United States

Alkermes Investigator Site

San Francisco, California, United States

Alkermes Investigator Site

Santa Ana, California, United States

Alkermes Investigational Site

Aurora, Colorado, United States

Alkermes Investigator Site

Colorado Springs, Colorado, United States

Alkermes Investigator Site

Brandon, Florida, United States

Alkermes Investigator Site

Miami, Florida, United States

Alkermes Investigator Site

Winter Park, Florida, United States

Key Dates

Start Date

July 26, 2024

Primary Completion Date

November 11, 2025

Completion Date

November 21, 2025

Last Updated

February 27, 2026

Enrollment

ACTUAL participants

Conditions

Narcolepsy Type 2

Interventions

ALKS 2680

DRUG

Placebo

DRUG

A Study of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2)

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Narcolepsy Type 2

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COMPLETEDPHASE2

A Study of TAK-861 in Participants With Narcolepsy Type 2

NCT05687916

Narcolepsy Type 2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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