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

NCT ID: NCT06555783

Last Updated: 2025-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-26

Study Completion Date

2025-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Narcolepsy Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ALKS 2680, 10 mg

Oral tablet containing 10mg of ALKS 2680 for once daily administration

Group Type EXPERIMENTAL

ALKS 2680

Intervention Type DRUG

Oral tablet containing ALKS 2680

ALKS 2680, 14 mg

Oral tablet containing 14mg of ALKS 2680 for once daily administration

Group Type EXPERIMENTAL

ALKS 2680

Intervention Type DRUG

Oral tablet containing ALKS 2680

ALKS 2680, 18 mg

Oral tablet containing 18mg of ALKS 2680 for once daily administration

Group Type EXPERIMENTAL

ALKS 2680

Intervention Type DRUG

Oral tablet containing ALKS 2680

Placebo

Oral tablet containing matching placebo for once daily administration

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral tablet containing placebo for once daily administration

Interventions

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ALKS 2680

Oral tablet containing ALKS 2680

Intervention Type DRUG

Placebo

Oral tablet containing placebo for once daily administration

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alkermes, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director, MD

Role: STUDY_DIRECTOR

Alkermes, Inc.

Locations

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Alkermes Investigator Site

Little Rock, Arkansas, United States

Site Status

Alkermes Investigator Site

Los Angeles, California, United States

Site Status

Alkermes Investigator Site

Redwood City, California, United States

Site Status

Alkermes Investigator Site

San Francisco, California, United States

Site Status

Alkermes Investigator Site

Santa Ana, California, United States

Site Status

Alkermes Investigational Site

Aurora, Colorado, United States

Site Status

Alkermes Investigator Site

Colorado Springs, Colorado, United States

Site Status

Alkermes Investigator Site

Brandon, Florida, United States

Site Status

Alkermes Investigator Site

Miami, Florida, United States

Site Status

Alkermes Investigator Site

Winter Park, Florida, United States

Site Status

Alkermes Investigator Site

Atlanta, Georgia, United States

Site Status

Alkermes Investigational Site

Macon, Georgia, United States

Site Status

Alkermes Investigator Site

Stockbridge, Georgia, United States

Site Status

Alkermes Investigational Site

Peoria, Illinois, United States

Site Status

Alkermes Investigator Site

Lansing, Michigan, United States

Site Status

Alkermes Investigator Site

Sterling Heights, Michigan, United States

Site Status

Alkermes Investigator Site

Lincoln, Nebraska, United States

Site Status

Alkermes Investigator Site

Middletown, New Jersey, United States

Site Status

Alkermes Investigator Site

Denver, North Carolina, United States

Site Status

Alkermes Investigator Site

Huntersville, North Carolina, United States

Site Status

Alkermes Investigator Site

Canton, Ohio, United States

Site Status

Alkermes Investigator Site

Cincinnati, Ohio, United States

Site Status

Alkermes Investigator Site

Cincinnati, Ohio, United States

Site Status

Alkermes Investigational Site

Cleveland, Ohio, United States

Site Status

Alkermes Investigator Site

Abington, Pennsylvania, United States

Site Status

Alkermes Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

Alkermes Investigator Site

Wyomissing, Pennsylvania, United States

Site Status

Alkermes Investigator Site

Columbia, South Carolina, United States

Site Status

Alkermes Investigator Site

Austin, Texas, United States

Site Status

Alkermes Investigator Site

San Antonio, Texas, United States

Site Status

Alkermes Investigational Site

Sugar Land, Texas, United States

Site Status

Alkermes Investigator Site

Sugarland, Texas, United States

Site Status

Alkermes Investigational Site

Madison, Wisconsin, United States

Site Status

Alkermes Investigator Site

Macquarie Park, New South Wales, Australia

Site Status

Alkermes Investigator Site

Bedford Park, South Australia, Australia

Site Status

Alkermes Investigational Site

Alken, , Belgium

Site Status

Alkermes Investigational Site

Namur, , Belgium

Site Status

Alkermes Investigational Site

Prague, , Czechia

Site Status

Alkermes Investigational Site

Bordeaux, Bordeaux, France

Site Status

Alkermes Investigational Site

La Tronche, LA Tronche, France

Site Status

Alkermes Investigational Site

Bologna, BO, Italy

Site Status

Alkermes Investigational Site

Milan, Metropolitan City of Milan, Italy

Site Status

Alkermes Investigational site

Verona, , Italy

Site Status

Alkermes Investigational Site

Zwolle, , Netherlands

Site Status

Alkermes Investigational Site

Barcelona, , Spain

Site Status

Alkermes Investigational Site

Madrid, , Spain

Site Status

Alkermes Investigational Site

Madrid, , Spain

Site Status

Countries

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United States Australia Belgium Czechia France Italy Netherlands Spain

Related Links

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https://vibrancestudies.com/?utm_source=ClinicalTrials&utm_medium=Referral&utm_content=Listing&utm_campaign=Listing_Vibrance2

Vibrance-2 Study

Other Identifiers

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ALKS 2680-202

Identifier Type: -

Identifier Source: org_study_id

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