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

NCT06555783 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: ALKS 2680-202
• Study Type: interventional
• Target: 93
• Locations: 8 countries
• Sites: 47

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.

Conditions

Narcolepsy Type 2

Keywords

Narcolepsy; Narcolepsy Type 2; NT2; Orexin-2 receptor agonist; Sleep; Sleep disorder; Excessive daytime sleepiness

Outcome Measures

Primary Outcomes (2)

• Change in Mean Sleep Latency (MSL) on the Maintenance Wakefulness Test (MWT)

  Baseline to Week 8

• Change in Epworth Sleepiness Scale (ESS)

  Participants will be asked to complete the ESS, reporting on the level of sleepiness they experienced over the past 7 days.

  Baseline to week 8

Secondary Outcomes (1)

• Incidence of adverse events

  Up to 21 weeks

Study Arms (4)

ALKS 2680, 10 mg

EXPERIMENTAL

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

Drug: ALKS 2680

ALKS 2680, 14 mg

EXPERIMENTAL

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

Drug: ALKS 2680

ALKS 2680, 18 mg

EXPERIMENTAL

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

Drug: ALKS 2680

Placebo

PLACEBO COMPARATOR

Oral tablet containing matching placebo for once daily administration

Drug: Placebo

Interventions

ALKS 2680 DRUG

Oral tablet containing ALKS 2680

ALKS 2680, 10 mg; ALKS 2680, 14 mg; ALKS 2680, 18 mg

Placebo DRUG

Oral tablet containing placebo for once daily administration

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alkermes, Inc.: lead

Study Sites (47)

Alkermes Investigator Site

Little Rock, Arkansas, 72211, United States

Location

Alkermes Investigator Site

Los Angeles, California, 90025, United States

Location

Alkermes Investigator Site

Redwood City, California, 94063, United States

Location

Alkermes Investigator Site

San Francisco, California, 94143, United States

Location

Alkermes Investigator Site

Santa Ana, California, 92705, United States

Location

Alkermes Investigational Site

Aurora, Colorado, 80045, United States

Location

Alkermes Investigator Site

Colorado Springs, Colorado, 80918, United States

Location

Alkermes Investigator Site

Brandon, Florida, 33511, United States

Location

Alkermes Investigator Site

Miami, Florida, 33176, United States

Location

Alkermes Investigator Site

Winter Park, Florida, 32789, United States

Location

Alkermes Investigator Site

Atlanta, Georgia, 30328, United States

Location

Alkermes Investigational Site

Macon, Georgia, 31210, United States

Location

Alkermes Investigator Site

Stockbridge, Georgia, 30281, United States

Location

Alkermes Investigational Site

Peoria, Illinois, 61637, United States

Location

Alkermes Investigator Site

Lansing, Michigan, 48911, United States

Location

Alkermes Investigator Site

Sterling Heights, Michigan, 48314, United States

Location

Alkermes Investigator Site

Lincoln, Nebraska, 68506, United States

Location

Alkermes Investigator Site

Middletown, New Jersey, 07748, United States

Location

Alkermes Investigator Site

Denver, North Carolina, 28037, United States

Location

Alkermes Investigator Site

Huntersville, North Carolina, 28078, United States

Location

Alkermes Investigator Site

Canton, Ohio, 44718, United States

Location

Alkermes Investigator Site

Cincinnati, Ohio, 45212, United States

Location

Alkermes Investigator Site

Cincinnati, Ohio, 45245, United States

Location

Alkermes Investigational Site

Cleveland, Ohio, 44195, United States

Location

Alkermes Investigator Site

Abington, Pennsylvania, 19001, United States

Location

Alkermes Investigational Site

Philadelphia, Pennsylvania, 19107, United States

Location

Alkermes Investigator Site

Wyomissing, Pennsylvania, 19610, United States

Location

Alkermes Investigator Site

Columbia, South Carolina, 29201, United States

Location

Alkermes Investigator Site

Cordova, Tennessee, 38108, United States

Location

Alkermes Investigator Site

Austin, Texas, 78731, United States

Location

Alkermes Investigator Site

San Antonio, Texas, 78229, United States

Location

Alkermes Investigational Site

Sugar Land, Texas, 77478, United States

Location

Alkermes Investigational Site

Madison, Wisconsin, 53792, United States

Location

Alkermes Investigator Site

Macquarie Park, New South Wales, 2113, Australia

Location

Alkermes Investigator Site

Bedford Park, South Australia, 5042, Australia

Location

Alkermes Investigational Site

Alken, 3570, Belgium

Location

Alkermes Investigational Site

Namur, 5101, Belgium

Location

Alkermes Investigational Site

Prague, 128 21, Czechia

Location

Alkermes Investigational Site

Bordeaux, 33076, France

Location

Alkermes Investigational Site

La Tronche, 38700, France

Location

Alkermes Investigational Site

Bologna, BO, 40139, Italy

Location

Alkermes Investigational Site

Milan, Metropolitan City Of Milan, 20132, Italy

Location

Alkermes Investigational site

Verona, 37134, Italy

Location

Alkermes Investigational Site

Zwolle, 8025BV, Netherlands

Location

Alkermes Investigational Site

Barcelona, 08036, Spain

Location

Alkermes Investigational Site

Madrid, 28036, Spain

Location

Alkermes Investigational Site

Madrid, 28043, Spain

Location

Related Links

• Vibrance-2 Study

MeSH Terms

Conditions

Narcolepsy; Sleep Wake Disorders; Disorders of Excessive Somnolence

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Medical Director, MD

  Alkermes, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 15, 2024
• Study Start: July 26, 2024
• Primary Completion: November 11, 2025
• Study Completion: November 21, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

NL (1); US (33); ES (3); FR (2); IT (3); BE (2); AU (2); CZ (1)