A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1

NCT07455383 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: ALKS 2680-302
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Narcolepsy Type 1

Keywords

Brillance; Narcolepsy; Narcolepsy Type 1; Sleep Disorders; Fatigue; Cataplexy; ALKS 2680; Alixorexton; Orexin-2 receptor agonist; excessive daytime sleepiness

Outcome Measures

Primary Outcomes (1)

• Change in mean sleep latency (MSL) on Maintenance of Wakefulness Test (MWT) from baseline to Week 12 by dose level

  Baseline to Week 12

Secondary Outcomes (9)

• Change in Epworth Sleepiness Scale (ESS) from baseline to Week 12 by dose level

  Baseline to Week 12

• Weekly cataplexy rate (WCR) at Week 12 by dose level

  Week 12

• Percentage of participants who achieve a status of "none" or "mild" on Patient Global Impression- Severity (PGI-S) scale (general disease) at Week 12 by dose level

  Week 12

• Change in British Columbia Cognitive Complaints Inventory (BC-CCI) from baseline to Week 12 by dose level

  Baseline to Week 12

• Change in number of lapses on Psychomotor Vigilance Task (PVT) from baseline to Week 12 by dose level

  Baseline to Week 12

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo arm

Drug: Placebo

ALKS 2680 Dose 1

EXPERIMENTAL

Oral tablet containing ALKS 2680

Drug: ALKS 2680 Dose 1

ALKS 2680 Dose 2

EXPERIMENTAL

Oral tablet containing ALKS 2680

Drug: ALKS 2680 Dose 2

Interventions

ALKS 2680 Dose 1 DRUG

Participants will receive ALKS 2680 tablets, orally, daily, for 12 weeks

Also known as: Alixorexton

ALKS 2680 Dose 1

ALKS 2680 Dose 2 DRUG

Participants will receive ALKS 2680 tablets, orally, daily, for 12 weeks

Also known as: Alixorexton

ALKS 2680 Dose 2

Placebo DRUG

Participants will receive ALKS 2680-matching placebo tablets, orally, for 12 weeks.

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:

• Meets the diagnostic criteria of NT1 according to ICSD-3-TR guidelines, confirmed by diagnostic evaluations (either PSG/MSLT\* or CSF hypocretin-1 level).

You may not qualify if:

• 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

Sponsors & Collaborators

• Alkermes, Inc.: lead

Study Sites (9)

Alkermes Investigational Site

Brandon, Florida, 33511, United States

RECRUITING

Alkermes Investigational Site

Macon, Georgia, 31210, United States

RECRUITING

Alkermes Investigational Site

Lansing, Michigan, 48911, United States

RECRUITING

Alkermes Investigational Site

St Louis, Missouri, 63123, United States

RECRUITING

Alkermes Investigational Site

Cincinnati, Ohio, 45245, United States

RECRUITING

Alkermes Investigational Site

Wyomissing, Pennsylvania, 19610, United States

RECRUITING

Alkermes Investigational Site

Columbia, South Carolina, 29201, United States

RECRUITING

Alkermes Investigational Site

Austin, Texas, 78731, United States

RECRUITING

Alkermes Investigational Site

Sugar Land, Texas, 77478, United States

RECRUITING

MeSH Terms

Conditions

Narcolepsy; Sleep Wake Disorders; Fatigue; Cataplexy; 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

Central Study Contacts

Director, Clinical Trial Manager

CONTACT

888-235-8008 (US Only); clinicaltrials@alkermes.com

Director, Clinical Trial Manager

CONTACT

571-599-2702 (Global); clinicaltrials@alkermes.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 6, 2026
• Study Start: April 6, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

US (9)