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NCT Number: NCT07455383

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

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.

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Key information

Conditions

Narcolepsy Type 1 Cataplexy Disorders of Excessive Somnolence Dyssomnias Fatigue Mental Disorders Narcolepsy Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alkermes Investigational Site, Macquarie Park, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

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

Treatment and study plan

ALKS 2680 Dose 1

Drug

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

Other names: Alixorexton

ALKS 2680 Dose 2

Drug

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

Other names: Alixorexton

Placebo

Drug

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

Primary outcomes

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

    Time frame: Baseline to Week 12

Secondary outcomes

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

    Time frame: Baseline to Week 12

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

    Time frame: Week 12

  3. 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

    Time frame: Week 12

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

    Time frame: Baseline to Week 12

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

    Time frame: Baseline to Week 12

  6. Change in Patient-Reported Outcomes Measurement Information System - Fatigue 6a (PROMIS Fatigue 6a) from baseline to Week 12 by dose level

    Time frame: Baseline to Week 12

  7. Percentage of participants who achieve a status of "normal, not ill at all", "borderline ill", or "mildly ill" on Clinical Global Impression-Severity (CGI-S) (general disease) at Week 12 by dose level

    Time frame: Week 12

  8. Change in Narcolepsy Severity Scale for Clinical Trials (NSS-CT) from baseline to Week 12 by dose level

    Time frame: Baseline to Week 12

  9. Incidence of treatment emergent adverse events

    Time frame: Up to 14 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Director, Clinical Trial Manager

CONTACT

[email protected]

888-235-8008 (US Only)

Director, Clinical Trial Manager

CONTACT

[email protected]

571-599-2702 (Global)

Sponsors and collaborators

Lead sponsor

Alkermes, Inc.

Industry

Registry information

Official study title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 Study 302)

Acronym: Brilliance NT1

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 6, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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