A Study to Evaluate the Efficacy, Safety and Tolerability of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 304)

NCT07540897 — Phase 3, Recruiting, 150 participants, Alkermes, Inc.

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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 304)

RegistryNCT07540897
StatusRecruiting
PhasePhase 3
Study typeInterventional; randomized, parallel, masking: triple, treatment
Enrollment150 (Estimated)
SponsorAlkermes, Inc. (Industry)
ConditionsNarcolepsy Type 1
InterventionsALKS 2680 Dose 1, ALKS 2680 Dose 2, Placebo (Drug)
Datesstart 2026-08-13, primary completion 2027-06-01 (estimated), completion 2027-07-01 (estimated), first posted 2026-04-21, last updated 2026-10-07
Locations20 sites in United States, Belgium, Canada, Japan, Poland

Related Papers Related Patents Related Grants Related Experts
All trials for Narcolepsy Type 1 All trials of ALKS 2680 Dose 1 All trials of ALKS 2680 Dose 2

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
ALKS 2680 Dose 1ExperimentalDrug: ALKS 2680 Dose 1
ALKS 2680 Dose 2ExperimentalDrug: ALKS 2680 Dose 2
PlaceboPlacebo comparatorDrug: Placebo
  • ALKS 2680 Dose 1 (Drug), also known as Alixorexton: Participants will receive ALKS 2680 tablets, daily, orally, for 12 weeks
  • ALKS 2680 Dose 2 (Drug), also known as Alixorexton: Participants will receive ALKS 2680 tablets, daily, orally, for 12 weeks
  • Placebo (Drug): Participants will receive placebo tablets, daily, orally for 12 weeks

+Outcome measures

Primary outcomes

  • 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

  • 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]
  • Change in Patient-Reported Outcomes Measurement Information System - Fatigue 6a (PROMIS Fatigue 6a) from baselineto Week 12 by dose level [Baseline to Week 12]
  • 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 [Week 12]
  • Change in Narcolepsy Severity Scale for Clinical Trials (NSS-CT) from baseline to Week 12 by dose level [Baseline to Week 12]
  • Incidence of treatment emergent adverse events [Baseline to Week 14]

+Eligibility

Sex: All, ages: 18 Years to 70 Years

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.

+Locations (20)

FacilityCityCountryStatus
Alkermes Investigational SiteBrandon, FloridaUnited StatesRecruiting
Alkermes Investigational SiteMiami, FloridaUnited StatesRecruiting
Alkermes Investigational SiteWinter Park, FloridaUnited StatesRecruiting
Alkermes Investigational SiteAtlanta, GeorgiaUnited StatesRecruiting
Alkermes Investigational SiteMacon, GeorgiaUnited StatesRecruiting
Alkermes Investigational SiteLansing, MichiganUnited StatesRecruiting
Alkermes Investigational SiteSt Louis, MissouriUnited StatesRecruiting
Alkermes Investigational SiteCharlotte, North CarolinaUnited StatesRecruiting
Alkermes Investigational SiteCincinnati, OhioUnited StatesRecruiting
Alkermes Investigational SiteColombia, South CarolinaUnited StatesRecruiting
Alkermes Investigational SiteDallas, TexasUnited StatesRecruiting
Alkermes Investigational SiteFrisco, TexasUnited StatesRecruiting
Alkermes Investigational SiteSan Antonio, TexasUnited StatesRecruiting
Alkermes Investigational SiteSugar Land, TexasUnited StatesRecruiting
Alkermes Investigational SiteSpokane, WashingtonUnited StatesRecruiting
Alkermes Investigational SiteDiestBelgiumRecruiting
Alkermes Investigational SiteMarkham, OntarioCanadaRecruiting
Alkermes Investigational SiteToronto, OntarioCanadaRecruiting
Alkermes Investigational SiteKumamotoJapanRecruiting
Alkermes Investigational SiteKrakowPolandRecruiting

+Investigators

  • Medical Director, MD, Study director, Alkermes, Inc.