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Recruiting NCT07540897

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

Phase III Interventional Narcolepsy Type 1

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ALKS 2680 Dose 1, ALKS 2680 Dose 2, Placebo.
Who it may be relevant to
Registry conditions: Narcolepsy Type 1. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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 304)

Overview

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.

Interventions

  • Drug ALKS 2680 Dose 1
    Participants will receive ALKS 2680 tablets, daily, orally, for 12 weeks
  • Drug ALKS 2680 Dose 2
    Participants will receive ALKS 2680 tablets, daily, orally, for 12 weeks
  • Drug Placebo
    Participants will receive placebo tablets, daily, orally for 12 weeks

Primary outcome measures

  • 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 outcome measures (9)
  • Change in Epworth Sleepiness Scale (ESS) from baseline to Week 12 by dose level [Time frame: Baseline to Week 12]
  • Weekly cataplexy rate (WCR) at Week 12 by dose level [Time frame: 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 [Time frame: Week 12]
  • Change in British Columbia Cognitive Complaints Inventory (BC-CCI) from baseline to Week 12 by dose level [Time frame: Baseline to Week 12]
  • Change in number of lapses on Psychomotor Vigilance Task (PVT) from baseline to Week 12 by dose level [Time frame: Baseline to Week 12]
  • Change in Patient-Reported Outcomes Measurement Information System - Fatigue 6a (PROMIS Fatigue 6a) from baselineto Week 12 by dose level [Time frame: 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 [Time frame: Week 12]
  • Change in Narcolepsy Severity Scale for Clinical Trials (NSS-CT) from baseline to Week 12 by dose level [Time frame: Baseline to Week 12]
  • Incidence of treatment emergent adverse events [Time frame: Baseline to Week 14]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 12 centers
  • Alkermes Investigational Site — Miami
  • Alkermes Investigational Site — Winter Park
  • Alkermes Investigational Site — Atlanta
  • Alkermes Investigational Site — Macon
  • Alkermes Investigational Site — Lansing
  • Alkermes Investigational Site — St Louis
  • Alkermes Investigational Site — Charlotte
  • Alkermes Investigational Site — Cincinnati
  • … and 4 more centers
Canada · 2 centers
  • Alkermes Investigational Site — Markham
  • Alkermes Investigational Site — Toronto

Identifiers

NCT: NCT07540897 · ALKS 2680-304

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗