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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Alkermes, Inc.
Study ID
NCT07540897
Phase
PHASE3
Status
Recruiting
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Conditions

  • Narcolepsy Type 1

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ALKS 2680 Dose 1
  • Experimental: ALKS 2680 Dose 2
  • Placebo Comparator: Placebo

Primary Outcome Measure

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 ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Alkermes Investigational SiteAtlantaGeorgia30328-
Alkermes Investigational SiteMaconGeorgia31210-
Alkermes Investigational SiteDallasTexas75251-
Alkermes Investigational SiteSan AntonioTexas78229-
Alkermes Investigational SiteSugar LandTexas77478-

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