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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Alkermes, Inc.
Study ID
NCT07455383
Phase
PHASE3
Status
Recruiting
Apply to this trial

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, orally, daily, for 12 weeks
  • ALKS 2680 Dose 2 — DRUG
    Participants will receive ALKS 2680 tablets, orally, daily, for 12 weeks
  • Placebo — DRUG
    Participants will receive ALKS 2680-matching placebo tablets, 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
Apr 6, 2026
Status verified
Jun 2026
Primary completion
May 31, 2027
Completion
Jun 30, 2027

Study Design

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

Arms

  • Placebo Comparator: Placebo
    Placebo arm
  • Experimental: ALKS 2680 Dose 1
    Oral tablet containing ALKS 2680
  • Experimental: ALKS 2680 Dose 2
    Oral tablet containing ALKS 2680

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 (15)

FacilityCityStateZIPSite coordinators
Alkermes Investigational SiteLos AngelesCalifornia90025-
Alkermes Investigational SiteBoulderColorado80301-
Alkermes Investigational SiteBrandonFlorida33511-
Alkermes Investigational SiteMiamiFlorida33176-
Alkermes Investigational SiteWinter ParkFlorida32789-
Alkermes Investigational SiteMaconGeorgia31210-
Alkermes Investigational SiteNewtonMassachusetts02459-
Alkermes Investigational SiteLansingMichigan48911-
Alkermes Investigational SiteSt LouisMissouri63123-
Alkermes Investigational SiteCincinnatiOhio45245-
Alkermes Investigational SiteWyomissingPennsylvania19610-
Alkermes Investigational SiteColumbiaSouth Carolina29201-
Alkermes Investigational SiteAustinTexas78731-
Alkermes Investigational SiteSan AntonioTexas78229-
Alkermes Investigational SiteSugar LandTexas77478-

Find similar trials in Los Angeles, CA

By research site
Alkermes Investigational Site· Los Angeles, CAAlkermes Investigational Site· Boulder, COAlkermes Investigational Site· Brandon, FLAlkermes Investigational Site· Miami, FLAlkermes Investigational Site· Winter Park, FLAlkermes Investigational Site· Macon, GA

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