A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (ALKS 2680-201)

Part of paid clinical trials in Los Angeles, California.

Sponsor
Alkermes, Inc.
Study ID
NCT06358950
Phase
PHASE2
Status
Completed

Conditions

  • Narcolepsy Type 1

Eligibility Criteria

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

Interventions

  • ALKS 2680 — DRUG
    Oral tablet of ALKS 2680 for once daily administration
  • Placebo — DRUG
    Oral tablet containing matching placebo for once daily administration

Study Details

The purpose of this research study is to assess the safety and efficacy of ALKS 2680 compared to placebo, including whether participants taking ALKS 2680 experience a greater decrease in sleepiness and a decrease in cataplexy ("sudden loss of muscle control"), compared to participants taking placebo alone.

Key Dates

Start date
Mar 24, 2024
Status verified
Jun 2026
Primary completion
Jun 19, 2025
Completion
Jul 31, 2025

Study Design

Enrollment
92 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 4 mg ALKS 2680
  • Experimental: 6 mg ALKS 2680
  • Experimental: 8 mg ALKS 2680
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change in Mean Sleep Latency (MSL) on the Maintenance of Wakefulness Test (MWT) from baseline to Week 6 [ Time Frame: Baseline to Week 6 ]

Locations (29)

FacilityCityStateZIPSite coordinators
Alkermes Investigational SiteLos AngelesCalifornia90025-
Alkermes Investigational SiteRedwood CityCalifornia94063-
Alkermes Investigator SiteSan FranciscoCalifornia94107-
Alkermes Investigational SiteSanta AnaCalifornia92705-
Alkermes Investigational SiteAuroraColorado80045-
Alkermes Investigational SiteColorado SpringsColorado80918-
Alkermes Investigational SiteBrandonFlorida33511-
Alkermes Investigator SiteBrandonFlorida33511-
Alkermes Investigational SiteMiamiFlorida33176-
Alkermes Investigator SiteWinter ParkFlorida32789-
Alkermes Investigational SiteAtlantaGeorgia30328-
Alkermes Investigational SiteMaconGeorgia31210-
Alkermes Investigational SiteStockbridgeGeorgia30281-
Alkermes Investigator SitePeoriaIllinois61637-
Alkermes Investigator SiteLansingMichigan48911-
Alkermes Investigator SiteSterling HeightsMichigan48314-
Alkermes Investigator SiteLincolnNebraska68506-
Alkermes Investigational SiteMiddletownNew Jersey07748-
Alkermes Investigational SiteDenverNorth Carolina28037-
Alkermes Investigational SiteHuntersvilleNorth Carolina28708-
Alkermes Investigator SiteCantonOhio44718-
Alkermes Investigational SiteCincinnatiOhio45227-
Alkermes Investigational SiteCincinnatiOhio45245-
Alkermes Investigational SiteDublinOhio43017-
Alkermes Investigational SiteWyomissingPennsylvania19610-
Alkermes Investigational SiteColumbiaSouth Carolina29201-
Alkermes Investigational SiteAustinTexas78731-
Alkermes Investigational SiteSan AntonioTexas78229-
Alkermes Investigational SiteThe WoodlandsTexas77380-

Find similar trials in Los Angeles, CA

By research site
Alkermes Investigational Site· Los Angeles, CAAlkermes Investigational Site· Redwood City, CAAlkermes Investigator Site· San Francisco, CAAlkermes Investigational Site· Santa Ana, CAAlkermes Investigational Site· Aurora, COAlkermes Investigational Site· Colorado Springs, CO

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