A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Alkermes, Inc.
Study ID
NCT06555783
Phase
PHASE2
Status
Completed

Conditions

  • Narcolepsy Type 2

Eligibility Criteria

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

Interventions

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

Study Details

The purpose of this study is to measure the safety and decrease in sleepiness in subjects with narcolepsy type 2 (NT2) when taking ALKS 2680 tablets compared to placebo tablets.

Key Dates

Start date
Jul 26, 2024
Status verified
Feb 2026
Primary completion
Nov 11, 2025
Completion
Nov 21, 2025

Study Design

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

Arms

  • Experimental: ALKS 2680, 10 mg
    Oral tablet containing 10mg of ALKS 2680 for once daily administration
  • Experimental: ALKS 2680, 14 mg
    Oral tablet containing 14mg of ALKS 2680 for once daily administration
  • Experimental: ALKS 2680, 18 mg
    Oral tablet containing 18mg of ALKS 2680 for once daily administration
  • Placebo Comparator: Placebo
    Oral tablet containing matching placebo for once daily administration

Primary Outcome Measure

Change in Mean Sleep Latency (MSL) on the Maintenance Wakefulness Test (MWT) [ Time Frame: Baseline to Week 8 ]

Locations (33)

FacilityCityStateZIPSite coordinators
Alkermes Investigator SiteLittle RockArkansas72211-
Alkermes Investigator SiteLos AngelesCalifornia90025-
Alkermes Investigator SiteRedwood CityCalifornia94063-
Alkermes Investigator SiteSan FranciscoCalifornia94143-
Alkermes Investigator SiteSanta AnaCalifornia92705-
Alkermes Investigational SiteAuroraColorado80045-
Alkermes Investigator SiteColorado SpringsColorado80918-
Alkermes Investigator SiteBrandonFlorida33511-
Alkermes Investigator SiteMiamiFlorida33176-
Alkermes Investigator SiteWinter ParkFlorida32789-
Alkermes Investigator SiteAtlantaGeorgia30328-
Alkermes Investigational SiteMaconGeorgia31210-
Alkermes Investigator SiteStockbridgeGeorgia30281-
Alkermes Investigational SitePeoriaIllinois61637-
Alkermes Investigator SiteLansingMichigan48911-
Alkermes Investigator SiteSterling HeightsMichigan48314-
Alkermes Investigator SiteLincolnNebraska68506-
Alkermes Investigator SiteMiddletownNew Jersey07748-
Alkermes Investigator SiteDenverNorth Carolina28037-
Alkermes Investigator SiteHuntersvilleNorth Carolina28078-
Alkermes Investigator SiteCantonOhio44718-
Alkermes Investigator SiteCincinnatiOhio45212-
Alkermes Investigator SiteCincinnatiOhio45245-
Alkermes Investigational SiteClevelandOhio44195-
Alkermes Investigator SiteAbingtonPennsylvania19001-
Alkermes Investigational SitePhiladelphiaPennsylvania19107-
Alkermes Investigator SiteWyomissingPennsylvania19610-
Alkermes Investigator SiteColumbiaSouth Carolina29201-
Alkermes Investigator SiteCordovaTennessee38108-
Alkermes Investigator SiteAustinTexas78731-
Alkermes Investigator SiteSan AntonioTexas78229-
Alkermes Investigational SiteSugar LandTexas77478-
Alkermes Investigational SiteMadisonWisconsin53792-

Find similar trials in Little Rock, AR

By research site
Alkermes Investigator Site· Little Rock, ARAlkermes Investigator Site· Los Angeles, CAAlkermes Investigator Site· Redwood City, CAAlkermes Investigator Site· San Francisco, CAAlkermes Investigator Site· Santa Ana, CAAlkermes Investigational Site· Aurora, CO

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