A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia

Part of paid clinical trials in Cullman, Alabama.

Sponsor
Alkermes, Inc.
Study ID
NCT06843590
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Idiopathic Hypersomnia

Eligibility Criteria

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

Interventions

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

Study Details

The purpose of this study is to measure the safety and decrease in daytime sleepiness in subjects with Idiopathic Hypersomnia when taking ALKS 2680 tablets compared with placebo tablets

Key Dates

First listed
Feb 25, 2025
Start date
May 22, 2025
Status verified
Jun 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

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

Arms

  • Experimental: ALKS 2680, 10 mg- Part A
    Oral tablet containing 10 mg of ALKS 2680 for once daily administration
  • Experimental: ALKS 2680, 14 mg -Part A
    Oral tablet containing 14 mg of ALKS 2680 for once daily administration
  • Experimental: ALKS 2680, 18 mg- Part A
    Oral tablet containing 18 mg of ALKS 2680 for once daily administration
  • Placebo Comparator: Placebo- Part A
    Oral placebo tablet for once daily administration
  • Experimental: ALKS 2680 Dose 1- Part B
    Oral tablets of ALKS 2680 taken, orally, daily
  • Placebo Comparator: Placebo - Part B
    Oral tablets of placebo taken, orally, daily

Primary Outcome Measure

Change in Epworth Sleepiness Scale (ESS) from baseline to Week 8 by dose level [ Time Frame: Up to 8 weeks ]

Central Contacts

Locations (34)

FacilityCityStateZIPSite coordinators
Alkermes Investigator SiteCullmanAlabama35055-
Alkermes Investigator SitePhoenixArizona85054-
Alkermes Investigator SiteLittle RockArkansas72211-
Alkermes Investigator SiteLos AngelesCalifornia90025-
Alkermes Investigator SiteRedwood CityCalifornia94063-
Alkermes Investigator SiteSan FranciscoCalifornia94143-
Alkermes Investigational SiteBoulderColorado80301-
Alkermes Investigator SiteColorado SpringsColorado80918-
Alkermes Investigator SiteBrandonFlorida33511-
Alkermes Investigator SiteMiamiFlorida33176-
Alkermes Investigator SiteWinter ParkFlorida32789-
Alkermes Investigator SiteAtlantaGeorgia30328-
Alkermes Investigator SiteMaconGeorgia31210-
Alkermes Investigator SiteStockbridgeGeorgia30281-
Alkermes Investigator SitePeoriaIllinois61637-
Alkermes Investigator SiteKansas CityKansas66160-
Alkermes Investigational SiteBostonMassachusetts02215-
Alkermes Investigator SiteLansingMichigan48911-
Alkermes Investigator SiteLincolnNebraska68506-
Alkermes Investigator SiteMiddletownNew Jersey07748-
Alkermes Investigator SiteDenverNorth Carolina28037-
Alkermes Investigator SiteHuntersvilleNorth Carolina28078-
Alkermes Investigator SiteCantonOhio44718-
Alkermes Investigator SiteCincinnatiOhio45245-
Alkermes Investigator SiteClevelandOhio44195-
Alkermes Investigator SiteDanvillePennsylvania17822-
Alkermes Investigator SitePhiladelphiaPennsylvania19107-
Alkermes Investigator SiteWyomissingPennsylvania19610-
Alkermes Investigator SiteColumbiaSouth Carolina29201-
Alkermes Investigator SiteAustinTexas78731-
Alkermes Investigator SiteSan AntonioTexas78229-
Alkermes Investigator SiteSugar LandTexas77478-
Alkermes Investigator SiteSugarlandTexas77478-
Alkermes Investigator SiteMadisonWisconsin53792-

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Alkermes Investigator Site· Cullman, ALAlkermes Investigator Site· Phoenix, AZAlkermes Investigator Site· Little Rock, ARAlkermes Investigator Site· Los Angeles, CAAlkermes Investigator Site· Redwood City, CAAlkermes Investigator Site· San Francisco, CA

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