A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Alkermes, Inc.
Study ID
NCT06767683
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Idiopathic Hypersomnia
  • Narcolepsy Type 1
  • Narcolepsy Type 2

Eligibility Criteria

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

Interventions

  • ALKS 2680, 4mg — DRUG
    Oral tablet containing 4 mg of ALKS 2680 for once daily administration
  • ALKS 2680, 6mg — DRUG
    Oral tablet containing 6 mg of ALKS 2680 for once daily administration
  • ALKS 2680, 8mg — DRUG
    Oral tablet containing 8 mg of ALKS 2680 for once daily administration
  • ALKS 2680, 10mg — DRUG
    Oral tablet containing 10 mg of ALKS 2680 for once daily administration
  • ALKS 2680, 14mg — DRUG
    Oral tablet containing 14 mg of ALKS 2680 for once daily administration
  • ALKS 2680, 18mg — DRUG
    Oral tablet containing 18 mg of ALKS 2680 for once daily administration

Study Details

The purpose of this study is to continue to measure the safety, tolerability, and durability of treatment effect in subjects with Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), or Idiopathic Hypersomnia (IH) when taking ALKS 2680 tablets.

Key Dates

Start date
Jan 27, 2025
Status verified
Mar 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
256 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Narcolepsy Type 1 (NT1)
  • Experimental: Narcolepsy Type 2 (NT2)
  • Experimental: Idiopathic Hypersomnia (IH)

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events [ Time Frame: Up to 100 Weeks ]

Central Contacts

Locations (30)

FacilityCityStateZIPSite coordinators
Alkermes Investigator SitePhoenixArizona85054-
Alkermes Investigational SiteLittle RockArkansas72211-
Alkermes Investigational SiteLos AngelesCalifornia90025-
Alkermes Investigator SiteSan FranciscoCalifornia94158-
Alkermes Investigational SiteStanfordCalifornia94305-
Alkermes Investigational SiteColorado SpringsColorado80918-
Alkermes Investigational SiteBrandonFlorida33511-
Alkermes Investigational SiteMiamiFlorida33176-
Alkermes Investigational SiteWinter ParkFlorida32789-
Alkermes Investigational SiteAtlantaGeorgia30328-
Alkermes Investigational SiteMaconGeorgia31210-
Alkermes Investigational SiteStockbridgeGeorgia30281-
Alkermes Investigational SitePeoriaIllinois61637-
Alkermes Investigational SiteLansingMichigan48911-
Alkermes Investigational SiteSterling HeightsMichigan48314-
Alkermes Investigational SiteLincolnNebraska68506-
Alkermes Investigational SiteMiddletownNew Jersey07748-
Alkermes Investigational SiteDenverNorth Carolina28037-
Alkermes Investigational SiteHuntersvilleNorth Carolina28708-
Alkermes Investigational SiteCantonOhio44718-
Alkermes Investigational SiteCincinnatiOhio45212-
Alkermes Investigational SiteCincinnatiOhio45245-
Alkermes Investigational SiteDublinOhio43017-
Alkermes Investigational SiteAbingtonPennsylvania19001-
Alkermes Investigational SiteWyomissingPennsylvania19610-
Alkermes Investigational SiteColumbiaSouth Carolina29201-
Alkermes Investigational SiteAustinTexas78731-
Alkermes Investigational SiteSan AntonioTexas78229-
Alkermes Investigational SiteSugar LandTexas77478-
Alkermes Investigational SiteMadisonWisconsin53706-

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Alkermes Investigator Site· Phoenix, AZAlkermes Investigational Site· Little Rock, ARAlkermes Investigational Site· Los Angeles, CAAlkermes Investigator Site· San Francisco, CAAlkermes Investigational Site· Stanford, CAAlkermes Investigational Site· Colorado Springs, CO

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