Clinical trial NCT06767683: A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia
Official title: An Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Durability of Treatment Effect of ALKS 2680 in Subjects With Narcolepsy Type 1 and Type 2 and Idiopathic Hypersomnia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Narcolepsy Type 1
Narcolepsy Type 2
Idiopathic Hypersomnia
Keywords: Narcolepsy
Narcolepsy Type 1
Narcolepsy Type 2
NT1
NT2
orexin-2 receptor agonist
sleep
sleep disorder
excessive daytime sleepiness
IH
Idiopathic Hypersomnia
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2025-01-10
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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) or Narcolepsy Type 2 (NT2) when taking ALKS 2680 tablets


Eligibility criteria: Inclusion Criteria:

* Was eligible for and has completed end of treatment visit of ALKS 2680 eligible parent study in NT1, NT2 or IH. The current eligible studies are ALKS 2680-201 (Vibrance-1), ALKS 2680-202 (Vibrance-2) and ALKS 2680-203 (Vibrance-3)
* Is willing and able, and in the opinion of the treating physician can safely discontinue any medications prescribed for the management of narcolepsy symptoms, as applicable, for 5 half-lives prior to Day 1 (for re-entry subjects), and for the duration of study (for all subjects)

Exclusion Criteria:

* Developed a new clinically significant health condition, ECG or laboratory abnormality, in the opinion of the Investigator or Sponsor, may impact the subject's participation in the study
* Is currently pregnant, breastfeeding, or planning to become pregnant during the study
* Is currently enrolled in another clinical study (other than the parent study) or used any investigational drug or device within 30 days prior to Screening

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Up to 100 Weeks
Secondary outcomes:
measure: Change in the mean sleep latency (MSL) on Maintenance of Wakefulness Test (MWT)
timeFrame: Baseline to Week 24
measure: Change in Epworth Sleepiness Scale (ESS)
timeFrame: Baseline to 96 Weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Alkermes Investigational Site
state: Arkansas
city: Los Angeles
country: United States
facility: Alkermes Investigational Site
state: California
city: Stanford
country: United States
facility: Alkermes Investigational Site
state: California
city: Colorado Springs
country: United States
facility: Alkermes Investigational Site
state: Colorado
city: Brandon
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Miami
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Winter Park
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Macon
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Stockbridge
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Lansing
country: United States
facility: Alkermes Investigational Site
state: Michigan
city: Sterling Heights
country: United States
facility: Alkermes Investigational Site
state: Michigan
city: Lincoln
country: United States
facility: Alkermes Investigational Site
state: Nebraska
city: Middletown
country: United States
facility: Alkermes Investigational Site
state: New Jersey
city: Denver
country: United States
facility: Alkermes Investigational Site
state: North Carolina
city: Huntersville
country: United States
facility: Alkermes Investigational Site
state: North Carolina
city: Canton
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Dublin
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Abington
country: United States
facility: Alkermes Investigational Site
state: Pennsylvania
city: Wyomissing
country: United States
facility: Alkermes Investigational Site
state: Pennsylvania
city: Columbia
country: United States
facility: Alkermes Investigational Site
state: South Carolina
city: Austin
country: United States
facility: Alkermes Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Sydney
country: Australia
facility: Alkermes Investigational Site
state: New South Wales
city: Madrid
country: Spain
facility: Alkermes Investigational Site
Study officials:
affiliation: Alkermes, Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: