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

NCT06767683 · tracked via the Priya Life Science USA tracker

Sponsor

Alkermes, Inc.

Phase

Phase 2/3

Started

2025-01-27

Last updated

2026-08-07

Condition(s) studied

Narcolepsy Type 1Narcolepsy Type 2Idiopathic Hypersomnia

Investigational drug(s) / intervention(s)

ALKS 2680, 4mgALKS 2680, 6mgALKS 2680, 8mgALKS 2680, 10mgALKS 2680, 14mgALKS 2680, 18mg

ALKS 2680, 4mg: Oral tablet containing 4 mg of ALKS 2680 for once daily administration

ALKS 2680, 6mg: Oral tablet containing 6 mg of ALKS 2680 for once daily administration

ALKS 2680, 8mg: Oral tablet containing 8 mg of ALKS 2680 for once daily administration

ALKS 2680, 10mg: Oral tablet containing 10 mg of ALKS 2680 for once daily administration

ALKS 2680, 14mg: Oral tablet containing 14 mg of ALKS 2680 for once daily administration

ALKS 2680, 18mg: Oral tablet containing 18 mg of ALKS 2680 for once daily administration

Study 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), Narcolepsy Type 2 (NT2), or Idiopathic Hypersomnia (IH) when taking ALKS 2680 tablets.

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

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 outcome measure(s)

Incidence of Treatment-Emergent Adverse Events — Up to 100 Weeks

Trial sites (49)

Facility	City	Region	Status
Alkermes Investigational Site	Cullman	Alabama	Recruiting
Alkermes Investigator Site	Phoenix	Arizona	Recruiting
Alkermes Investigational Site	Little Rock	Arkansas	Recruiting
Alkermes Investigational Site	Los Angeles	California	Recruiting
Alkermes Investigator Site	San Francisco	California	Recruiting
Alkermes Investigational Site	Stanford	California	Recruiting
Alkermes Investigational Site	Boulder	Colorado	Recruiting
Alkermes Investigational Site	Colorado Springs	Colorado	Recruiting
Alkermes Investigational Site	Brandon	Florida	Recruiting
Alkermes Investigational Site	Miami	Florida	Recruiting
Alkermes Investigational Site	Winter Park	Florida	Recruiting
Alkermes Investigational Site	Atlanta	Georgia	Recruiting
Alkermes Investigational Site	Macon	Georgia	Recruiting
Alkermes Investigational Site	Stockbridge	Georgia	Recruiting
Alkermes Investigational Site	Peoria	Illinois	Recruiting
Alkermes Investigational Site	Kansas City	Kansas	Recruiting
Alkermes Investigational Site	Lansing	Michigan	Recruiting
Alkermes Investigational Site	Sterling Heights	Michigan	Recruiting
Alkermes Investigational Site	Lincoln	Nebraska	Recruiting
Alkermes Investigational Site	Middletown	New Jersey	Recruiting
Alkermes Investigational Site	Denver	North Carolina	Recruiting
Alkermes Investigational Site	Huntersville	North Carolina	Recruiting
Alkermes Investigational Site	Canton	Ohio	Recruiting
Alkermes Investigational Site	Cincinnati	Ohio	Recruiting
Alkermes Investigational Site	Cincinnati	Ohio	Recruiting
Alkermes Investigational Site	Dublin	Ohio	Recruiting
Alkermes Investigational Site	Abington	Pennsylvania	Recruiting
Alkermes Investigational Site	Wyomissing	Pennsylvania	Recruiting
Alkermes Investigational Site	Columbia	South Carolina	Recruiting
Alkermes Investigational Site	Austin	Texas	Recruiting
Alkermes Investigational Site	San Antonio	Texas	Recruiting
Alkermes Investigational Site	Sugar Land	Texas	Recruiting
Alkermes Investigational Site	Madison	Wisconsin	Recruiting
Alkermes Investigational Site	Sydney	New South Wales	Recruiting
Alkermes Investigational Site	Bedford Park	South Australia	Recruiting
Alkermes Investigational Site	Clayton	Victoria	Recruiting
Alkermes Investigational Site	Bruges	Brugge	Recruiting
Alkermes Investigational Site	Alken	Belgium	Recruiting
Alkermes Investigational Site	Namur	Belgium	Recruiting
Alkermes Investigational Site	Prague	Czechia	Recruiting

+ 9 more sites — see the full list on the official registry below.

More Alkermes, Inc. trials in the USA

Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder Recruiting

A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2 Recruiting

A Study to Evaluate the Efficacy, Safety and Tolerability of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 304) Recruiting

A Study to Evaluate Safety and Efficacy of ALKS 7290 Compared With Placebo in Adult Participants With Attention Deficit Hyperactivity Disorder (ALKS 7290-201) Recruiting

A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1 Recruiting

Other trials for the same condition

A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions Recruiting

A Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia Recruiting

A Study of TAK-360 in Adults With Narcolepsy Type 1 (Narcolepsy With Cataplexy) Recruiting

A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2 Recruiting

A Study Evaluating the Efficacy and Safety of Xywav Expanded Dosing vs Placebo in Participants With Narcolepsy or IH Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06767683 on ClinicalTrials.gov ↗ ← All trials in the USA