Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in the USA / NCT06767683
Recruiting Phase 2/3

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
2026-10-09

Condition(s) studied

Narcolepsy Type 1Narcolepsy Type 2Idiopathic Hypersomnia

Investigational drug(s) / intervention(s)

ALKS 2680, 4mg →ALKS 2680, 6mg →ALKS 2680, 8mg →ALKS 2680, 10mg →ALKS 2680, 14mg →ALKS 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
No
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), ALKS 2680-302 (Brilliance NT1) , ALKS 2680-303 (Brilliance NT2) , ALKS 2680-304 (Brilliance NT 1) * 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 248 Weeks

Trial sites (50)

FacilityCityRegionStatus
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 Dallas 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

+ 10 more sites — see the full list on the official registry below.

More Alkermes, Inc. trials in the USA

Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects Enrolling by invitation
A Study to Evaluate the Safety and Efficacy of ALKS 7290 as an Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder 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 2 Recruiting

Other trials for the same condition

A Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence Recruiting
A Study of TAK-360 in Adults With Idiopathic Hypersomnia Recruiting
A Long-term Extension Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia Recruiting
A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions Recruiting
A Study to Evaluate the Efficacy, Safety and Tolerability of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 304) 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