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

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

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06767683

Enrollment

256

Registered

2025-01-10

Start date

2025-01-27

Completion date

2028-06-01

Last updated

2026-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Hypersomnia, Narcolepsy Type 1, Narcolepsy Type 2

Keywords

Narcolepsy, Narcolepsy Type 1, Narcolepsy Type 2, NT1, NT2, orexin-2 receptor agonist, sleep, sleep disorder, excessive daytime sleepiness, IH, Idiopathic Hypersomnia

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

Interventions

DRUGALKS 2680, 4mg

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

DRUGALKS 2680, 6mg

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

DRUGALKS 2680, 8mg

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

DRUGALKS 2680, 10mg

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

DRUGALKS 2680, 14mg

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

DRUGALKS 2680, 18mg

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 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

Design outcomes

Primary

Measure	Time frame
Incidence of Treatment-Emergent Adverse Events	Up to 100 Weeks

Secondary

Measure	Time frame
Change in the mean sleep latency (MSL) on Maintenance of Wakefulness Test (MWT)	Baseline to Week 24
Change in Epworth Sleepiness Scale (ESS)	Baseline to 96 Weeks

Countries

Australia, Belgium, Czechia, France, Italy, Netherlands, Spain, United States

Contacts

CONTACTDirector, Global Clinical Services

clinicaltrials@alkermes.com888-235-8008 (US Only)

STUDY_DIRECTORMedical Director

Alkermes, Inc.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 8, 2026