A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2

A Phase 2, Parallel-Group, Dose-Range-Finding Study With Randomized Double-Blind Treatment and Open-Label Periods to Evaluate the Safety and Efficacy of ALKS 2680 in Subjects With Narcolepsy Type 2

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06555783

Acronym

Vibrance-2

Enrollment

Registered

2024-08-15

Start date

2024-07-26

Completion date

2025-11-21

Last updated

2026-02-27

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

Conditions

Narcolepsy Type 2

Keywords

Narcolepsy, Narcolepsy Type 2, NT2, Orexin-2 receptor agonist, Sleep, Sleep disorder, Excessive daytime sleepiness

Brief summary

The purpose of this study is to measure the safety and decrease in sleepiness in subjects with narcolepsy type 2 (NT2) when taking ALKS 2680 tablets compared to placebo tablets.

Interventions

DRUGALKS 2680

Oral tablet containing ALKS 2680

DRUGPlacebo

Oral tablet containing placebo for once daily administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* 18-70 years of age * Has a BMI ≥18 and ≤40 kg/m2 * Meets the diagnostic criteria of Narcolepsy type 2 according to ICSD-3-TR guidelines. Additionally, meets the following criteria: * Has residual excessive daytime sleepiness * Is willing and able to discontinue any medications prescribed for the management of narcolepsy symptoms for at least 14 days and for the duration of study * Is willing to adhere to additional protocol requirements

Exclusion criteria

* Significant comorbid medical conditions, including other sleep, cardiovascular, psychiatric, hepatic or other disorders may be exclusionary; eligibility will be determined on an individual basis by the study investigator * 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	Description
Change in Mean Sleep Latency (MSL) on the Maintenance Wakefulness Test (MWT)	Baseline to Week 8	—
Change in Epworth Sleepiness Scale (ESS)	Baseline to week 8	Participants will be asked to complete the ESS, reporting on the level of sleepiness they experienced over the past 7 days.

Secondary

Measure	Time frame
Incidence of adverse events	Up to 21 weeks

Countries

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

Contacts

STUDY_DIRECTORMedical Director, MD

Alkermes, Inc.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026