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

Phase 2

Recruiting

• Conditions: Narcolepsy Type 1; Narcolepsy Type 2; Idiopathic Hypersomnia
• Interventions: Drug: ALKS 2680, 4mg; Drug: ALKS 2680, 10mg; Drug: ALKS 2680, 6mg; Drug: ALKS 2680, 14mg; Drug: ALKS 2680, 8mg; Drug: ALKS 2680, 18mg

• Registration Number: NCT06767683
• Lead Sponsor: Alkermes, Inc.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-06
• Study First Submitted QC: 2025-01-06
• Study First Posted: 2025-01-10
• Study Start: 2025-01-27
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-22
• Primary Completion: 2027-11
• Study Completion: 2027-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 256

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Narcolepsy Type 1 (NT1)	ALKS 2680, 4mg	-
Narcolepsy Type 1 (NT1)	ALKS 2680, 6mg	-
Idiopathic Hypersomnia (IH)	ALKS 2680, 14mg	-
Narcolepsy Type 1 (NT1)	ALKS 2680, 8mg	-
Narcolepsy Type 2 (NT2)	ALKS 2680, 10mg	-
Narcolepsy Type 2 (NT2)	ALKS 2680, 14mg	-
Narcolepsy Type 2 (NT2)	ALKS 2680, 18mg	-
Idiopathic Hypersomnia (IH)	ALKS 2680, 10mg	-
Idiopathic Hypersomnia (IH)	ALKS 2680, 18mg	-

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events	Up to 100 Weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Alkermes Investigational Site; 🇪🇸 Madrid, Spain