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

NCT06767683 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2026-03-04

No results posted yet for this 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.

Conditions

Interventions

DRUG

ALKS 2680, 4mg

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

DRUG

ALKS 2680, 6mg

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

DRUG

ALKS 2680, 8mg

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

DRUG

ALKS 2680, 10mg

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

DRUG

ALKS 2680, 14mg

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

DRUG

ALKS 2680, 18mg

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

Sponsors & Collaborators

  • Alkermes, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Alkermes, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-27
Primary Completion
2028-06-30
Completion
2028-06-30
FDA Drug
Yes

Countries

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

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06767683 on ClinicalTrials.gov