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Bored Studies
RecruitingPhase 2/Phase 3

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

Alkermes, Inc. · NCT06767683

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–70 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2, Phase 3
Target enrollment
786
US sites recruiting
34
Study start
January 27, 2025
Record last updated
October 9, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: ALKS 2680, 4mg; ALKS 2680, 6mg; ALKS 2680, 8mg; ALKS 2680, 10mg; ALKS 2680, 14mg; ALKS 2680, 18mg

Conditions: Narcolepsy Type 1; Narcolepsy Type 2; Idiopathic Hypersomnia

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

Study contacts (from the official record)

  • Director, Global Clinical Services · 888-235-8008 (US Only) · clinicaltrials@alkermes.com
  • Director, Global Clinical Services · 571-599-2702 (Global) · clinicaltrials@alkermes.com
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