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RecruitingPhase 3

A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1

Alkermes, Inc. · NCT07455383

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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 3
Target enrollment
150
US sites recruiting
22
Study start
April 6, 2026
Record last updated
October 7, 2026

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

What the study is about

The purpose of this study is to measure decreases in daytime sleepiness, cataplexy (sudden loss of muscle tone), and disease symptoms in participants with NT1 when taking ALKS 2680 tablets compared with placebo tablets.

Being studied: ALKS 2680 Dose 1; ALKS 2680 Dose 2; Placebo

Conditions: Narcolepsy Type 1

Eligibility criteria

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

Show full criteria

Inclusion Criteria

  • Meets the diagnostic criteria of NT1 according to ICSD-3-TR guidelines, confirmed by diagnostic evaluations (either PSG/MSLT* or CSF hypocretin-1 level).

Exclusion Criteria

  • Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle.
  • Has a history or presence at Visit 1 of other clinically significant (treated or untreated) illness, disease, abnormality, or surgical procedure that, in the opinion of the Investigator, might compromise participant safety, interfere with any study assessment, or affect the participant's ability to complete the study.
  • Is currently enrolled in another interventional clinical trial or has received any investigational drug or used any interventional investigational device within 30 days prior to Visit 1. Participants previously enrolled in Study ALKS 2680-201 are not eligible for enrollment.
  • Is currently pregnant, breastfeeding, or is planning to become pregnant during the study

Recruiting US locations

Study contacts (from the official record)

  • Director, Clinical Trial Manager · 888-235-8008 (US Only) · clinicaltrials@alkermes.com
  • Director, Clinical Trial Manager · 571-599-2702 (Global) · clinicaltrials@alkermes.com
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A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults… (NCT07455383) | Bored Studies