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NCT07540897 · ClinicalTrials.gov registry record · Phase 3

A Study to Evaluate the Efficacy, Safety and Tolerability of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 304)

A Phase 3 study, sponsored by Alkermes.

Recruiting
Registry status
Phase 3
Development phase
150
Enrollment target

NCT07540897: Recruiting Phase 3 study, sponsored by Alkermes.

NCT07540897 is a Phase 3 study that is actively recruiting participants, run by Alkermes. The registered enrollment target is 150 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07540897, a Phase 3 study, is actively recruiting participants, sponsored by Alkermes.

RECRUITING
Registry status
Phase 3
Development phase
150 participants
Enrollment target

Study Summary

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.

Interventions

  • DRUG Placebo
  • DRUG ALKS 2680 Dose 1
  • DRUG ALKS 2680 Dose 2

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2026-06
Est. Completion 2027-07
Phase Phase 3
Alkermes

66 total trials

What NCT07540897 shows while recruiting

NCT07540897 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT07540897 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07540897 about?

NCT07540897 is a clinical study titled "A Study to Evaluate the Efficacy, Safety and Tolerability of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 304)". 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.

What is the current status of trial NCT07540897?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 150 participants. The study started on 2026-06. Estimated completion is 2027-07.

What interventions are being tested in trial NCT07540897?

The interventions under investigation include: Placebo (DRUG), ALKS 2680 Dose 1 (DRUG), ALKS 2680 Dose 2 (DRUG).

Who is sponsoring clinical trial NCT07540897?

This trial is sponsored by Alkermes, which has 66 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07540897's enrollment target sits among peer trials

150 1519th of 2000 higher than 455 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07540897, the US trial registry maintained by the National Library of Medicine. NCT07540897 (mid enrollment · none site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.