Changeflow GovPing Healthcare & Life Sciences Phase 3 ALKS 2680 Narcolepsy Type 1 Study (NCT0...
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Phase 3 ALKS 2680 Narcolepsy Type 1 Study (NCT07540897)

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Summary

A Phase 3 clinical trial for ALKS 2680 (NCT07540897) in Narcolepsy Type 1 has been registered on ClinicalTrials.gov. The Brilliance NT1-304 study will evaluate efficacy, safety, and tolerability of two dose levels versus placebo in adults, measuring decreases in daytime sleepiness and cataplexy. This is an informational study listing and creates no compliance obligations.

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What changed

A Phase 3 clinical trial (NCT07540897) for ALKS 2680, an investigational treatment for Narcolepsy Type 1, has been registered on ClinicalTrials.gov. The Brilliance NT1-304 study is enrolling adults and will compare two active dose levels against placebo, with co-primary endpoints of daytime sleepiness and cataplexy reduction. This is an informational study listing; it does not impose any regulatory obligations or compliance requirements on sponsors, investigators, or healthcare providers.

For pharmaceutical sponsors and clinical investigators, this registration signals active Phase 3 development of ALKS 2680 for NT1 and may inform competitive landscape awareness, clinical trial feasibility assessments, and patient referral pathways. No filing, reporting, or compliance action is required in response to this notice.

Archived snapshot

Apr 21, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

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

Phase 3 NCT07540897 Kind: PHASE3 Apr 21, 2026

Abstract

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.

Conditions: Narcolepsy Type 1

Interventions: ALKS 2680 Dose 1, ALKS 2680 Dose 2, Placebo

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Last updated

Classification

Agency
NIH
Published
April 21st, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07540897

Who this affects

Applies to
Pharmaceutical companies Clinical investigators Healthcare providers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Clinical trial registration Drug development Narcolepsy treatment study
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Clinical Operations
Topics
Healthcare

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