Recruiting

Phase 3

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

Sponsor:

Alkermes, Inc.

Code:

NCT07540897

Conditions

Narcolepsy Type 1

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

ALKS 2680 Dose 1

ALKS 2680 Dose 2

Placebo

Study Details

Brief 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.

Conditions

Narcolepsy Type 1

Study ID

NCT07540897

Start date

Aug 13, 2026

Status verified date

Oct, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ALKS 2680 Dose 1

experimental: ALKS 2680 Dose 2

placebo comparator: Placebo

Interventions

ALKS 2680 Dose 1

Participants will receive ALKS 2680 tablets, daily, orally, for 12 weeks

ALKS 2680 Dose 2

Participants will receive ALKS 2680 tablets, daily, orally, for 12 weeks

Placebo

Participants will receive placebo tablets, daily, orally for 12 weeks

Primary outcome measure

Change in mean sleep latency (MSL) on Maintenance of Wakefulness Test (MWT) from baseline to Week 12 by dose level [ Time Frame: Baseline to Week 12 ]

Central Contacts and Locations

Central contacts

Director, Clinical Trial Manager

888-235-8008 (US Only)clinicaltrials@alkermes.com

Director, Clinical Trial Manager

571-599-2702 (Global)clinicaltrials@alkermes.com

Locations

Alkermes Investigational Site

Recruiting

Brandon, Florida, United States, 33511

Alkermes Investigational Site

Recruiting

Miami, Florida, United States, 33176

Alkermes Investigational Site

Recruiting

Winter Park, Florida, United States, 32789

Alkermes Investigational Site

Recruiting

Atlanta, Georgia, United States, 30328

Alkermes Investigational Site

Recruiting

Macon, Georgia, United States, 31210

Alkermes Investigational Site

Recruiting

Lansing, Michigan, United States, 48911

Alkermes Investigational Site

Recruiting

St Louis, Missouri, United States, 63123

Alkermes Investigational Site

Recruiting

Charlotte, North Carolina, United States, 28210

Alkermes Investigational Site

Recruiting

Cincinnati, Ohio, United States, 45245

Alkermes Investigational Site

Recruiting

Colombia, South Carolina, United States, 29201

Alkermes Investigational Site

Recruiting

Dallas, Texas, United States, 75251

Alkermes Investigational Site

Recruiting

Frisco, Texas, United States, 75033

Alkermes Investigational Site

Recruiting

San Antonio, Texas, United States, 78229

Alkermes Investigational Site

Recruiting

Sugar Land, Texas, United States, 77478

Alkermes Investigational Site

Recruiting

Spokane, Washington, United States, 99202

Alkermes Investigational Site

Recruiting

Markham, Ontario, Canada, L3R 1A3

Alkermes Investigational Site

Recruiting

Toronto, Ontario, Canada, M5S 3A3

More Information

Sponsor

Alkermes, Inc.

Last update posted

Oct 7, 2026

Last verified

Oct, 2026

Keywords

Narcolepsy Type 1
NT1
Alixorexton
Sleepiness
Orexin-2
Orexin-2 receptor agonist
sleep disorder
excessive daytime sleepiness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Alkermes, Inc. on 2026-10-07. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.