NCT07540897

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
14mo left

Started May 2026

Shorter than P25 for phase_3

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
May 2026Jul 2027

First Submitted

Initial submission to the registry

April 15, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 21, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

1.1 years

First QC Date

April 15, 2026

Last Update Submit

April 15, 2026

Conditions

Narcolepsy Type 1

Keywords

Narcolepsy Type 1NT1AlixorextonSleepinessOrexin-2Orexin-2 receptor agonistsleep disorderexcessive daytime sleepiness

Outcome Measures

Primary Outcomes (1)

  • Change in mean sleep latency (MSL) on Maintenance of Wakefulness Test (MWT) from baseline to Week 12 by dose level

    Baseline to Week 12

Secondary Outcomes (9)

  • Change in Epworth Sleepiness Scale (ESS) from baseline to Week 12 by dose level

    Baseline to Week 12

  • Weekly cataplexy rate (WCR) at Week 12 by dose level

    Week 12

  • Percentage of participants who achieve a status of "none" or "mild" on Patient Global Impression- Severity (PGI-S) scale(general disease) at Week 12 by dose level

    Week 12

  • Change in British Columbia Cognitive Complaints Inventory (BC-CCI) from baseline to Week 12 by dose level

    Baseline to Week 12

  • Change in number of lapses on Psychomotor Vigilance Task (PVT) from baseline to Week 12 by dose level

    Baseline to Week 12

  • +4 more secondary outcomes

Study Arms (3)

ALKS 2680 Dose 1

EXPERIMENTAL
Drug: ALKS 2680 Dose 1

ALKS 2680 Dose 2

EXPERIMENTAL
Drug: ALKS 2680 Dose 2

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

ALKS 2680 Dose 1DRUG

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

Also known as: Alixorexton
ALKS 2680 Dose 1
ALKS 2680 Dose 2DRUG

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

Also known as: Alixorexton
ALKS 2680 Dose 2
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

SleepinessSleep Wake DisordersDisorders of Excessive Somnolence

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsNervous System DiseasesNeurologic ManifestationsMental DisordersSleep Disorders, IntrinsicDyssomnias

Study Officials

  • Medical Director, MD

    Alkermes, Inc.

    STUDY DIRECTOR

Central Study Contacts

Director, Clinical Trial Manager

CONTACT

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

Director, Clinical Trial Manager

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2026

First Posted

April 21, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

April 21, 2026

Record last verified: 2026-04