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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo 		Placebo arm
  • Drug: Placebo
    Participants will receive ALKS 2680-matching placebo tablets, orally, for 12 weeks.
Experimental
ALKS 2680 Dose 1 		Oral tablet containing ALKS 2680
  • Drug: ALKS 2680 Dose 1
    Participants will receive ALKS 2680 tablets, orally, daily, for 12 weeks
    Other names:
    • Alixorexton
Experimental
ALKS 2680 Dose 2 		Oral tablet containing ALKS 2680
  • Drug: ALKS 2680 Dose 2
    Participants will receive ALKS 2680 tablets, orally, daily, for 12 weeks
    Other names:
    • Alixorexton

Recruiting Locations

Alkermes Investigational Site
Cincinnati, Ohio 45245

Alkermes Investigational Site
Austin, Texas 78731

Alkermes Investigational Site
Sugar Land, Texas 77478

More Details

Status
Recruiting
Sponsor
Alkermes, Inc.

Study Contact

Director, Clinical Trial Manager
888-235-8008 (US Only)
clinicaltrials@alkermes.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.