A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2

Purpose

The purpose of this study is to measure decreases in daytime sleepiness, and disease symptoms in participants with Narcolepsy Type 2 (NT2) when taking ALKS 2680 tablets compared with placebo tablets.

Condition

  • Narcolepsy Type 2

Eligibility

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

Inclusion Criteria

  • Is willing and able, in the opinion of the Investigator, to understand and comply with protocol requirements, including the following: lifestyle considerations and restrictions, adherence to contraception guidance, adherence to actigraphy and diary requirements, if receiving treatment for OSA, adherence to primary OSA therapy over the 30 days prior to Visit 1, and throughout the study, including during overnight visits. - Meets the diagnostic criteria of NT2 according to ICSD-3-TR guidelines, confirmed by diagnostic evaluations (either PSG/MSLT).

Exclusion Criteria

  • Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle. - Has a history or presence 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 2680-202 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
Experimental
ALKS 2680 Dose 1
  • Drug: ALKS 2680 Dose 1
    Participants will receive ALKS 2680 tablets, daily, orally, for 12 weeks
    Other names:
    • Alixorexton
Experimental
ALKS 2680 Dose 2
  • Drug: ALKS 2680 Dose 2
    Participants will receive ALKS 2680 tablets, daily, orally, for 12 weeks
    Other names:
    • Alixorexton
Experimental
ALKS 2680 Dose 3
  • Drug: ALKS 2680 Dose 3
    Participants will receive ALKS 2680 tablets, daily, orally, for 12 weeks
    Other names:
    • Alixorexton
Placebo Comparator
Placebo
  • Drug: Placebo
    Participants will receive placebo tablets, daily, orally for 12 weeks

Recruiting Locations

Alkermes Investigational Site
Cincinnati, Ohio 45245

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