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

RecruitingPhase 3

Sponsor: Alkermes, Inc.

Conditions: Narcolepsy Type 2

Interventions: ALKS 2680 Dose 1, ALKS 2680 Dose 2, ALKS 2680 Dose 3, Placebo

Countries: United States, Belgium, Canada, France, Italy, Netherlands, Spain

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (28)

Cullman, Alabama, United States
Los Angeles, California, United States
Boulder, Colorado, United States
Brandon, Florida, United States
Maimi, Florida, United States
Winter Park, Florida, United States
Macon, Georgia, United States
Stockbridge, Georgia, United States
Kansas City, Kansas, United States
Newton, Massachusetts, United States
Lansing, Michigan, United States
Charlotte, North Carolina, United States
Huntersville, North Carolina, United States
Cincinnati, Ohio, United States
Wyomissing, Pennsylvania, United States
Columbia, South Carolina, United States
Austin, Texas, United States
San Antonio, Texas, United States
Sugar Land, Texas, United States
Namur, Belgium
Markham, Ontario, Canada
Toronto, Ontario, Canada
Bordeaux, France
Lyon, France
Montpellier, France
Bologna, Italy
Heeze, Netherlands
Barcelona, Spain