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Taking people in ItalyPhase 3

A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1

Key facts

Who runs it
Alkermes, Inc.
Where
Verona, ItalySee the siteAlso in 9 other countries, 43 sites
Trial code
Status
Recruiting
Phase
Phase 3
People taking part
150 people, planned
Started
6 Apr 2026
Expected to end
Jun 2027
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • ALKS 2680 Dose 1
  • ALKS 2680 Dose 2
  • Placebo
Record updated
7 October 2026

Who can take part

Age
18 years to 70 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 5 criteriaShow less

Who can take part

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

Who cannot take part

  • 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
  • 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 pregnant, breastfeeding, or is planning to become pregnant during the study

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 70 years old?

Where in Italy

Also in 9 other countries, 43 sites

  • VeronaHospital not named in the registryContact: Director, Clinical Trial ManagerTaking people

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • PlaceboPlacebo, for comparison

    Placebo arm

  • ALKS 2680 Dose 1Treatment being tested

    Oral tablet containing ALKS 2680

  • ALKS 2680 Dose 2Treatment being tested

    Oral tablet containing ALKS 2680

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 Study 302)
Fit questions
Built from NCT07455383, who can take part
Record updated
7 October 2026