A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2

a study on Narcolepsy

Summary

Eligibility
for people ages 18-70 (full criteria)
Location
at UCSF
Dates
study started
study ends around

Description

Summary

The purpose of this study is to measure the safety and decrease in sleepiness in subjects with narcolepsy type 2 (NT2) when taking ALKS 2680 tablets compared to placebo tablets.

Official Title

A Phase 2, Parallel-Group, Dose-Range-Finding Study With Randomized Double-Blind Treatment and Open-Label Periods to Evaluate the Safety and Efficacy of ALKS 2680 in Subjects With Narcolepsy Type 2

Keywords

Narcolepsy Type 2, Narcolepsy, NT2, Orexin-2 receptor agonist, Sleep, Sleep disorder, Excessive daytime sleepiness, Sleep Wake Disorders, Disorders of Excessive Somnolence, Counterfeit Drugs, ALKS 2680, ALKS 2680, 10 mg, ALKS 2680, 14 mg, ALKS 2680, 18 mg

Eligibility

You can join if…

Open to people ages 18-70

  • 18-70 years of age
  • Has a BMI ≥18 and ≤40 kg/m2
  • Meets the diagnostic criteria of Narcolepsy type 2 according to ICSD-3-TR guidelines.

Additionally, meets the following criteria:

  • Has residual excessive daytime sleepiness
  • Is willing and able to discontinue any medications prescribed for the management of narcolepsy symptoms for at least 14 days and for the duration of study
  • Is willing to adhere to additional protocol requirements

You CAN'T join if...

  • Significant comorbid medical conditions, including other sleep, cardiovascular, psychiatric, hepatic or other disorders may be exclusionary; eligibility will be determined on an individual basis by the study investigator
  • Is currently pregnant, breastfeeding, or planning to become pregnant during the study
  • Is currently enrolled in another clinical study (other than the parent study) or used any investigational drug or device within 30 days prior to Screening

Locations

  • Alkermes Investigator Site accepting new patients
    San Francisco 5391959 California 5332921 94143 United States
  • Alkermes Investigator Site accepting new patients
    Los Angeles 5368361 California 5332921 90025 United States
  • Alkermes Investigator Site accepting new patients
    Santa Ana 5392900 California 5332921 92705 United States
  • Alkermes Investigator Site accepting new patients
    Redwood City 5386834 California 5332921 94063 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Alkermes, Inc.
Links
Vibrance-2 Study
ID
NCT06555783
Phase
Phase 2 Narcolepsy Research Study
Study Type
Interventional
Participants
Expecting 80 study participants
Last Updated