A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia

a study on Narcolepsy Idiopathic Hypersomnia

Summary

Eligibility
for people ages 18-70 (full criteria)
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by Andrew Krystal (ucsf)
Headshot of Andrew Krystal
Andrew Krystal

Description

Summary

The purpose of this study is to continue to measure the safety, tolerability, and durability of treatment effect in subjects with Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), or Idiopathic Hypersomnia (IH) when taking ALKS 2680 tablets.

Official Title

An Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Durability of Treatment Effect of ALKS 2680 in Subjects With Narcolepsy Type 1 and Type 2 and Idiopathic Hypersomnia

Keywords

Narcolepsy Type 1, Narcolepsy Type 2, Idiopathic Hypersomnia, Narcolepsy, NT1, NT2, orexin-2 receptor agonist, sleep, sleep disorder, excessive daytime sleepiness, IH, Sleep Wake Disorders, Disorders of Excessive Somnolence, ALKS 2680, 4mg, ALKS 2680, 6mg, ALKS 2680, 8mg, ALKS 2680, 10mg, ALKS 2680, 14mg, ALKS 2680, 18mg, Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), Idiopathic Hypersomnia (IH)

Eligibility

You can join if…

Open to people ages 18-70

  • Was eligible for and has completed end of treatment visit of ALKS 2680 eligible parent study in NT1, NT2 or IH. The current eligible studies are ALKS 2680-201 (Vibrance-1), ALKS 2680-202 (Vibrance-2) and ALKS 2680-203 (Vibrance-3), ALKS 2680-302 (Brilliance NT1) , ALKS 2680-303 (Brilliance NT2) , ALKS 2680-304 (Brilliance NT 1)
  • Is willing and able, and in the opinion of the treating physician can safely discontinue any medications prescribed for the management of narcolepsy symptoms, as applicable, for 5 half-lives prior to Day 1 (for re-entry subjects), and for the duration of study (for all subjects)

You CAN'T join if...

  • Developed a new clinically significant health condition, ECG or laboratory abnormality, in the opinion of the Investigator or Sponsor, may impact the subject's participation in the study
  • 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 Investigational Site accepting new patients
    Los Angeles California 90025 United States
  • Alkermes Investigator Site accepting new patients
    San Francisco California 94158 United States
  • Alkermes Investigational Site accepting new patients
    Stanford California 94305 United States

Lead Scientist at University of California Health

  • Andrew Krystal (ucsf)
    Dr. Krystal is the Ray and Dagmar Dolby Distinguished Professor in the Departments of Psychiatry and Neurology, Vice-Chair for Research in the Department of Psychiatry, Director of the Dolby Family Center for Mood Disorders, Director of the UCSF Interventional Psychiatry Program and Director of the Clinical and Translational Sleep Research Laboratory.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Alkermes, Inc.
ID
NCT06767683
Phase
Phase 2/3 research study
Study Type
Interventional
Participants
Expecting 786 study participants
Last Updated
Contact us about this trial