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Recruiting Phase 2/3 NCT06767683

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

Phase 2/3 – combined trial
Conditions: Narcolepsy Type 1 Narcolepsy Type 2 Idiopathic Hypersomnia

Sponsor: Alkermes, Inc.

trial.available_in: БГ
Overview
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.
Who can participate
Inclusion Criteria: * 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) * 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) Exclusion Criteria: * 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 8
Australia (1)
Alkermes Investigational Site
Sydney , New South Wales
Belgium (1)
Alkermes Investigational Site
Bruges , Brugge
Czech Republic (1)
Alkermes Investigational Site
Prague
France (1)
Alkermes Investigational Site
Montpellier , Herault
Italy (1)
Alkermes Investigational Site
Bologna
Netherlands (1)
Alkermes Investigational Site
Zwolle
Spain (1)
Alkermes Investigational Site
Madrid , Madrid
United States (1)
Alkermes Investigator Site
Phoenix , Arizona
Technical details
Status
Recruiting
Phase
Phase 2/3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
70 Years
Healthy volunteers
No
Start date
27.01.2025
Completion date
01.06.2028
Registry ID
NCT06767683
Source
anzctr
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