Health Trials

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • ALKS 2680, 4mg
  • ALKS 2680, 6mg
  • ALKS 2680, 8mg
  • ALKS 2680, 10mg
  • ALKS 2680, 14mg
  • ALKS 2680, 18mg

Treatment groups

256 Participants
are divided into 3 treatment groups

Locations

46
Australia
Alkermes Investigational Site2113, SydneyNew South Wales, Australia
Alkermes Investigational Site5042, Bedford ParkSouth Australia, Australia
Alkermes Investigational Site3168, ClaytonVictoria, Australia
Belgium
Alkermes Investigational Site8000, BrugesBrugge, Belgium

Sponsors and collaborators

Alkermes, Inc.

Lead sponsor

Source ClinicalTrials.gov