A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia
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
Alkermes, Inc.
256 participants
Jan 27, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria2
- 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 Criteria3
- 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
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Interventions
Oral tablet containing 4 mg of ALKS 2680 for once daily administration
Oral tablet containing 6 mg of ALKS 2680 for once daily administration
Oral tablet containing 8 mg of ALKS 2680 for once daily administration
Oral tablet containing 10 mg of ALKS 2680 for once daily administration
Oral tablet containing 14 mg of ALKS 2680 for once daily administration
Oral tablet containing 18 mg of ALKS 2680 for once daily administration
Locations(46)
View Full Details on ClinicalTrials.gov
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NCT06767683