Recruiting NCT06767683
A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ALKS 2680, 4mg, ALKS 2680, 6mg, ALKS 2680, 8mg, ALKS 2680, 10mg.
- Who it may be relevant to
- Registry conditions: Narcolepsy Type 1, Narcolepsy Type 2, Idiopathic Hypersomnia. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Belgium, Czechia, France +3
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
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.
Interventions
- Drug ALKS 2680, 4mg
Oral tablet containing 4 mg of ALKS 2680 for once daily administration - Drug ALKS 2680, 6mg
Oral tablet containing 6 mg of ALKS 2680 for once daily administration - Drug ALKS 2680, 8mg
Oral tablet containing 8 mg of ALKS 2680 for once daily administration - Drug ALKS 2680, 10mg
Oral tablet containing 10 mg of ALKS 2680 for once daily administration - Drug ALKS 2680, 14mg
Oral tablet containing 14 mg of ALKS 2680 for once daily administration - Drug ALKS 2680, 18mg
Oral tablet containing 18 mg of ALKS 2680 for once daily administration
Primary outcome measures
- Incidence of Treatment-Emergent Adverse Events [Time frame: Up to 100 Weeks]
Secondary outcome measures (2)
- Change in the mean sleep latency (MSL) on Maintenance of Wakefulness Test (MWT) [Time frame: Baseline to Week 24]
- Change in Epworth Sleepiness Scale (ESS) [Time frame: Baseline to 96 Weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 33 centers
- Alkermes Investigational Site — Cullman
- Alkermes Investigator Site — Phoenix
- Alkermes Investigational Site — Little Rock
- Alkermes Investigational Site — Los Angeles
- Alkermes Investigator Site — San Francisco
- Alkermes Investigational Site — Stanford
- Alkermes Investigational Site — Boulder
- Alkermes Investigational Site — Colorado Springs
- … and 25 more centers
Australia · 3 centers
- Alkermes Investigational Site — Sydney
- Alkermes Investigational Site — Bedford Park
- Alkermes Investigational Site — Clayton
Belgium · 3 centers
- Alkermes Investigational Site — Bruges
- Alkermes Investigational Site — Alken
- Alkermes Investigational Site — Namur
Italy · 3 centers
- Alkermes Investigational Site — Bologna
- Alkermes Investigational Site — Milan
- Alkermes Investigational Site — Verona
Spain · 3 centers
- Alkermes Investigational Site — Madrid
- Alkermes Investigational Site — Barcelona
- Alkermes Investigational Site — Madrid
France · 2 centers
- Alkermes Investigational Site — Montpellier
- Alkermes Investigational Site — Bordeaux
Czechia · 1 center
- Alkermes Investigational Site — Prague
Netherlands · 1 center
- Alkermes Investigational Site — Zwolle
Identifiers
NCT: NCT06767683 · ALKS 2680-301