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.
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
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
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 h…
Interventions
- DrugALKS 2680, 4mg
Oral tablet containing 4 mg of ALKS 2680 for once daily administration
- DrugALKS 2680, 6mg
Oral tablet containing 6 mg of ALKS 2680 for once daily administration
- DrugALKS 2680, 8mg
Oral tablet containing 8 mg of ALKS 2680 for once daily administration
- DrugALKS 2680, 10mg
Oral tablet containing 10 mg of ALKS 2680 for once daily administration
- DrugALKS 2680, 14mg
Oral tablet containing 14 mg of ALKS 2680 for once daily administration
- DrugALKS 2680, 18mg
Oral tablet containing 18 mg of ALKS 2680 for once daily administration
Locations (46)
- Alkermes Investigator SitePhoenix, Arizona
- Alkermes Investigational SiteLittle Rock, Arkansas
- Alkermes Investigational SiteLos Angeles, California
- Alkermes Investigator SiteSan Francisco, California
- Alkermes Investigational SiteStanford, California
- Alkermes Investigational SiteColorado Springs, Colorado