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

Detailed 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 h…

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

Locations (49)

Alkermes Investigational Site
Cullman, Alabama
Alkermes Investigator Site
Phoenix, Arizona
Alkermes Investigational Site
Little Rock, Arkansas
Alkermes Investigational Site
Los Angeles, California
Alkermes Investigator Site
San Francisco, California
Alkermes Investigational Site
Stanford, California