NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia

RecruitingPhase 2, Phase 3

Sponsor: Alkermes, Inc.

Conditions: Narcolepsy Type 1, Narcolepsy Type 2, Idiopathic Hypersomnia

Interventions: ALKS 2680, 4mg, ALKS 2680, 6mg, ALKS 2680, 8mg, ALKS 2680, 10mg, ALKS 2680, 14mg

Countries: United States, Australia, Belgium, Czechia, France, Italy, Netherlands, Spain

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 overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (49)

Cullman, Alabama, United States
Phoenix, Arizona, United States
Little Rock, Arkansas, United States
Los Angeles, California, United States
San Francisco, California, United States
Stanford, California, United States
Boulder, Colorado, United States
Colorado Springs, Colorado, United States
Brandon, Florida, United States
Miami, Florida, United States
Winter Park, Florida, United States
Atlanta, Georgia, United States
Macon, Georgia, United States
Stockbridge, Georgia, United States
Peoria, Illinois, United States
Kansas City, Kansas, United States
Lansing, Michigan, United States
Sterling Heights, Michigan, United States
Lincoln, Nebraska, United States
Middletown, New Jersey, United States
Denver, North Carolina, United States
Huntersville, North Carolina, United States
Canton, Ohio, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Dublin, Ohio, United States
Abington, Pennsylvania, United States
Wyomissing, Pennsylvania, United States
Columbia, South Carolina, United States
Austin, Texas, United States
+ 19 more on CT.gov