ALKS 2680 for Narcolepsy and Idiopathic Hypersomnia
A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia
Recruiting
Phase 2Phase 3Interventional Study
Narcolepsy Type 1Narcolepsy Type 2Idiopathic Hypersomnia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
256 (estimated)
Sponsor
Alkermes, Inc. · Industry
Who this trial is looking for
This trial is looking for people with Narcolepsy Type 1, Narcolepsy Type 2, or Idiopathic Hypersomnia who have completed a previous study with ALKS 2680. Participants will take ALKS 2680 tablets and discuss their experience with the treatment.
Are You a Good Fit for This Trial?
You may be able to join if
I have completed a previous study with ALKS 2680.
I can safely stop any medications for narcolepsy for the study duration.
You may not be able to join if
I have developed a new significant health condition.
I am currently pregnant or breastfeeding.
I plan to become pregnant during the study.
I am in another clinical study or used any investigational drug in the last 30 days.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Status
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 t…
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
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