A Phase 2/3 interventional study of ALKS 2680, 4mg and ALKS 2680, 6mg in Narcolepsy Type 1, Narcolepsy Type 2 and Idiopathic Hypersomnia, sponsored by Alkermes, Inc.. Recruiting at 50 sites in 8 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Alkermes, Inc. · Phase 2/3, Interventional, and Treatment
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.
52 studies on the registry are indexed under Idiopathic Hypersomnia; 23 are open to participants now.
This study's planned enrollment of 786 is above the median of 82 across 40 interventional studies indexed under Idiopathic Hypersomnia.
Browse Idiopathic Hypersomnia studies →Alkermes, Inc. is the lead sponsor of 83 studies on the registry; 9 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 5 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 9, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: ALKS 2680, 4mg · Drug: ALKS 2680, 6mg · Drug: ALKS 2680, 8mg
Drug: ALKS 2680, 10mg · Drug: ALKS 2680, 14mg · Drug: ALKS 2680, 18mg
Drug: ALKS 2680, 10mg · Drug: ALKS 2680, 14mg · Drug: ALKS 2680, 18mg
Oral tablet containing 4 mg of ALKS 2680 for once daily administration
Oral tablet containing 6 mg of ALKS 2680 for once daily administration
Oral tablet containing 8 mg of ALKS 2680 for once daily administration
Oral tablet containing 10 mg of ALKS 2680 for once daily administration
Oral tablet containing 14 mg of ALKS 2680 for once daily administration
Oral tablet containing 18 mg of ALKS 2680 for once daily administration
Incidence of Treatment-Emergent Adverse Events
Time frame: Up to 248 Weeks
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 up to week 240
Change in weekly cataplexy rate (WCR)
Time frame: Baseline up to week 240
Change in Idiopathic Hypersomnia Severity Scale (IHSS)
Only applicable for IH participants
Time frame: Baseline up to week 240
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Alixorexton