A Phase 3 interventional study of ALKS 2680 Dose 1 and ALKS 2680 Dose 2 in Narcolepsy Type 1, sponsored by Alkermes, Inc.. Recruiting at 20 sites in 5 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Alkermes, Inc. · Phase 3, Interventional, and Treatment
The purpose of this study is to measure decreases in daytime sleepiness, cataplexy (sudden loss of muscle tone), and disease symptoms in participants with NT1 when taking ALKS 2680 tablets compared with placebo tablets.
92 studies on the registry are indexed under Sleepiness; 20 are open to participants now.
This study's planned enrollment of 150 is above the median of 62 across 62 interventional studies indexed under Sleepiness.
Browse Sleepiness 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.
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 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.
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 Dose 1
Drug: ALKS 2680 Dose 2
Drug: Placebo
Participants will receive ALKS 2680 tablets, daily, orally, for 12 weeks
Also known as: Alixorexton
Participants will receive ALKS 2680 tablets, daily, orally, for 12 weeks
Also known as: Alixorexton
Participants will receive placebo tablets, daily, orally for 12 weeks
Change in mean sleep latency (MSL) on Maintenance of Wakefulness Test (MWT) from baseline to Week 12 by dose level
Time frame: Baseline to Week 12
Change in Epworth Sleepiness Scale (ESS) from baseline to Week 12 by dose level
Time frame: Baseline to Week 12
Weekly cataplexy rate (WCR) at Week 12 by dose level
Time frame: Week 12
Percentage of participants who achieve a status of "none" or "mild" on Patient Global Impression- Severity (PGI-S) scale(general disease) at Week 12 by dose level
Time frame: Week 12
Change in British Columbia Cognitive Complaints Inventory (BC-CCI) from baseline to Week 12 by dose level
Time frame: Baseline to Week 12
Change in number of lapses on Psychomotor Vigilance Task (PVT) from baseline to Week 12 by dose level
Time frame: Baseline to Week 12
Change in Patient-Reported Outcomes Measurement Information System - Fatigue 6a (PROMIS Fatigue 6a) from baselineto Week 12 by dose level
Time frame: Baseline to Week 12
Percentage of participants who achieve a status of "normal, not ill at all", "borderline ill", or "mildly ill" on Clinical Global Impression-Severity (CGI-S) (general disease) at Week 12 by dose level
Time frame: Week 12
Change in Narcolepsy Severity Scale for Clinical Trials (NSS-CT) from baseline to Week 12 by dose level
Time frame: Baseline to Week 12
Incidence of treatment emergent adverse events
Time frame: Baseline to Week 14
Plan to share: Undecided
Started Aug 2026 (actual). Primary completion is estimated for Jun 2027, 10 months after the start.
How these figures are worked out, and which studies are left out of them.
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 ↗
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