A Phase 2 interventional study of ALKS 2680 and Placebo in Narcolepsy Type 1, sponsored by Alkermes, Inc.. Completed at 45 sites in 8 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by Alkermes, Inc. · Phase 2, Interventional, and Treatment
Among 85 studies in Narcolepsy with a site in United States — 19 open to participants now, 20 under way, 8 of them phase 3. Narcolepsy · United States.
Among the 85 studies in Narcolepsy with a site in United States, this one is the 36th largest by enrollment of the 69 interventional ones, is one of 7 that started in 2024, is one of 21 in phase 2, and was the 62nd registered.
157 studies on the registry are indexed under Narcolepsy; 37 are open to participants now.
This study's enrollment of 92 is above the median of 78 across 114 interventional studies indexed under Narcolepsy.
Browse Narcolepsy studies →19 of the 85 studies in Narcolepsy with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 30 Narcolepsy studies recruiting now, 12 (40%) set no upper age limit and 16 (53%) stop at 75 or younger; 12 take children under 18; 6 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →85 studies; the count open now beside each. This study's row is marked.
First in 1996; this study’s year is marked. 7 started in 2024.
Median enrollment 93 across the 69 interventional studies, 191 across the 15 observational. Of the 62 that completed or were terminated, 30 (48%) have results posted.
66 of 85 have an industry lead sponsor. The 10 most frequent:
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.
Alkermes, Inc. has 4 studies filed under Narcolepsy — fewer than ten, so there is no comparison to draw.
11 of the studies in Narcolepsy with a site in United States that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07363720Phase 3TakedaA Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy | 2026-12-17 |
| NCT07455383Phase 3Alkermes, Inc.A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1 | 2027-05 |
| NCT07598708Phase 3Centessa Pharmaceuticals (UK) LimitedA Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence | 2027-09-30 |
| NCT07675135Phase 3Harmony Biosciences Management, Inc.A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy | 2027-10 |
| NCT07540364Phase 3Suven Life Sciences LimitedA Phase 3 Study to Evaluate the Efficacy and Safety of Samelisant in Patients With Narcolepsy (AWAKE) | 2027-11-19 |
Among the 85 studies in Narcolepsy with a site in United States, from their registry updates:
The purpose of this research study is to assess the safety and efficacy of ALKS 2680 compared to placebo, including whether participants taking ALKS 2680 experience a greater decrease in sleepiness and a decrease in cataplexy ("sudden loss of muscle control"), compared to participants taking placebo alone.
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.
Meets the diagnostic criteria of Narcolepsy type 1 according to ICSD-3-TR guidelines. Additionally, meets the following criteria:
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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
Drug: ALKS 2680
Drug: ALKS 2680
Drug: Placebo
Oral tablet of ALKS 2680 for once daily administration
Oral tablet containing matching placebo for once daily administration
Change in Mean Sleep Latency (MSL) on the Maintenance of Wakefulness Test (MWT) from baseline to Week 6
Time frame: Baseline to Week 6
Change in Epworth Sleepiness Scale (ESS) from baseline to Week 6
Epsworth Sleepiness Scale is a 4-point scale used to measure excessive sleepiness from 0 (would never doze) to 3 (high chance of "dozing)
Time frame: Baseline to Week 6
Mean weekly cataplexy rate (WCR) as derived by subject cataplexy diary
Time frame: Measured at Week 5 and 6
Incidence of adverse events
Time frame: Up to 15 Weeks
Plan to share: Undecided
Ran from Mar 2024 to primary completion in Jun 2025, 14 months.
Of 15 phase 2 interventional studies under Narcolepsy, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's 14 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Alixorexton