ALKS 2680 for adults with Narcolepsy Type 2

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3, randomized interventional trial compares three doses of ALKS 2680 tablets with placebo in adults diagnosed with Narcolepsy Type 2. Participants must have NT2 confirmed by PSG/MSLT and will follow study requirements including actigraphy, sleep diaries, and adherence to any primary OSA therapy. The trial measures changes in daytime sleepiness and core disease symptoms across treatment arms. Study visits occur at Alkermes investigational sites in Florida, Georgia, and Michigan.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Is willing and able, in the opinion of the Investigator, to understand and comply with protocol requirements, including the following: lifestyle considerations and restrictions, adherence to contraception guidance, adherence to actigraphy and diary requirements, if receiving treatment for OSA, adherence to primary OSA therapy over the 30 days prior to Visit 1, and throughout the study, including during overnight visits.
* Meets the diagnostic criteria of NT2 according to ICSD-3-TR guidelines, confirmed by diagnostic evaluations (either PSG/MSLT).

Exclusion Criteria:

* Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle.
* Has a history or presence of other clinically significant (treated or untreated) illness, disease, abnormality, or surgical procedure that, in the opinion of the Investigator, might compromise participant safety, interfere with any study assessment, or affect the participant's ability to complete the study.
* Is currently enrolled in another interventional clinical trial or has received any investigational drug or used any interventional investigational device within 30 days prior to Visit 1. Participants previously enrolled in Study ALKS 2680-202 are not eligible for enrollment.
* Is currently pregnant, breastfeeding, or is planning to become pregnant during the study

Where it's running

• Alkermes Investigational Site
  Cullman, Alabama, United States Recruiting
• Alkermes Investigational Site
  Phoenix, Arizona, United States Recruiting
• Alkermes Investigational Site
  Los Angeles, California, United States Recruiting
• Alkermes Investigational Site
  Boulder, Colorado, United States Recruiting
• Alkermes Investigational Site
  Brandon, Florida, United States Recruiting
• Alkermes Investigational Site
  Maimi, Florida, United States Recruiting

Study contacts

• Study coordinator: Director Clinical Trial Manager
• Email: clinicaltrials@alkermes.com
• Phone: 888-235-8008 (US Only)

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Long-term test of TAK-360 in people with narcolepsy or idiopathic hypersomnia

  This study tests TAK-360 over an extended period to see if it is tolerable for people with narcolepsy type 1, narcolepsy type 2, or idiopathic hypersomnia who completed an earlier TAK-360 trial.

  Recruiting at 33 sites Phase 2/3 Takeda · Chula Vista, California and 32 other locations · NCT07646678

• Test of Cleminorexton vs placebo for central hypersomnolence in NT1/NT2

  This study tests cleminorexton to see if it helps daytime sleepiness in adults with Narcolepsy Type 1 or Type 2 compared with a placebo.

  Recruiting at 26 sites Phase 2/3 Centessa Pharmaceuticals plc · Birmingham, Alabama and 25 other locations · NCT07598708

• Long-term ORX750 treatment for people with narcolepsy or idiopathic hypersomnia

  This open-label extension will try continued ORX750 treatment in people with narcolepsy or idiopathic hypersomnia who completed the earlier ORX750 parent study.

  Recruiting at 24 sites Phase 2 Centessa Pharmaceuticals (UK) Limited · Auburn, Alabama and 23 other locations · NCT07096674

• Evaluating TAK-360 for adults with Narcolepsy Type 2

  This study is testing a new medication called TAK-360 to see if it can help adults with Narcolepsy Type 2 stay awake during the day.

  Recruiting at 44 sites Phase 2 Takeda · Auburn, Alabama and 51 other locations · NCT06952699

• Long-term treatment with ALKS 2680 for narcolepsy and idiopathic hypersomnia

  This study is testing how well a new medication called ALKS 2680 works for people with narcolepsy or idiopathic hypersomnia over a long period of time.

  Recruiting at 50 sites Phase 2/3 Alkermes, Inc. · Cullman, Alabama and 49 other locations · NCT06767683

• Testing ORX750 for Narcolepsy and Idiopathic Hypersomnia

  This study is testing a new medication called ORX750 to see if it can help people with narcolepsy or idiopathic hypersomnia feel more awake and improve their daily lives.

  Recruiting at 37 sites Phase 2 Centessa Pharmaceuticals plc · Auburn, Alabama and 36 other locations · NCT06752668

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.