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

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 study evaluates the long-term safety, tolerability, and effectiveness of ALKS 2680 in patients diagnosed with Narcolepsy Type 1, Narcolepsy Type 2, or Idiopathic Hypersomnia. Participants who have completed a prior study involving ALKS 2680 will receive varying doses of the medication to assess its impact over an extended period. The study aims to determine how well the treatment works in managing symptoms associated with these sleep disorders.

Why it matters

Who can join: the full rules

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), ALKS 2680-302 (Brilliance NT1) , ALKS 2680-303 (Brilliance NT2) , ALKS 2680-304 (Brilliance NT 1)
* 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

Where it's running

• Alkermes Investigational Site
  Cullman, Alabama, United States Recruiting
• Alkermes Investigator Site
  Phoenix, Arizona, United States Recruiting
• Alkermes Investigational Site
  Little Rock, Arkansas, United States Recruiting
• Alkermes Investigational Site
  Los Angeles, California, United States Recruiting
• Alkermes Investigator Site
  San Francisco, California, United States Recruiting
• Alkermes Investigational Site
  Stanford, California, United States Recruiting

Study contacts

• Study coordinator: Director, Global Clinical Services
• 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

• 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

• 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

• 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

• Understanding how food intake affects sleep in narcolepsy and hypersomnia patients

  This study is testing how what people eat affects their sleep and daytime sleepiness in patients with narcolepsy and hypersomnia to find better ways to manage their health.

  Recruiting Hospices Civils de Lyon · Clermont-Ferrand and 1 other locations · NCT06484348

• Exploring mind-wandering and its effects in narcolepsy and hypersomnolence

  This study is testing how daydreaming affects thinking and creativity in people with narcolepsy and excessive sleepiness.

  Recruiting Hospices Civils de Lyon · Lyon · NCT06457945

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.