Testing ORX750 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 clinical trial evaluates the efficacy of ORX750 in treating participants diagnosed with Narcolepsy Type 1, Narcolepsy Type 2, or Idiopathic Hypersomnia, conditions characterized by excessive daytime sleepiness. Participants aged 18-65 will be recruited and must be willing to discontinue any current medications for their conditions. The study will compare the effects of ORX750 against a placebo to determine its potential benefits in improving alertness and daily functioning. The trial aims to gather data on how well ORX750 can alleviate symptoms associated with these sleep disorders.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 18-65 years of age
* BMI ≥17 and ≤37 kg/m2
* Meets the diagnostic criteria of Narcolepsy Type 1 (NT1), Type 2 (NT2) or Idiopathic Hypersomnia (IH) according to ICSD-3-TR criteria
* Is willing and able to discontinue all medications used for the treatment of narcolepsy or idiopathic hypersomnia
* Is willing and able to adhere to additional protocol requirements

Exclusion Criteria:

* A medical disorder other than NT1, NT2, or IH that is associated with excessive daytime sleepiness (EDS).
* Presence of significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, hematological, malignancy, endocrine, neurological or psychiatric disease

Where it's running

• Auburn, Alabama
  Auburn, Alabama, United States Recruiting
• Chandler, Arizona
  Chandler, Arizona, United States Recruiting
• Scottsdale, Arizona
  Scottsdale, Arizona, United States Recruiting
• Long Beach, California
  Long Beach, California, United States Recruiting
• Santa Ana, California
  Santa Ana, California, United States Recruiting
• Brandon, Florida
  Brandon, Florida, United States Recruiting

Study contacts

• Study coordinator: Centessa Pharmaceuticals
• Email: CRYSTAL-1@centessa.com
• Phone: +1 617-468-5770

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

• 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

• 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.