Under construction – not a live service
Sign in
Taking people in ItalyPhase 2

A Long-term Extension Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia

Key facts

Who runs it
Centessa Pharmaceuticals (UK) Limited
Where
Bologna, Pozzilli, and Verona, ItalySee the 3 sitesAlso in 4 other countries, 25 sites
Status
Recruiting
Phase
Phase 2
People taking part
90 people, planned
Started
12 Aug 2025
Planned end
30 Apr 2026
Type of study
Interventional, 3 groups
Treatments tested
  • ORX750
Record updated
16 April 2026

Who can take part

Age
18 years to 65 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 4 criteriaShow less

Who can take part

  • Diagnosis of narcolepsy (NT1 or NT2) or IH who was eligible for and completed the full treatment period in the eligible parent study ORX750-0201 (CRYSTAL-1)
  • Is willing and able to adhere to additional protocol requirements

Who cannot take part

  • Unable to refrain from excluded medications, including those used for treatment of narcolepsy or idiopathic hypersomnia
  • Development of any new disease/disorder that in the opinion of the investigator would make the participant unable to continue the study

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?

Where in Italy

Also in 4 other countries, 25 sites

  • Azienda Unita Sanitaria Locale Di BolognaBologna, ItalyTaking people
  • Istituto Neurologico Mediterraneo Neuromed S.p.A.Pozzilli, ItalyTaking people
  • Centro Ricerche Cliniche di Verona s.r.l.Verona, ItalyTaking people

About the trial

What the trial wants to find out

This study is a long-term extension (LTE) of the parent Study ORX750 0201, and will provide long-term open-label safety, tolerability, and efficacy of ORX750 in participants with narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), and idiopathic hypersomnia (IH).

The 3 groups in the trial

  • Narcolepsy Type 1Treatment being tested

    Narcolepsy Type 1 (Open Label)

    Treatment: ORX750

  • Narcolepsy Type 2Treatment being tested

    Narcolepsy Type 2 (Open Label)

    Treatment: ORX750

  • Idiopathic HypersomniaTreatment being tested

    Idiopathic Hypersomnia (Open Label)

    Treatment: ORX750

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 2, Long-term Extension Study of the Safety and Efficacy of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia Who Completed a Sponsored ORX750 Clinical Trial
Fit questions
Built from NCT07096674, who can take part
Record updated
16 April 2026