A Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia

Launched by CENTESSA PHARMACEUTICALS (UK) LIMITED · Dec 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called ORX750 to see how safe it is and how well it works for people with narcolepsy (both types 1 and 2) and idiopathic hypersomnia, a condition that causes excessive daytime sleepiness. The trial is currently looking for participants aged 18 to 65 who have been diagnosed with one of these sleep disorders and are willing to stop taking their current medications for these conditions.

If you or someone you know qualifies and decides to participate, you will be closely monitored throughout the study to see how ORX750 affects your sleepiness and overall health. This trial is important because it could help find better treatments for those struggling with these disorders. Participants will need to follow specific requirements and attend appointments, but the details will be explained thoroughly before you join.

Gender

ALL

Eligibility criteria

• 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