ORX750
DrugORX750 capsule.
NCT Number: NCT06752668
Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), and Idiopathic Hypersomnia (IH) are rare conditions that make people feel very sleepy during the day (often referred to as excessive daytime sleepiness [EDS]). People living with these conditions might find it hard to stay alert and pay attention when they are at school, working, driving, or performing other daily activities.
While all conditions result in feeling sleepy, there are some differences in other common symptoms:
* NT1: People with NT1 often feel very tired during the day and experience cataplexy. Cataplexy is a sudden loss of muscle strength, which can cause someone to collapse or lose control of their muscles for a short time. This is often triggered by strong emotions, such as laughter or surprise. They may also have trouble sleeping well at night. * NT2: People with NT2 feel sleepy during the day, just like NT1, but they do not have cataplexy. * IH: People with IH feel tired during the day, even after sleeping a lot at night. They may sleep for long periods, take long naps, and find it hard to wake up.
Orexin is a protein in the brain that helps coordinate a system that plays an important role in helping people to stay awake during the daytime. Cleminorexton (also known as ORX750) is designed to mimic the action of orexin. The purpose of this study is to see how safe and tolerable ORX750 is in NT1, NT2, and IH, and learn about what the drug does to the body. Another goal of the study is to see if ORX750 can help people with NT1, NT2, and IH feel less sleepy and make other symptoms better.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Phase 2
Toronto, Ontario, Toronto, Ontario, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ORX750 capsule.
ORX750 matching placebo capsule.
Time frame: Up to Day 35
Time frame: Up to Day 35
Time frame: Up to Day 35
Time frame: Up to Day 35
Time frame: Up to Day 35
Time frame: Day 1, 15, 28
Time frame: Day 1, 15, 28
Time frame: up to Day 28
Time frame: Day 1, 15, 28
Time frame: Day 1, 15, 28
Time frame: Baseline up to Day 28
Mean sleep latency is determined by averaging the time to falling asleep across trials
Time frame: Baseline up to Day 28
Contact information is provided by the study sponsor or research team.
Centessa Pharmaceuticals (UK) Limited
Industry
A Phase 2a, Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ORX750 in Subjects With Narcolepsy and Idiopathic Hypersomnia (CRYSTAL-1)
Acronym: CRYSTAL-1
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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