A Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCentessa Pharmaceuticals (UK) Limited

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • ORX750

    Drug

    ORX750 capsule.

  • Placebo

    Drug

    ORX750 matching placebo capsule.

Treatment groups

248 Participants
are divided into 3 treatment groups
Group A: Narcolepsy Type 1: ORX750 and PlaceboExperimental treatment 2 interventions
Group B: Narcolepsy Type 2: ORX750 and PlaceboExperimental treatment 2 interventions
Group C: Idiopathic Hypersomnia: ORX750 and PlaceboExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs

Time frame
Up to Day 35
2

Number of Participants With Abnormal Changes From Baseline in Laboratory Tests

Time frame
Up to Day 35
3

Number of Participants With Abnormal Change From Baseline in Vital Signs

Time frame
Up to Day 35
4

Number of Participants With Abnormal Change From Baseline in Electrocardiograms (ECG)

Time frame
Up to Day 35

Secondary outcomes

1

Cmax: Maximum Observed Plasma Concentration for ORX750

Time frame
Day 1, 15, 28
2

Tmax: Time of Maximum Concentration for ORX750

Time frame
Day 1, 15, 28
3

AUC0last: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for ORX750

Time frame
up to Day 28
4

Cmax,ss: Maximum Observed Concentration at Steady State for ORX750

Time frame
Day 1, 15, 28

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.