Idiopathic Hypersomnia, Narcolepsy Type 1, Narcolepsy Type 2
Conditions
Keywords
NT1, NT2, IH, Narcolepsy, Narcolepsy Type 1, Narcolepsy Type 2, Idiopathic Hypersomnia, Excessive Daytime Sleepiness, Orexin Receptor 2 agonist
Brief summary
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).
Interventions
DRUGORX750
Oral ORX750
Sponsors
Centessa Pharmaceuticals (UK) Limited
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open Label Long Term Extension Study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Development of any new disease/disorder that in the opinion of the investigator would make the participant unable to continue the study * Unable to refrain from excluded medications, including those used for treatment of narcolepsy or idiopathic hypersomnia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | Up to day 70 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs |
| Abnormal Laboratory Tests | Up to day 70 | Number of Participants With Abnormal Changes From Baseline in Laboratory Tests |
| Abnormal Vital Signs | Up to day 70 | Number of Participants With Abnormal Change From Baseline in Vital Signs |
| Abnormal ECG | Up to day 70 | Number of Participants With Abnormal Change From Baseline in Electrocardiograms (ECG) |
| Suicidal Ideation or Behavior | Up to day 70 | Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | Up to day 63 | Cmax: Maximum Observed Plasma Concentration for ORX750 |
| Tmax | Up to day 63 | Tmax: Time of Maximum Concentration for ORX750 |
| AUClast | Up to day 63 | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for ORX750 |
| Cmax,ss | Up to day 63 | Cmax,ss: Maximum Observed Concentration at Steady State for ORX750 |
| AUCτ | Up to day 63 | AUCτ: Area Under the Concentration-time Curve During a Dosing Interval at Steady State for ORX750 |
| Maintenance of Wakefulness Test | Up to day 63 | Change From Baseline in Mean sleep latency (average of the first 4 trials) in the Maintenance of Wakefulness Test (MWT) |
| Epworth Sleepiness Scale | Up to day 63 | Change From Baseline in Epworth Sleepiness Scale (ESS) |
Countries
Canada, Italy, Spain, United States
Contacts
CONTACTOrexin Centessa Program Lead
Outcome results
None listed