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

ConditionsNarcolepsy Type 1Narcolepsy Type 2Idiopathic Hypersomnia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCentessa Pharmaceuticals (UK) Limited

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • ORX750

    Drug

    Oral ORX750

  • ORX750

    Drug

    Oral ORX750

  • ORX750

    Drug

    Oral ORX750

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Narcolepsy Type 1Experimental treatment 1 intervention
Group B: Narcolepsy Type 2Experimental treatment 1 intervention
Group C: Idiopathic HypersomniaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs

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

Time frame
Up to day 70
2

Abnormal Laboratory Tests

Number of Participants With Abnormal Changes From Baseline in Laboratory Tests

Time frame
Up to day 70
3

Abnormal Vital Signs

Number of Participants With Abnormal Change From Baseline in Vital Signs

Time frame
Up to day 70
4

Abnormal ECG

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

Time frame
Up to day 70

Secondary outcomes

1

Cmax

Cmax: Maximum Observed Plasma Concentration for ORX750

Time frame
Up to day 63
2

Tmax

Tmax: Time of Maximum Concentration for ORX750

Time frame
Up to day 63
3

AUClast

AUClast: 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 63
4

Cmax,ss

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

Time frame
Up to day 63

Other outcomes

Sponsors and contacts

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

Centessa Pharmaceuticals (UK) Limited

Lead sponsor

Source ClinicalTrials.gov
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