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

Phase 2RecruitingNCT07096674

Centessa Pharmaceuticals (UK) Limited90 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Narcolepsy Type 1 Narcolepsy Type 2 Idiopathic Hypersomnia

Interventions

ORX750DRUG

Oral ORX750

ORX750DRUG

Oral ORX750

ORX750DRUG

Oral ORX750

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Site Number 1

Huntersville, North Carolina, United States

RECRUITING

Outcomes

Primary Outcomes

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

Abnormal Laboratory Tests

Number of Participants With Abnormal Changes From Baseline in Laboratory Tests

Time frame: Up to day 70

Abnormal Vital Signs

Number of Participants With Abnormal Change From Baseline in Vital Signs

Time frame: Up to day 70

Abnormal ECG

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

Time frame: Up to day 70

Suicidal Ideation or Behavior

Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS)

Time frame: Up to day 70

Secondary Outcomes

Cmax

Cmax: Maximum Observed Plasma Concentration for ORX750

Time frame: Up to day 63

Tmax

Tmax: Time of Maximum Concentration for ORX750

Time frame: Up to day 63

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

Central Contacts

Orexin Centessa Program Lead

CONTACT

617-468-5770 ORX750-LTE@centessa.com

Data from ClinicalTrials.gov

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