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

NCT ID: NCT07096674

Last Updated: 2025-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-12

Study Completion Date

2026-04-30

Brief Summary

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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).

Detailed Description

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Conditions

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Narcolepsy Type 1 Narcolepsy Type 2 Idiopathic Hypersomnia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Open Label Long Term Extension Study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Narcolepsy Type 1

Narcolepsy Type 1 (Open Label)

Group Type EXPERIMENTAL

ORX750

Intervention Type DRUG

Oral ORX750

Narcolepsy Type 2

Narcolepsy Type 2 (Open Label)

Group Type EXPERIMENTAL

ORX750

Intervention Type DRUG

Oral ORX750

Idiopathic Hypersomnia

Idiopathic Hypersomnia (Open Label)

Group Type EXPERIMENTAL

ORX750

Intervention Type DRUG

Oral ORX750

Interventions

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ORX750

Oral ORX750

Intervention Type DRUG

ORX750

Oral ORX750

Intervention Type DRUG

ORX750

Oral ORX750

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centessa Pharmaceuticals (UK) Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Site Number 1

Huntersville, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Orexin Centessa Program Lead

Role: CONTACT

617-468-5770

Other Identifiers

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ORX750-202

Identifier Type: -

Identifier Source: org_study_id

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