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

Centessa Pharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: Narcolepsy Type 2; Idiopathic Hypersomnia; Narcolepsy Type 1

Treatments: Drug: ORX750

Study type: Interventional

Funder types: Industry

Identifiers

NCT07096674

ORX750-202

Details and patient eligibility

About

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).

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Narcolepsy Type 1

Experimental group

Description:

Narcolepsy Type 1 (Open Label)

Treatment:

Drug: ORX750

Drug: ORX750

Drug: ORX750

Narcolepsy Type 2

Experimental group

Description:

Narcolepsy Type 2 (Open Label)

Treatment:

Drug: ORX750

Drug: ORX750

Drug: ORX750

Idiopathic Hypersomnia

Experimental group

Description:

Idiopathic Hypersomnia (Open Label)

Treatment:

Drug: ORX750

Drug: ORX750

Drug: ORX750