A Phase 2, Long-term Extension Study of the Safety and Efficacy of ORX750 in Participants with Narcolepsy and Idiopathic Hypersomnia Who Completed a Sponsored ORX750 Clinical Trial

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-522987-34-00

Enrollment

Registered

2026-02-12

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Narcolepsy and Idiopathic Hypersomnia

Brief summary

Incidence, severity, and causal relationship of treatment emergent adverse events (TEAEs), including serious TEAEs, Changes from baseline in laboratory tests, including biochemistry, hematology, and urinalysis, Changes from baselinea in vital signs and weight, Changes from baseline in 12-lead electrocardiograms (ECGs), Columbia-Suicide Severity Rating Scale (C-SSRS) scores

Detailed description

PK: - Predose and post dose PK concentrations of ORX750 - Other PK parameters as appropriate, Efficacy: o Mean sleep latency (changes from baseline to Day 63) in the MWT (average of the first 4 trials) o Subjective daytime sleepiness (changes from baseline to specified post dose timepoints) using the ESS

Interventions

DRUGORX750

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence, severity, and causal relationship of treatment emergent adverse events (TEAEs), including serious TEAEs, Changes from baseline in laboratory tests, including biochemistry, hematology, and urinalysis, Changes from baselinea in vital signs and weight, Changes from baseline in 12-lead electrocardiograms (ECGs), Columbia-Suicide Severity Rating Scale (C-SSRS) scores	—

Secondary

Measure	Time frame
PK: - Predose and post dose PK concentrations of ORX750 - Other PK parameters as appropriate, Efficacy: o Mean sleep latency (changes from baseline to Day 63) in the MWT (average of the first 4 trials) o Subjective daytime sleepiness (changes from baseline to specified post dose timepoints) using the ESS	—

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 13, 2026