NCT05583955

A 10-week Efficacy Study of NOE-105 in Childhood Onset Fluency Disorder (Orpheus)

A Double-blind, Placebo-controlled, Phase IIb, Multi-center, Ten-week Prospective Study to Evaluate the Efficacy and Safety of NOE-105 in Adult Male Patients With Childhood Onset Fluency Disorder (Orpheus)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Noema Pharma AG · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the effectiveness of NOE-105 on speech fluency without the known antipsychotic-induced side effects of commonly used treatments for childhood onset fluency disorder (COFD).

Detailed description

NOE-105 is an investigational selective PDE10A inhibitor with a potential therapeutic effect for the treatment of COFD. In this study adult male patients may be randomized to a double-blind, placebo-controlled, parallel group treatment with NOE-105 or placebo once daily. The study is designed to find the maximum tolerated dose of NOE-105 and thereafter, to maintain the participants at this dose until they have completed a total of 10 weeks treatment period. Following up to 10 weeks of treatment, participants will visit the study site for a follow-up visit within 28 (± 7) days of the date of the last dose of study treatment.

Conditions

• Childhood-Onset Fluency Disorder

Interventions

Type	Name	Description
DRUG	NOE-105	Escalating dose levels of NOE-105 will be given and maximum tolerated dose will be maintained
DRUG	Placebo	Escalating dose levels of matching Placebo will be given

Timeline

• Start date: 2022-07-25
• Primary completion: 2023-10-20
• Completion: 2023-11-24
• First posted: 2022-10-18
• Last updated: 2026-02-20
• Results posted: 2026-02-03

Locations

9 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study