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

Childhood-Onset Fluency Disorder Clinical Trial

Official title: 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

Clinical Trial 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).

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Childhood-Onset Fluency Disorder

• NCT number: NCT05583955
• Study type: Interventional
• Source: Noema Pharma AG
• Status: Completed
• Phase: Phase 2
• Start date: July 25, 2022
• Completion date: November 24, 2023