Ignite Creation Date:
2024-05-06 @ 6:12 PM
Last Modification Date:
2024-10-26 @ 2:43 PM
Study NCT ID:
NCT05583955
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2022-06-16
Brief Title:
A 10-week Efficacy Study of NOE-105 in Childhood Onset Fluency Disorder Orpheus
Sponsor:
Noema Pharma AG
Organization:
Noema Pharma AG
Study Overview
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
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None