At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 75 enrolled
Drug / intervention
NOE-105 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating NOE-105 and Placebo for Childhood-Onset Fluency Disorder. Completed, enrolled 75 participants across 9 sites in 2 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChildhood-Onset Fluency Disorder
CountriesAustralia, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2023202420252026
Enrollment StartJul 2022
First PostedOct 2022
Primary CompletionOct 2023
Study CompletionNov 2023
TodayJul 2026
First PostedOct 18, 2022
Enrollment StartJul 25, 2022
Primary CompletionOct 20, 2023
Study CompletionNov 24, 2023
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 3.7 years ago
Interventions
NOE-105drug
Escalating dose levels of NOE-105 will be given and maximum tolerated dose will be maintained
Placebodrug
Escalating dose levels of matching Placebo will be given