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

NCT05583955 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-02-20

Study results available
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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).

Conditions

  • Childhood-Onset Fluency Disorder

Interventions

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

Sponsors & Collaborators

  • Noema Pharma AG

    lead INDUSTRY

Principal Investigators

  • Gerald A Maguire, M.D. · Clinical Innovations, Inc. dba CITrials (a CenExel company)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-25
Primary Completion
2023-10-20
Completion
2023-11-24
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05583955 on ClinicalTrials.gov