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COMPLETEDPHASE2

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)

NCT05583955•Noema Pharma AG

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 55 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. Patients must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
•2. Patients who satisfy DSM-5 criteria for childhood onset fluency disorder and are suitable for pharmacotherapy.
•3. Have a history of stuttering for more than or equal to ≥ 2 years with onset consistent to developmental in nature before age 8 years.
•4. Patient reported global stuttering experience as "moderate" at screening and baseline.
•5. Patients must discontinue all medications used to treat stuttering for at least 14 days prior to receiving study treatment. With the exception of antipsychotic therapies (see exclusion criterion #11), other psychotropic drugs will be allowed provided they have been stable for at least 14 days prior to receiving study treatment and are expected to remain stable for the duration of the study.
•6. BMI within the range 19 to 35 kg/m2 (inclusive).
•7. Male Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
•Male patients must use a condom during the treatment period and until the end of relevant systemic exposure in the male participant, plus a further 90-day period. In addition, for a non-pregnant WOCBP partner.
•8. Capable of giving signed informed consent
•9. Able to read and write in English

Exclusion Criteria

•1. Stuttering is related to a known neurological cause eg, stroke, etc.
•2. Low IQ in the opinion of the investigator.
•3. Patients with uncontrolled seizure disorders.
•4. A history of severe traumatic brain injury or stroke.
•5. Patients who are, in the investigator's opinion, at imminent risk of suicide.
•6. Known to have tested positive for human immunodeficiency virus.
•7. Known DSM-5 diagnosis of substance abuse or dependence.
•8. Unstable medical illness or clinically significant abnormalities on screening tests/exams.
•9. Any unstable medical conditions or are currently ill (eg, congenital heart disease, arrhythmia or cancer), which, in the investigator's judgment, will put them at a risk of major adverse event during this trial, are expected to progress during the study, or will interfere with safety and efficacy assessments.
•10. Initiation of new behavioral therapies for stuttering within 10 weeks prior to baseline.
+7 more criteria

Locations (9)

Noema Investigator site

Bellflower, California, United States

Noema Investigator site

Jacksonville, Florida, United States

Noema Investigator site

Orlando, Florida, United States

Noema Investigator site

Overland Park, Kansas, United States

Noema Investigator site

Berlin, New Jersey, United States

Noema Investigator site

Memphis, Tennessee, United States

Noema Investigator site

Brookvale, New South Wales, Australia

Noema Investigator site

Miranda, New South Wales, Australia

Noema Investigator site

Sydney, New South Wales, Australia

Key Dates

Start Date

July 25, 2022

Primary Completion Date

October 20, 2023

Completion Date

November 24, 2023

Last Updated

February 20, 2026

Enrollment

ACTUAL participants

Conditions

Childhood-Onset Fluency Disorder

Interventions

NOE-105

DRUG

Placebo

DRUG

Stimulation of the Thalamus to Ameliorate Persistent Disfluency

NCT05641701

Persistent Developmental StutterChildhood-Onset Fluency Disorder (Stuttering)

View study

COMPLETEDPHASE2

Effects of Ecopipam or Placebo in Adults With Stuttering (Speak Freely)

NCT04492956

Childhood-Onset Fluency Disorder (Stuttering)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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