Childhood-Onset Fluency DisorderPhase 2NCT05583955
A 10-week Efficacy Study of NOE-105 in Childhood Onset Fluency Disorder (Orpheus)
A Phase 2 study testing NOE-105 in people with Childhood-Onset Fluency Disorder, run by Noema Pharma AG at 9 sites in 2 countries.
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). Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Childhood-Onset Fluency Disorder
- What is being tested?
- NOE-105
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 25 Jul 2022to 24 Nov 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Patients must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
- Patients who satisfy DSM-5 criteria for childhood onset fluency disorder and are suitable for pharmacotherapy.
- Have a history of stuttering for more than or equal to ≥ 2 years with onset consistent to developmental in nature before age 8 years.
- Patient reported global stuttering experience as "moderate" at screening and baseline.
- 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.
- BMI within the range 19 to 35 kg/m2 (inclusive).
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- 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.
- Capable of giving signed informed consent
- Able to read and write in English
Who cannot join
- Stuttering is related to a known neurological cause eg, stroke, etc.
- Low IQ in the opinion of the investigator.
- Patients with uncontrolled seizure disorders.
- A history of severe traumatic brain injury or stroke.
- Patients who are, in the investigator's opinion, at imminent risk of suicide.
- Known to have tested positive for human immunodeficiency virus.
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- Known DSM-5 diagnosis of substance abuse or dependence.
- Unstable medical illness or clinically significant abnormalities on screening tests/exams.
- 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.
- Initiation of new behavioral therapies for stuttering within 10 weeks prior to baseline.
- Use of antipsychotic drug therapy within 14 days prior to receiving treatment until the EoT visit.
- Participation in another clinical study with an IP administered in the last 30 days.
- Participants with a known hypersensitivity to NOE-105 or any of the excipients of the product.
- Patient must not intend to use cannabinoids, cocaine, or nonprescribed opiates.
- Involvement in the planning and/or conduct of the study (applies to both Noema staff and/or staff at the study site).
- Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
- Previous randomization in the present study.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States6 sites
Noema Investigator site
Bellflower, California, 90706
Noema Investigator site
Berlin, New Jersey, 08009
Noema Investigator site
Jacksonville, Florida, 32256
Noema Investigator site
Memphis, Tennessee, 38119
Noema Investigator site
Orlando, Florida, 32801
Noema Investigator site
Overland Park, Kansas, 66210
Australia3 sites
Noema Investigator site
Brookvale, New South Wales, 2100
Noema Investigator site
Miranda, New South Wales, 2228
Noema Investigator site
Sydney, New South Wales, 2109
About this study
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)
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).
Read the 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.
- Conditions
- Childhood-Onset Fluency Disorder
- Being tested
- NOE-105, Placebo
- Medical subject headings
- Childhood-Onset Fluency Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOE-105Drug
Also called Escalating dose levels of NOE-105
Escalating dose levels of NOE-105 will be given and maximum tolerated dose will be maintained
PlaceboDrug
Also called Placebo to match
Escalating dose levels of matching Placebo will be given
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Escalating doses of NOE-105 capsules Receives: Drug: NOE-105 |
| Placebo | Placebo comparator | Escalating doses of matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to End of 6 Weeks in Total MLGSSS
MLGSSS refers to Maguire-Leal-Garibaldi Self-rated Stuttering Scale. The scale includes ten questions that are assessed on a 0 to 10 scale with 0 being no impact and 10 being highest impact. The total score ranges from 0 to 100 with the higher the score the worse the stuttering.
Measured: 43 days
Secondary outcomes (2)
Change From Baseline in Sheehan Disability Scale
The Sheehan Disability Scale (SDS) is a brief, self-report tool that assesses disability or functional impairment in the domains of (1) Work/School life, (2) Social life, and (3) Family life/home responsibilities. Each is assessed on a 10 point scale with 0 being no impact, and 10 being highest impact. Each item is rated from 0 (not at all) to 10 (extremely) impairment. Each domain score is added to provide a total score from 0-30 total score with 0 (no impairment) and 30 is severe impairment. The change from the Baseline assessment have been provided.
Measured: Up to 71 days
Change From Baseline to End Point in Clinician-rated Stuttering Severity Instrument-4
SSI-4 is a validated scale to evaluate speech fluency including frequency, duration, physical concomitants and the naturalness of the speech. The score ranges from 10 (mildest) to 46 (most severe). The results show the change from Baseline in the SSI-4
Measured: Up to 71 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start25 Jul 2022
- Primary completion20 Oct 2023
- Study completion24 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Childhood-Onset Fluency DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noema Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gerald A Maguire, M.D., Principal investigator, Clinical Innovations, Inc. dba CITrials (a CenExel company)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583955
- Sponsor's protocol ID
- NOE-CFD-201
- Status last verified
- Mar 2024
- First submitted
- 16 Jun 2022
- Last updated
- 20 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05583955
- Acronym / sponsor ID
- NOE-CFD-201
- Conditions
- Childhood-Onset Fluency Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Noema Pharma AGIndustry (pharma, biotech, devices)
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 20 Oct 2023 (actual)
- Study completion
- 24 Nov 2023 (actual)
- First posted
- 18 Oct 2022 (actual)
- Results
- Posted 3 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: NOE-105Escalating doses of NOE-105 capsules |
| Placebo | Placebo comparator | Drug: PlaceboEscalating doses of matching placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Patients must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
- Patients who satisfy DSM-5 criteria for childhood onset fluency disorder and are suitable for pharmacotherapy.
- Have a history of stuttering for more than or equal to ≥ 2 years with onset consistent to developmental in nature before age 8 years.
- Patient reported global stuttering experience as "moderate" at screening and baseline.
- 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.
Key exclusion criteria (17 listed)
- Stuttering is related to a known neurological cause eg, stroke, etc.
- Low IQ in the opinion of the investigator.
- Patients with uncontrolled seizure disorders.
- A history of severe traumatic brain injury or stroke.
- Patients who are, in the investigator's opinion, at imminent risk of suicide.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NOE-105Also: Escalating dose levels of NOE-105Escalating dose levels of NOE-105 will be given and maximum tolerated dose will be maintained | Drug | Active |
| PlaceboAlso: Placebo to matchEscalating dose levels of matching Placebo will be given | Drug | Placebo |
Primary outcome
Change From Baseline to End of 6 Weeks in Total MLGSSS
Time frame: 43 days
MLGSSS refers to Maguire-Leal-Garibaldi Self-rated Stuttering Scale. The scale includes ten questions that are assessed on a 0 to 10 scale with 0 being no impact and 10 being highest impact. The total score ranges from 0 to 100 with the higher the score the worse the stuttering.
2 secondary outcomes
Change From Baseline in Sheehan Disability Scale
Time frame: Up to 71 days
Change From Baseline to End Point in Clinician-rated Stuttering Severity Instrument-4
Time frame: Up to 71 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Childhood-Onset Fluency Disorder
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Stuttering, Adult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerald A Maguire, M.D. principal investigator
Clinical Innovations, Inc. dba CITrials (a CenExel company)
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NOE-105 in people with Childhood-Onset Fluency Disorder, run by Noema Pharma AG at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to End of 6 Weeks in Total MLGSSS (time frame: 43 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.