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

NCT05583955 | Completed Phase 2 Results FDA Drug

• 1 other identifier: NOE-CFD-201
• Study Type: interventional
• Target: 75
• Locations: 2 countries
• Sites: 9

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).

Conditions

Childhood-Onset Fluency Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  43 days

Secondary Outcomes (2)

• Change From Baseline in Sheehan Disability Scale

  Up to 71 days

• Change From Baseline to End Point in Clinician-rated Stuttering Severity Instrument-4

  Up to 71 days

Study Arms (2)

Active

EXPERIMENTAL

Escalating doses of NOE-105 capsules

Drug: NOE-105

Placebo

PLACEBO COMPARATOR

Escalating doses of matching placebo

Drug: Placebo

Interventions

NOE-105 DRUG

Escalating dose levels of NOE-105 will be given and maximum tolerated dose will be maintained

Also known as: Escalating dose levels of NOE-105

Active

Placebo DRUG

Escalating dose levels of matching Placebo will be given

Also known as: Placebo to match

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• BMI within the range 19 to 35 kg/m2 (inclusive).
• 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

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Noema Pharma AG: lead

Study Sites (9)

Noema Investigator site

Bellflower, California, 90706, United States

Location

Noema Investigator site

Jacksonville, Florida, 32256, United States

Location

Noema Investigator site

Orlando, Florida, 32801, United States

Location

Noema Investigator site

Overland Park, Kansas, 66210, United States

Location

Noema Investigator site

Berlin, New Jersey, 08009, United States

Location

Noema Investigator site

Memphis, Tennessee, 38119, United States

Location

Noema Investigator site

Brookvale, New South Wales, 2100, Australia

Location

Noema Investigator site

Miranda, New South Wales, 2228, Australia

Location

Noema Investigator site

Sydney, New South Wales, 2109, Australia

Location

MeSH Terms

Conditions

Childhood-Onset Fluency Disorder

Condition Hierarchy (Ancestors)

Communication Disorders; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Clinical Study Lead
• Organization: Noema Pharma

clinicaltrials@noemapharma.com

+1 646-931-0119

Study Officials

• Gerald A Maguire, M.D.

  Clinical Innovations, Inc. dba CITrials (a CenExel company)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: October 18, 2022
• Study Start: July 25, 2022
• Primary Completion: October 20, 2023
• Study Completion: November 24, 2023
• Last Updated: February 20, 2026
• Results First Posted: February 3, 2026

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (6); AU (3)