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

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.
• •11. Use of antipsychotic drug therapy within 14 days prior to receiving treatment until the EoT visit.
• •12. Participation in another clinical study with an IP administered in the last 30 days.
• •13. Participants with a known hypersensitivity to NOE-105 or any of the excipients of the product.
• •14. Patient must not intend to use cannabinoids, cocaine, or nonprescribed opiates.
• •15. Involvement in the planning and/or conduct of the study (applies to both Noema staff and/or staff at the study site).
• •16. 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.
• •17. Previous randomization in the present study.