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NOE-105 for Stuttering

Phase 2
Waitlist Available
Led By Gerald A Maguire, M.D.
Research Sponsored by Noema Pharma AG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 71 days
Awards & highlights

Study Summary

This trial tests a new drug to help kids with stuttering, without having the side effects of existing treatments.

Who is the study for?
This trial is for individuals aged 18-55 with childhood onset fluency disorder (stuttering) that started before age 8 and has lasted at least 2 years. Participants must not be on stuttering medication or antipsychotics for 14 days prior, have a stable weight (BMI of 19-35), use contraception if male, and be able to consent in English. Excluded are those with neurological causes of stuttering, low IQ, uncontrolled seizures, severe brain injury or stroke, imminent suicide risk, HIV positive status, substance abuse disorders, unstable medical conditions or recent participation in other drug trials.Check my eligibility
What is being tested?
The study tests NOE-105 against a placebo over ten weeks to see if it improves speech fluency without the side effects associated with current treatments for stuttering. The participants will randomly receive either NOE-105 or a placebo to determine its effectiveness compared to no treatment.See study design
What are the potential side effects?
While specific side effects of NOE-105 are not listed here as it's under evaluation, commonly monitored adverse reactions may include allergic responses to the drug's components and potential unknown risks due to its newness.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 71 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 71 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline to end point in severity subset of the MLGSSS
Change in clinical chemistry
Change in the hematological parameters
+3 more
Secondary outcome measures
CGI-C rating at end point
Change from baseline to end point in SDS
Stuttering
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ActiveExperimental Treatment1 Intervention
Escalating doses of NOE-105 capsules
Group II: PlaceboPlacebo Group1 Intervention
Escalating doses of matching placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NOE-105
2022
Completed Phase 2
~80

Find a Location

Who is running the clinical trial?

Noema Pharma AGLead Sponsor
5 Previous Clinical Trials
488 Total Patients Enrolled
Gerald A Maguire, M.D.Principal InvestigatorClinical Innovations, Inc. dba CITrails (a CenExel company)

Media Library

NOE-105 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05583955 — Phase 2
Stuttering Research Study Groups: Active, Placebo
Stuttering Clinical Trial 2023: NOE-105 Highlights & Side Effects. Trial Name: NCT05583955 — Phase 2
NOE-105 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05583955 — Phase 2
Stuttering Patient Testimony for trial: Trial Name: NCT05583955 — Phase 2
~26 spots leftby May 2025
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