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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
4 Previous Clinical Trials
464 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research venture accept participants aged 85 and above?

"According to the entrance criteria for this medical trial, participants must be between 18 and 55 years of age."

Answered by AI

What is the prevalence of medical institutions running this trial in the state?

"This trial is running from eight different locations, including CNS Healthcare - Orlando in Florida, CNS Halthcare - Jacksonville in California and Doctors One Healthcare System Corporation in Kansas."

Answered by AI

To whom does eligibility for this research extend?

"This medical trial is recruiting 67 adults, aged 18 to 55 years old, who present with fluency disorder diagnosed in childhood. To qualify for the study, patients must meet a number of criteria including: fulfilment of DSM-5 guidelines indicating childhood onset fluency disorder and being suitable for pharmacotherapy; having experienced stuttering for 2 or more years prior to 8 years old; reporting moderate global stuttering experience at screening and baseline visits; discontinuation of all medications used to treat stuttering 14 days before receiving treatment (except antipsychotics); BMI between 19 - 35 kg/m2; male contraceptive use adhering to local regulations regarding"

Answered by AI

How many people have registered for this experiment?

"Affirmative. Information posted on clinicaltrials.gov confirms that this medical trial, which was initially listed on July 25th 2022, is currently recruiting patients. 67 individuals must be enrolled from 6 different healthcare facilities."

Answered by AI

Has the FDA sanctioned Active for medicinal use?

"Our team at Power assigned Active a score of 2 on the scale due to limited clinical data showing its safety. There is yet no evidence proving efficacy."

Answered by AI

Are there any enrollment opportunities for this research project at present?

"Indeed, the data available on clinicaltrials.gov indicates that this medical study is actively recruiting participants. Originally posted in July of 2022 and updated most recently in October, it seeks 67 patients from six sites for enrolment."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
What site did they apply to?
Hassman Research Institute
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

To help usher in medications for the future generations who also suffer from stuttering.
PatientReceived 2+ prior treatments
Ho provato numerosi farmaci. Sono parecchi anni che sto usando un paio di farmaci pero non stanno facendo piu nessun effetto. Sto continuando a prendere un antidepressivo solo per paura che mi ritorni una fase depressiva di cui ho sofferto un paio di volte.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A 10-week Efficacy Study of NOE-105 in Childhood Onset Fluency Disorder (Orpheus)
2022. "A 10-week Efficacy Study of NOE-105 in Childhood Onset Fluency Disorder (Orpheus)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05583955.
~27 spots leftby Apr 2025
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