What is the mechanism of action of this treatment?

Stuttering, or childhood onset fluency disorder, is often treated with a combination of speech therapy and pharmacological interventions. Traditional pharmacological treatments, such as antipsychotics, work by altering neurotransmitter levels in the brain to reduce symptoms but can cause significant side effects. NOE-105, a newer treatment under study, aims to improve speech fluency without these adverse effects. This is crucial for stuttering patients as it offers the potential for effective symptom management while minimizing the risk of side effects that can impact overall quality of life and adherence to treatment.

What side effects are associated with this type of intervention?

Common treatments for stuttering, particularly those involving antipsychotic medications, can lead to several side effects. These include extrapyramidal symptoms such as tremors and rigidity, weight gain, and metabolic issues like increased blood sugar and cholesterol levels. The trial NOE-105 aims to improve speech fluency without these antipsychotic-induced side effects, offering a potentially safer alternative for managing childhood onset fluency disorder.

What prior FDA approvals exist?

There is limited information on FDA-approved treatments specifically for stuttering. However, the trial of NOE-105 aims to improve speech fluency without the antipsychotic-induced side effects commonly associated with other treatments. This suggests that previous treatments may have included antipsychotic medications, which can have significant side effects. NOE-105 represents a novel approach by potentially offering benefits in speech fluency without these adverse effects.

What other types of research exist?

Currently, there are no specific alternatives to NOE-105 mentioned in the provided context for treating stuttering. However, treatments like risperidone have shown efficacy in related conditions such as disruptive behavior and cognitive-motor performance without significant side effects. Consulting with a healthcare provider for the latest research and personalized treatment options is recommended.

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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

Summary

This trial is testing NOE-105, a new drug, to see if it can help adult males with childhood onset fluency disorder speak more smoothly. The drug works by blocking a specific brain enzyme and aims to avoid the side effects of current 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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 71 days

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline to end point in severity subset of the MLGSSS

Change in clinical chemistry

Change in the hematological parameters

+3 more

Secondary study objectives

CGI-C rating at end point

Change from baseline to end point in SDS

Stuttering

+3 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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Stuttering, or childhood onset fluency disorder, is often treated with a combination of speech therapy and pharmacological interventions. Traditional pharmacological treatments, such as antipsychotics, work by altering neurotransmitter levels in the brain to reduce symptoms but can cause significant side effects. NOE-105, a newer treatment under study, aims to improve speech fluency without these adverse effects. This is crucial for stuttering patients as it offers the potential for effective symptom management while minimizing the risk of side effects that can impact overall quality of life and adherence to treatment.

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