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Compensation: Varies

Number of Visits: 1

Duration: 10 weeks

75 Participants Needed

NOE-105 for Stuttering

Recruiting at 17 trial locations

Overseen ByRobert Molpus

Age: 18 - 65

Sex: Male

Trial Phase: Phase 2

Sponsor: Noema Pharma AG

Must not be taking: Antipsychotics, Cannabinoids, Cocaine, Opiates

Disqualifiers: Neurological cause, Seizures, Brain injury, others

Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

You will need to stop taking any medications used to treat stuttering for at least 14 days before starting the study treatment. However, other psychotropic drugs (medications affecting mood, perception, or behavior) can be continued if they have been stable for at least 14 days before the study and remain stable during the study.

How does the drug NOE-105 for stuttering differ from other treatments?

The research does not provide specific information about NOE-105, but it highlights that no pharmacological treatment has been generally useful for all stuttering patients, and existing treatments like carbamazepine have shown subjective improvements without objective changes. This suggests that NOE-105 might offer a novel approach or mechanism compared to existing options.¹ ² ³ ⁴ ⁵

Research Team

Gerald A Maguire, M.D.

Principal Investigator

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

Eligibility Criteria

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.

Inclusion Criteria

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.

Patients who satisfy DSM-5 criteria for childhood onset fluency disorder and are suitable for pharmacotherapy.

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Exclusion Criteria

Involvement in the planning and/or conduct of the study (applies to both Noema staff and/or staff at the study site).

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.

Previous randomization in the present study.

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive escalating doses of NOE-105 or placebo for a total of 10 weeks

10 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

NOE-105
Placebo

Trial Overview 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.

Participant Groups

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