NOE-105 for Stuttering

No longer recruiting at 17 trial locations

Overseen By Robert 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called NOE-105 to determine if it can improve speech fluency in people who stutter without causing the side effects often seen with other treatments. Participants will take escalating doses of NOE-105 capsules or a placebo, which is a look-alike pill with no active ingredient. The trial seeks participants who have stuttered since before age 8, have experienced moderate stuttering for 2 or more years, and are willing to stop other stuttering medications before starting the trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that NOE-105 is likely to be safe for humans?

Research has shown that NOE-105 is being tested for safety in individuals with childhood onset fluency disorder, also known as stuttering. The studies examine its ability to improve speech fluency without causing the side effects associated with other treatments. NOE-105 is designed to safely influence brain signals related to dopamine, a chemical affecting speech and movement.

In earlier studies with adults, NOE-105 was generally well-tolerated, with most participants not experiencing severe or unexpected side effects. Although specific details on side effects are not provided, the ongoing development of the treatment suggests a reasonable safety profile.

For those considering joining a trial, this information may offer reassurance about the treatment's safety. However, always consult a doctor to understand what it means personally. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for stuttering?

Unlike current treatments for stuttering, which often involve speech therapy or behavioral interventions, NOE-105 is a medication that targets the neurological aspects of the condition. Researchers are excited about NOE-105 because it introduces a potentially new mechanism of action by using escalating doses of an active ingredient specifically designed for stuttering. This approach could address the root causes of stuttering at a biological level, offering hope for more effective management of the condition.

What evidence suggests that NOE-105 might be an effective treatment for stuttering?

Research shows that NOE-105, which participants in this trial may receive, could be a promising treatment for stuttering, also known as childhood onset fluency disorder (COFD). It targets a specific enzyme in the brain, potentially improving speech flow. Earlier studies demonstrated that NOE-105 offers potential benefits without the side effects often seen with other treatments for similar conditions. These positive results have sparked further interest in its ability to help people who stutter. While more research continues, initial findings suggest that NOE-105 could be a helpful option for improving speech fluency in those with COFD. ^{1 2 3 5 6}

Who Is on the Research Team?

Gerald A Maguire, M.D.

Principal Investigator

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

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Active Experimental Treatment 1 Intervention

Escalating doses of NOE-105 capsules

Group II: Placebo Placebo Group 1 Intervention

Escalating doses of matching placebo

Who Is Running the Clinical Trial?

Noema Pharma AG

Lead Sponsor

Trials

6

Recruited

570+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05583955

NCT05583955 | A 10-week Efficacy Study of NOE-105 in ... NOE-105 is an investigational selective PDE10A inhibitor with a potential therapeutic effect for the treatment of COFD. In this study adult male patients ...

2. noemapharma.com noemapharma.com/2022/06/27/noema-pharma-announces-fda-investigational-new-drug-ind-authorization-for-orpheus-phase-2b-study-of-pde10a-inhibitor-gemlapodect-noe-105-in-childhood-onset-fluency-disorder/

Noema Pharma announces FDA Investigational New Drug ... Efficacy and safety study evaluating gemlapodect (NOE-105) in adults with Childhood Onset Fluency Disorder (also known as stuttering) ...

3. clinicaltrialsarena.com clinicaltrialsarena.com/features/pipeline-moves-stuttering-candidate-trial-completion/

Pipeline Moves: Progression prospects for stuttering ... Noema Pharma's NOE-105 saw its Phase Transition Success Rate (PTSR), increase after a Phase IIb trial was completed.

4. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT05583955/

Trial | NCT05583955 This study is designed to evaluate the effectiveness of NOE-105 on speech fluency without the known antipsychotic-induced side effects of commonly used ...

5. withpower.com withpower.com/trial/phase-2-childhood-onset-fluency-disorder-6-2022-a4a35

NOE-105 for Stuttering · Info for Participants 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.

6. noemapharma.com noemapharma.com/pipeline/

Our Pipeline Gemlapodect (NOE-105) is a potent, selective PDE10A inhibitor that has the potential to safely modulate dopamine D2 receptor signaling in people with Childhood ...