Gemlapodect for Tourette Syndrome

(ALLEVIA2 Trial)

Recruiting at 65 trial locations

Overseen By Noema Pharma

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Noema Pharma AG

Must not be taking: Cannabinoids, CYP3A4 inhibitors

Disqualifiers: Severe anxiety, Bipolar, Schizophrenia, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 12 weeks

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, gemlapodect (also known as NOE-105), to determine its effectiveness in reducing tics in people with Tourette Syndrome (TS). Researchers aim to assess the safety and efficacy of gemlapodect for adults and, subsequently, adolescents with moderate to severe TS who require a new treatment option. Participants should have TS that significantly impacts their daily lives and must pause any current TS medications 14 days before starting the trial. The study involves taking capsules of either gemlapodect or a placebo (a pill with no active medicine) with gradually increasing doses. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

You will need to stop taking any medications used to treat Tourette Syndrome for at least 14 days before starting the trial. However, other psychotropic drugs, like stimulants, can be continued if they have been stable for at least 30 days before the trial and are expected to remain stable during the study.

Is there any evidence suggesting that gemlapodect is likely to be safe for humans?

Research shows that gemlapodect, also known as NOE-105, is being tested for safety in people with Tourette Syndrome (TS). Earlier studies found that gemlapodect was safe for adults with TS at a daily dose of 30 mg. Specifically, participants tolerated this amount well, with no serious side effects reported in those studies. As a new treatment, gemlapodect appears promising in reducing both vocal and motor tics, offering an exciting option for those seeking new therapies. Joining a clinical trial helps gather more information to ensure the treatment's safety and effectiveness. ^{1 2 3 4 5}

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

Unlike the standard treatments for Tourette Syndrome, which typically involve antipsychotic medications or behavioral therapies, Gemlapodect offers a new approach. Researchers are excited about Gemlapodect because it involves escalating doses of NOE-105 capsules, potentially providing a more targeted mechanism of action. This treatment aims to address the neurological pathways involved in Tourette Syndrome more directly, which could result in better management of symptoms with possibly fewer side effects.

What evidence suggests that gemlapodect might be an effective treatment for Tourette Syndrome?

Research has shown that gemlapodect, a new drug, may help reduce tics in people with Tourette Syndrome (TS). In studies, gemlapodect achieved its main goals, showing promise in decreasing both vocal and motor tics. This trial will test gemlapodect, which blocks a protein called PDE10A, believed to help control movement problems. Early results are positive, suggesting gemlapodect could be effective for people with TS. More research continues to confirm these findings. ^{1 2 3 6 7}

Who Is on the Research Team?

Clinical Director, MD

Principal Investigator

Noema Pharma AG

Are You a Good Fit for This Trial?

Adults and adolescents with moderate to severe Tourette Syndrome can join this trial. They must be able to consent, have a BMI of 18-35, and women must not be pregnant and use contraception. Medications for TS should be stopped for 14 days before the trial, but stable psychotropic drugs are allowed.

Inclusion Criteria

I can sign and understand the consent form.

Fluency in the language of the investigator, study staff, and the ICF/informed assent form

I am at least 18 years old, or I am 12 or older and part of a specific group that was studied first.

Exclusion Criteria

Neurostimulation/deep brain stimulation for TS

Medical conditions that could interfere with study procedures

Hypersensitivity to gemlapodect or its excipients

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Placebo Run-in

Participants undergo a 14-day placebo run-in to wash-out previous TS medication

2 weeks

1 visit (in-person)

Treatment

Participants receive gemlapodect or placebo once daily for 12 weeks

12 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Gemlapodect

Trial Overview The study tests Gemlapodect (NOE-105) against a placebo to see if it reduces tics in Tourette Syndrome patients. Adults will first participate; adolescents follow after initial results. Participants won't know if they're getting the real drug or a dummy pill.

How Is the Trial Designed?

Group I: Gemlapodect 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/NCT06315751

Efficacy and Safety of Gemlapodect (NOE-105) in Adults ... This study is designed to evaluate the efficacy and safety of gemlapodect (NOE-105) on reducing tics associated with Tourette Syndrome (TS) in adults with TS.

2. noemapharma.com noemapharma.com/2024/10/17/noema-pharma-announces-noe-105-gemlapodect-phase-2a-study-in-tourette-syndrome-met-primary-and-all-key-secondary-endpoints/

Noema Pharma Announces NOE-105 (gemlapodect ... Gemlapodect is a novel and first-in-class PDE10A inhibitor currently being studied to assess its potential to reduce vocal and motor tics in people with TS.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11274801/

A Novel PDE10A Inhibitor for Tourette Syndrome and Other ... The preclinical and clinical data presented here support the study of EM-221 in phase 2 trials of Tourette syndrome and other movement disorders.

4. clinicaltrials.eu clinicaltrials.eu/inn/gemlapodect/

Gemlapodect – Application in Therapy and Current Clinical ... A new clinical trial is underway to assess the effectiveness and safety of Gemlapodect (also known as NOE-105) in treating Tourette Syndrome. This study focuses ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06315751/efficacy-and-safety-of-gemlapodect-noe-105-in-adults-and-adolescents-with-tourette-syndrome

Efficacy and Safety of Gemlapodect (NOE-105) in Adults ... This study is designed to evaluate the efficacy and safety of gemlapodect (NOE-105) on reducing tics associated with Tourette Syndrome (TS) in adults with TS.

6. trialx.com trialx.com/clinical-trials/listings/317490/efficacy-and-safety-of-gemlapodect-noe-105-in-adults-and-adolescents-with-tourette-syndrome/

Efficacy and Safety of Gemlapodect (NOE-105) in Adults ... This study is designed to evaluate the efficacy and safety of gemlapodect (NOE-105) on reducing tics associated with Tourette Syndrome (TS) in ...

7. neurologylive.com neurologylive.com/view/pde10a-inhibitor-evaluated-tourette-syndrome-phase-2a-study

PDE10A Inhibitor Being Evaluated in Tourette Syndrome ... The investigational agent NOE-105 has previously been found safe for treating adults with Tourette syndrome at 30-mg daily doses.