Gemlapodect for Tourette Syndrome

(ALLEVIA2 Trial)

Recruiting at 32 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

Trial Summary

What is the purpose of this trial?

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. Adolescents will be enrolled after a sentinel cohort of adults is complete.

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.

Research Team

Clinical Director, MD

Principal Investigator

Noema Pharma AG

Eligibility Criteria

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.

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

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

Exclusion Criteria

I am not taking any strong medication that affects liver enzymes.

Medical conditions that could interfere with study procedures

Hypersensitivity to gemlapodect or its excipients

Timeline

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)

Treatment Details

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.

Participant Groups

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+