Gemlapodect for Tourette Syndrome
(Allevia2 Trial)

Recruiting in Palo Alto (17 mi)

+31 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Noema Pharma AG

Must not be taking: Cannabinoids, CYP3A4 inhibitors

Disqualifiers: Severe anxiety, Bipolar, Schizophrenia, others

Prior Safety Data

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.

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

+5 more

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

+14 more

Trial 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)

Participant Groups

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.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: GemlapodectExperimental Treatment1 Intervention

Escalating doses of NOE-105 capsules

Group II: PlaceboPlacebo Group1 Intervention

Escalating doses of matching placebo