180 Participants Needed

Gemlapodect for Tourette Syndrome

(ALLEVIA2 Trial)

Recruiting at 55 trial locations
NP
Overseen ByNoema Pharma
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

CD

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.
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
See 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
See 14 more

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?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: GemlapodectExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Noema Pharma AG

Lead Sponsor

Trials
6
Recruited
570+
Unbiased ResultsWe believe in providing patients with all the options.
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