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Gemlapodect for Tourette Syndrome (Allevia2 Trial)
Phase 2
Recruiting
Research Sponsored by Noema Pharma AG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Moderate to severe Tourette Syndrome as defined by DSM-5 diagnostic criteria and TS-CGI-S score ≥ 4
Discontinuation of all TS medications for at least 14 days prior to randomization, with stable psychotropic drugs for at least 30 days
Must not have
Strong inhibitors and inducers of CYP3A4
Use of prescribed or recreational cannabinoids during the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 85 days
Summary
This trial aims to test a new drug called gemlapodect (NOE-105) to see if it can help reduce tics in adults with Tourette Syndrome. Adolescents will be included
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Specific side effects aren't listed here, but generally, participants may experience reactions related to the medication or placebo such as nausea, headaches, dizziness or other symptoms that will be monitored throughout the study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My Tourette Syndrome is moderate to severe.
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I stopped taking Tourette syndrome medications 14 days ago and have been on stable mental health medications for 30 days.
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I am a woman who can have children, have had a recent period, and my pregnancy test is negative.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not taking any strong medication that affects liver enzymes.
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I use prescribed or recreational cannabinoids.
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I am currently institutionalized by court order.
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I have a severe diagnosis of anxiety, bipolar, schizophrenia, MDD, or Parkinson's.
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I have had a severe brain injury or stroke.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 85 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~85 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in tic severity score on the Revised Yale Global Tic Scoring Scale (YGTSS-R)
Secondary study objectives
Assessment of suicidality and suicidal ideation
Change in PUTS
Impact on patient functioning
+1 moreTrial Design
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
Find a Location
Who is running the clinical trial?
Noema Pharma AGLead Sponsor
5 Previous Clinical Trials
390 Total Patients Enrolled
Clinical Director, MDStudy DirectorNoema Pharma AG
2 Previous Clinical Trials
85 Total Patients Enrolled