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Evaluating gemlapodect for treating Tourette Syndrome in adults and adolescents

A Double-blind, Placebo-controlled, Phase 2b, Multi-center, Twelve-week Prospective Study to Evaluate the Efficacy and Safety of Gemlapodect in Adult and Adolescent Patients With Tourette Syndrome

Phase 2 Interventional Noema Pharma AG · NCT06315751

This study is testing a new medication called gemlapodect to see if it can help reduce tics in adults and adolescents with Tourette Syndrome.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment180 (estimated)
Ages18 Years and up
SexAll
SponsorNoema Pharma AG Industry-sponsored
Locations36 sites (Dothan, Alabama and 35 other locations)
Trial IDNCT06315751 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and safety of gemlapodect (NOE-105), a selective PDE10A inhibitor, in reducing tics associated with Tourette Syndrome (TS) in adults and adolescents. It is a multi-center, double-blind, parallel-arm, placebo-controlled trial where participants will be randomized to receive either gemlapodect or a placebo once daily for 12 weeks. Prior to randomization, patients will undergo a 14-day wash-out period from previous TS medications to ensure eligibility. The study will initially enroll adults, followed by adolescents after the adult cohort is completed.

Who should consider this trial

Good fit: Ideal candidates include adults and adolescents aged 12 years and older with moderate to severe Tourette Syndrome who are either treatment naive or seeking alternative treatments.

Not a fit: Patients with mild Tourette Syndrome or those who are not seeking treatment alternatives may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce tics in patients with Tourette Syndrome, improving their quality of life.

How similar studies have performed: While this approach is novel, other studies targeting Tourette Syndrome have shown varying degrees of success with different therapeutic agents.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Initially, patients aged 18 years onwards, at the time of signing the ICF form. Adolescents aged 12 years and older at the time of signing the ICF/informed assent form will be eligible for inclusion after completion of a sentinel cohort of adults.
2. Moderate to severe Tourette Syndrome as defined by DSM-5 diagnostic criteria and TS-CGI-S ≥ 4.
3. Treatment naive or previously treated patients in need of treatment alternative as per investigators judgement.
4. Patients must discontinue all medications used to treat TS for at least 14 days prior to randomization. Other psychotropic drugs, including stimulants, will be allowed provided they have been stable for at least 30 days prior to randomization and are expected to remain stable for the duration of the study.
5. BMI within the range 18 to 35 kg/m2 (inclusive).
6. Women of childbearing potential should only be included after a confirmed menstrual period and a negative highly sensitive urine or serum pregnancy test. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
7. Capable of giving signed informed consent or consent from their legal representative.
8. Fluency in the language of the investigator, study staff, and the ICF/informed assent form when applicable.

Exclusion Criteria:

1. Any medical condition which, in the opinion of the investigator, could interfere with study procedures including but not limited to functional tic-like disorder, secondary tic symptoms accompanied by late-onset tics, Huntington's chorea, malignant TS, neuroacanthocytosis, autism, and history of known intellectual disability that would affect patient's ability to comply with study procedures.
2. Current active diagnosis of severe anxiety, bipolar disorder, schizophrenia, major depressive disorder (MDD,), or Parkinson's disease. Patients with a history of MDD on selective serotonin reuptake inhibitors treatment stable for at least a month may participate in the study.
3. A history of severe traumatic brain injury or stroke.
4. Any unstable medical conditions, severe symptoms, or clinically significant abnormalities on screening test/examinations, including uncontrolled seizure disorders, which, in the investigator's judgment, will put them at a risk of major AE during this trial, or will interfere with safety and efficacy assessments.
5. Are undergoing active CBT (including but not limited to comprehensive behavioral intervention for tics, exposure and response prevention, relaxation training) during the last 28 days before the planned date of randomization and until the end of the trial. Patients willing to discontinue their CBT over this period are eligible to enroll in the study.
6. Known DSM-5 diagnosis of substance abuse or dependence.
7. Active suicidal ideation or behavior.
8. Use of prescribed or recreational cannabinoids during the study are prohibited. Prescribed cannabinoids include Epidiolex® (cannabidiol), Marinol® /Syndros® (dronabinol), and Cesamet® (nabilone). These medications will be discontinued during the Screening period. Study participants prescribed cannabinoids for seizure disorders are not eligible for study participation. Recreational cannabinoids, regardless of their form of intake, which include tetrahydrocannabinol and/or cannabidiol, are prohibited.
9. Strong inhibitors and inducers of CYP3A4 are prohibited during the study.
10. Neurostimulation/deep brain stimulation for TS.
11. Participation in another clinical study with a study intervention administered in the last 30 days.
12. Patients with a known hypersensitivity to gemlapodect or any of the excipients of the product
13. Positive urine drug screen for cannabis, cocaine, or nonprescribed opiates.
14. The person is an employee or family member of an employee of the Sponsor, Investigator, or study site personnel.
15. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
16. Previous randomization in the present study.
17. The person is currently committed to an institution by virtue of an order issued either by the judicial or the administrative authorities

Where this trial is running

Dothan, Alabama and 35 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Tourette SyndromeNOE-105
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.