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New pill aims to quiet tourette tics in landmark trial

NCT ID NCT06315751

Symptom relief Sponsor: Noema Pharma AG Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an experimental drug called gemlapodect to see if it can safely reduce tics in people with Tourette syndrome. About 164 adults and teens with moderate to severe tics will take the drug or a placebo for 12 weeks. The main goal is to measure changes in tic severity using a standard rating scale.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

164 people

The number who actually took part.

Started

Sep 2024

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Tourette syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Tourette syndrome

Contacts and locations

Locations

  • NOE-TTS-201 Site #25

    Munich, 80336, Germany

  • NOE-TTS-201 Site #28

    Seville, 41013, Spain

  • NOema TTS-201 Site #19

    New York, New York, 10003, United States

  • Noema TTS-201 #07

    Bron, 69677, France

  • Noema TTS-201 Site # 74

    Miami, Florida, 33136, United States

  • Noema TTS-201 Site #03

    Stony Brook, New York, 11794, United States

  • Noema TTS-201 Site #05

    Hialeah, Florida, 33013, United States

  • Noema TTS-201 Site #06

    Ghent, 9000, Belgium

  • Noema TTS-201 Site #08

    Poitiers, 86000, France

  • Noema TTS-201 Site #09

    Hanover, 30625, Germany

  • Noema TTS-201 Site #13

    Katowice, 40097, Poland

  • Noema TTS-201 Site #14

    Katowice, 40123, Poland

  • Noema TTS-201 Site #15

    Burgos, 09006, Spain

  • Noema TTS-201 Site #16

    Sant Cugat del Vallès, 08190, Spain

  • Noema TTS-201 Site #17

    Oviedo, 33011, Spain

  • Noema TTS-201 Site #18

    Petersburg, Virginia, 23805, United States

  • Noema TTS-201 Site #21

    Walnut Creek, California, 94596, United States

  • Noema TTS-201 Site #22

    Fort Worth, Texas, 76104, United States

  • Noema TTS-201 Site #26

    Barcelona, 08041, Spain

  • Noema TTS-201 Site #27

    Madrid, 28922, Spain

  • Noema TTS-201 Site #30

    Budapest, 1013, Hungary

  • Noema TTS-201 Site #35

    Düsseldorf, 40225, Germany

  • Noema TTS-201 Site #42

    Dallas, Texas, 75243, United States

  • Noema TTS-201 Site #44

    Maitland, Florida, 32751, United States

  • Noema TTS-201 Site #45

    Orem, Utah, 84097, United States

  • Noema TTS-201 Site #50

    Bellevue, Washington, 98007, United States

  • Noema TTS-201 Site #51

    Ann Arbor, Michigan, 48105, United States

  • Noema TTS-201 Site #54

    Gulf Breeze, Florida, 32561, United States

  • Noema TTS-201 Site #55

    Boston, Massachusetts, 02114, United States

  • Noema TTS-201 Site #56

    Miami Lakes, Florida, 33016, United States

  • Noema TTS-201 Site #57

    Charlotte, North Carolina, 28211, United States

  • Noema TTS-201 Site #58

    Middleburg Heights, Ohio, 44130, United States

  • Noema TTS-201 Site #59

    San Rafael, California, 94903, United States

  • Noema TTS-201 Site #61

    Orlando, Florida, 32802, United States

  • Noema TTS-201 Site #71

    Largo, Florida, 33777, United States

  • Noema TTS-201 Site #73

    North Charleston, South Carolina, 29405, United States

  • Noema TTS-201 Site #75

    Glendale, California, 91203, United States

  • Noema TTS-201 Site #79

    Atlanta, Georgia, 30318, United States

  • Noema TTS-201 Site #81

    Sun City, Arizona, 85351, United States

  • Noema TTS-201 Site #87

    Peachtree Corners, Georgia, 30071, United States

  • Noema TTS-201 Site #93

    Lincoln, Nebraska, 68526, United States

  • Noema TTS-201 Site #94

    San Antonio, Texas, 78249, United States

  • Noema TTS-201 Site #95

    Bellflower, California, 90706, United States

  • Noema TTS-201 Site #96

    Saint Charles, Missouri, 63304, United States

  • Noema TTS-201 Site #97

    Jensen Beach, Florida, 34957, United States

  • Noema TTS-201 Site #98

    Nashville, Tennessee, 37203, United States

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