Efficacy and Safety of Gemlapodect (NOE-105) in Adults and Adolescents With Tourette Syndrome
NCT ID: NCT06315751
Last Updated: 2025-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
164 participants
INTERVENTIONAL
2024-09-10
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Gemlapodect
Escalating doses of NOE-105 capsules
Gemlapodect
Gemlapodect is an investigational selective PDE10A inhibitor with a potential therapeutic effect for the treatment of tics associated with TS. Administered in the form of oral capsules.
Placebo
Escalating doses of matching placebo
Placebo
Administered in the form of oral capsules with inert ingredients.
Interventions
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Gemlapodect
Gemlapodect is an investigational selective PDE10A inhibitor with a potential therapeutic effect for the treatment of tics associated with TS. Administered in the form of oral capsules.
Placebo
Administered in the form of oral capsules with inert ingredients.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Noema Pharma AG
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Director, MD
Role: STUDY_DIRECTOR
Noema Pharma AG
Locations
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Noema TTS-201 Site #81
Sun City, Arizona, United States
Noema TTS-201 Site #95
Bellflower, California, United States
Noema TTS-201 Site #75
Glendale, California, United States
Noema TTS-201 Site #59
San Rafael, California, United States
Noema TTS-201 Site #21
Walnut Creek, California, United States
Noema TTS-201 Site #54
Gulf Breeze, Florida, United States
Noema TTS-201 Site #05
Hialeah, Florida, United States
Noema TTS-201 Site #97
Jensen Beach, Florida, United States
Noema TTS-201 Site #71
Largo, Florida, United States
Noema TTS-201 Site #44
Maitland, Florida, United States
Noema TTS-201 Site # 74
Miami, Florida, United States
Noema TTS-201 Site #56
Miami Lakes, Florida, United States
Noema TTS-201 Site #61
Orlando, Florida, United States
Noema TTS-201 Site #79
Atlanta, Georgia, United States
Noema TTS-201 Site #87
Peachtree Corners, Georgia, United States
Noema TTS-201 Site #55
Boston, Massachusetts, United States
Noema TTS-201 Site #51
Ann Arbor, Michigan, United States
Noema TTS-201 Site #96
Saint Charles, Missouri, United States
Noema TTS-201 Site #93
Lincoln, Nebraska, United States
NOema TTS-201 Site #19
New York, New York, United States
Noema TTS-201 Site #03
Stony Brook, New York, United States
Noema TTS-201 Site #57
Charlotte, North Carolina, United States
Noema TTS-201 Site #58
Middleburg Heights, Ohio, United States
Noema TTS-201 Site #73
North Charleston, South Carolina, United States
Noema TTS-201 Site #98
Nashville, Tennessee, United States
Noema TTS-201 Site #42
Dallas, Texas, United States
Noema TTS-201 Site #22
Fort Worth, Texas, United States
Noema TTS-201 Site #94
San Antonio, Texas, United States
Noema TTS-201 Site #45
Orem, Utah, United States
Noema TTS-201 Site #18
Petersburg, Virginia, United States
Noema TTS-201 Site #50
Bellevue, Washington, United States
Noema TTS-201 Site #06
Ghent, , Belgium
Noema TTS-201 #07
Bron, , France
Noema TTS-201 Site #08
Poitiers, , France
Noema TTS-201 Site #35
Düsseldorf, , Germany
Noema TTS-201 Site #09
Hanover, , Germany
NOE-TTS-201 Site #25
Munich, , Germany
Noema TTS-201 Site #30
Budapest, , Hungary
Noema TTS-201 Site #13
Katowice, , Poland
Noema TTS-201 Site #14
Katowice, , Poland
Noema TTS-201 Site #26
Barcelona, , Spain
Noema TTS-201 Site #15
Burgos, , Spain
Noema TTS-201 Site #27
Madrid, , Spain
Noema TTS-201 Site #17
Oviedo, , Spain
Noema TTS-201 Site #16
Sant Cugat del Vallès, , Spain
NOE-TTS-201 Site #28
Seville, , Spain
Countries
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Related Links
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Related Info
Other Identifiers
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NOE-TTS-201
Identifier Type: -
Identifier Source: org_study_id
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