Efficacy and Safety of Gemlapodect (NOE-105) in Adults and Adolescents With Tourette Syndrome

Purpose

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.

Condition

  • Tourette Syndrome

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Gemlapodect 		Escalating doses of NOE-105 capsules
  • Drug: 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.
    Other names:
    • NOE-105
Placebo Comparator
Placebo 		Escalating doses of matching placebo
  • Drug: Placebo
    Administered in the form of oral capsules with inert ingredients.

Recruiting Locations

NOE-TTS-201 Site #63
Dothan, Alabama 36303

Noema TTS-201 Site #59
San Rafael, California 94903

NOE-TTS-201 Site #71
Deland, Florida 32720

Noema TTS-201 Site #54
Gulf Breeze, Florida 32561

NOE-TTS-201 Site #44
Maitland, Florida 32751

NOE-TTS-201 Site #62
Miami, Florida 33175

Noema TTS-201 Site #84
Orange City, Florida 32763

NOE-TTS-201 Site #61
Orlando, Florida 32802

Noema TTS-201 Site #79
Atlanta, Georgia 30318

Noema TTS-201 Site #87
Peachtree Corners, Georgia 30071

Noema TTS-201 Site #55
Boston, Massachusetts 02114

NOE-TTS-201 Site #51
Ann Arbor, Michigan 48105

Noema TTS-201 Site #93
Lincoln, Nebraska 68526

NOE-TTS-201 Site #57
Charlotte, North Carolina 28211

Noema TTS-201 Site #58
Middleburg Heights, Ohio 44130

Noema TTS-201 Site #73
North Charleston, South Carolina 29405

Noema TTS-201 Site #42
Dallas, Texas 75243

More Details

NCT ID
NCT06315751
Status
Recruiting
Sponsor
Noema Pharma AG

Study Contact

Noema Pharma
please contact via email
clinicaltrials@noemapharma.com

Detailed Description

Gemlapodect is an investigational selective PDE10A inhibitor with a potential therapeutic effect for the treatment of tics associated with Tourette Syndrome (TS). This is a multi-center, double-blind, parallel-arm, placebo-controlled study in patients with TS. Following screening to confirm eligibility and to wash-out previous TS medication during a 14-day placebo run-in, patients will be randomized 1:1 on Day 1 to receive gemlapodect or placebo once daily for 12 weeks.

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Vanderbilt University Medical Center