ACTIVE_NOT_RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-09-10

Study Completion:2026-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06315751

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Principal Investigator

Clinical Director, MD

STUDY_DIRECTOR

Noema Pharma AG

Study Locations (Sites)

Noema TTS-201 Site #81

Sun City, Arizona, 85351

United States

Noema TTS-201 Site #95

Bellflower, California, 90706

United States

Noema TTS-201 Site #75

Glendale, California, 91203

United States

Noema TTS-201 Site #59

San Rafael, California, 94903

United States

Noema TTS-201 Site #21

Walnut Creek, California, 94596

United States

Noema TTS-201 Site #54

Gulf Breeze, Florida, 32561

United States

Noema TTS-201 Site #05

Hialeah, Florida, 33013

United States

Noema TTS-201 Site #97

Jensen Beach, Florida, 34957

United States

Noema TTS-201 Site #71

Largo, Florida, 33777

United States

Noema TTS-201 Site #44

Maitland, Florida, 32751

United States

Noema TTS-201 Site # 74

Miami, Florida, 33136

United States

Noema TTS-201 Site #56

Miami Lakes, Florida, 33016

United States

Noema TTS-201 Site #61

Orlando, Florida, 32802

United States

Noema TTS-201 Site #79

Atlanta, Georgia, 30318

United States

Noema TTS-201 Site #87

Peachtree Corners, Georgia, 30071

United States

Noema TTS-201 Site #55

Boston, Massachusetts, 02114

United States

Noema TTS-201 Site #51

Ann Arbor, Michigan, 48105

United States

Noema TTS-201 Site #96

Saint Charles, Missouri, 63304

United States

Noema TTS-201 Site #93

Lincoln, Nebraska, 68526

United States

NOema TTS-201 Site #19

New York, New York, 10003

United States

Noema TTS-201 Site #03

Stony Brook, New York, 11794

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 #73

North Charleston, South Carolina, 29405

United States

Noema TTS-201 Site #98

Nashville, Tennessee, 37203

United States

Noema TTS-201 Site #42

Dallas, Texas, 75243

United States

Noema TTS-201 Site #22

Fort Worth, Texas, 76104

United States

Noema TTS-201 Site #94

San Antonio, Texas, 78249

United States

Noema TTS-201 Site #45

Orem, Utah, 84097

United States

Noema TTS-201 Site #18

Petersburg, Virginia, 23805

United States

Noema TTS-201 Site #50

Bellevue, Washington, 98007

United States

Collaborators and Investigators

Sponsor: Noema Pharma AG

Clinical Director, MD, STUDY_DIRECTOR, Noema Pharma AG

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-10

Study Completion Date2026-04

Study Record Updates

Study Start Date2024-09-10

Study Completion Date2026-04

Terms related to this study

Keywords Provided by Researchers

NOE-105

Additional Relevant MeSH Terms

Tourette Syndrome