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

NCT06315751 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: NOE-TTS-201
• Study Type: interventional
• Target: 164
• Locations: 7 countries
• Sites: 46

Brief Summary

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.

Conditions

Tourette Syndrome

Keywords

NOE-105

Outcome Measures

Primary Outcomes (1)

• Change in tic severity score on the Revised Yale Global Tic Scoring Scale (YGTSS-R)

  YGTSS-R is a clinician rated score that evaluates number, frequency, intensity, complexity and interference of motor and phonic tics with a total score ranging from 0 to 50, with 50 being the most severe and 0 being no tics. Change in YGTSS-R total tic scores from baseline (randomization) to D85 for gemlapodect as compared to placebo. The primary estimand is the difference in means between gemlapodect and placebo for the change in the TTS of the YGTSS-R from baseline (randomization) to D85, in the target patient population of adult and adolescent patients with TS, regardless of whether or not dose reduction, suspension, or treatment discontinuation occurred due to events attributable to treatment, and regardless of change in background medication (dose and product) while under treatment, but in the absence of any new treatment started after discontinuation of investigational intervention

  85 days

Secondary Outcomes (4)

• Impact on patient functioning

  85 days

• Change in PUTS

  85 days

• Safety and Tolerability of gemlapodect

  85 days

• Assessment of suicidality and suicidal ideation

  85 days

Study Arms (2)

Gemlapodect

EXPERIMENTAL

Escalating doses of NOE-105 capsules

Drug: Gemlapodect

Placebo

PLACEBO COMPARATOR

Escalating doses of matching placebo

Drug: Placebo

Interventions

Gemlapodect DRUG

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.

Also known as: NOE-105

Gemlapodect

Placebo DRUG

Administered in the form of oral capsules with inert ingredients.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Moderate to severe Tourette Syndrome as defined by DSM-5 diagnostic criteria and TS-CGI-S ≥ 4.
• Treatment naive or previously treated patients in need of treatment alternative as per investigators judgement.
• 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.
• BMI within the range 18 to 35 kg/m2 (inclusive).
• 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.
• Capable of giving signed informed consent or consent from their legal representative.
• Fluency in the language of the investigator, study staff, and the ICF/informed assent form when applicable.

You may not qualify if:

• 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.
• 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.
• A history of severe traumatic brain injury or stroke.
• 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.
• 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.
• Known DSM-5 diagnosis of substance abuse or dependence.
• Active suicidal ideation or behavior.
• 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.
• Strong inhibitors and inducers of CYP3A4 are prohibited during the study.
• Neurostimulation/deep brain stimulation for TS.
• Participation in another clinical study with a study intervention administered in the last 30 days.
• Patients with a known hypersensitivity to gemlapodect or any of the excipients of the product
• Positive urine drug screen for cannabis, cocaine, or nonprescribed opiates.
• The person is an employee or family member of an employee of the Sponsor, Investigator, or study site personnel.
• 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.

Sponsors & Collaborators

• Noema Pharma AG: lead

Study Sites (46)

Noema TTS-201 Site #81

Sun City, Arizona, 85351, United States

Location

Noema TTS-201 Site #95

Bellflower, California, 90706, United States

Location

Noema TTS-201 Site #75

Glendale, California, 91203, United States

Location

Noema TTS-201 Site #59

San Rafael, California, 94903, United States

Location

Noema TTS-201 Site #21

Walnut Creek, California, 94596, United States

Location

Noema TTS-201 Site #54

Gulf Breeze, Florida, 32561, United States

Location

Noema TTS-201 Site #05

Hialeah, Florida, 33013, United States

Location

Noema TTS-201 Site #97

Jensen Beach, Florida, 34957, United States

Location

Noema TTS-201 Site #71

Largo, Florida, 33777, United States

Location

Noema TTS-201 Site #44

Maitland, Florida, 32751, United States

Location

Noema TTS-201 Site # 74

Miami, Florida, 33136, United States

Location

Noema TTS-201 Site #56

Miami Lakes, Florida, 33016, United States

Location

Noema TTS-201 Site #61

Orlando, Florida, 32802, United States

Location

Noema TTS-201 Site #79

Atlanta, Georgia, 30318, United States

Location

Noema TTS-201 Site #87

Peachtree Corners, Georgia, 30071, United States

Location

Noema TTS-201 Site #55

Boston, Massachusetts, 02114, United States

Location

Noema TTS-201 Site #51

Ann Arbor, Michigan, 48105, United States

Location

Noema TTS-201 Site #96

Saint Charles, Missouri, 63304, United States

Location

Noema TTS-201 Site #93

Lincoln, Nebraska, 68526, United States

Location

NOema TTS-201 Site #19

New York, New York, 10003, United States

Location

Noema TTS-201 Site #03

Stony Brook, New York, 11794, United States

Location

Noema TTS-201 Site #57

Charlotte, North Carolina, 28211, United States

Location

Noema TTS-201 Site #58

Middleburg Heights, Ohio, 44130, United States

Location

Noema TTS-201 Site #73

North Charleston, South Carolina, 29405, United States

Location

Noema TTS-201 Site #98

Nashville, Tennessee, 37203, United States

Location

Noema TTS-201 Site #42

Dallas, Texas, 75243, United States

Location

Noema TTS-201 Site #22

Fort Worth, Texas, 76104, United States

Location

Noema TTS-201 Site #94

San Antonio, Texas, 78249, United States

Location

Noema TTS-201 Site #45

Orem, Utah, 84097, United States

Location

Noema TTS-201 Site #18

Petersburg, Virginia, 23805, United States

Location

Noema TTS-201 Site #50

Bellevue, Washington, 98007, United States

Location

Noema TTS-201 Site #06

Ghent, 9000, Belgium

Location

Noema TTS-201 #07

Bron, 69677, France

Location

Noema TTS-201 Site #08

Poitiers, 86000, France

Location

Noema TTS-201 Site #35

Düsseldorf, 40225, Germany

Location

Noema TTS-201 Site #09

Hanover, 30625, Germany

Location

NOE-TTS-201 Site #25

Munich, 80336, Germany

Location

Noema TTS-201 Site #30

Budapest, 1013, Hungary

Location

Noema TTS-201 Site #13

Katowice, 40097, Poland

Location

Noema TTS-201 Site #14

Katowice, 40123, Poland

Location

Noema TTS-201 Site #26

Barcelona, 08041, Spain

Location

Noema TTS-201 Site #15

Burgos, 09006, Spain

Location

Noema TTS-201 Site #27

Madrid, 28922, Spain

Location

Noema TTS-201 Site #17

Oviedo, 33011, Spain

Location

Noema TTS-201 Site #16

Sant Cugat del Vallès, 08190, Spain

Location

NOE-TTS-201 Site #28

Seville, 41013, Spain

Location

Related Links

• Related Info

MeSH Terms

Conditions

Tourette Syndrome

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tic Disorders; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Clinical Director, MD

  Noema Pharma AG

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: March 18, 2024
• Study Start: September 10, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 9, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (6); HU (1); DE (3); BE (1); US (31); FR (2); PL (2)