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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Tourette Syndrome

In brief

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.

Key facts

Study ID

NCT06315751

Run by

Noema Pharma AG

People needed

164

Starts

2024-09-10

Expected to finish

2026-06-01

Last updated by the study team

2026-03-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.
• Previous randomization in the present study.
• The person is currently committed to an institution by virtue of an order issued either by the judicial or the administrative authorities

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.