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Study on the Effects of Gemlapodect for Adults and Adolescents with Tourette Syndrome

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Tourette Syndrome, a condition characterized by repetitive movements or unwanted sounds (tics) that can't be easily controlled. The study will evaluate the effectiveness and safety of a new treatment called Gemlapodect, which is a novel PD10A inhibitor. This medication is taken orally in the form of hard capsules. The trial will also include a comparison with a placebo to assess the true effects of the treatment.

The purpose of the study is to determine how well Gemlapodect works in reducing the severity of tics in both adults and adolescents with Tourette Syndrome. Participants will be involved in the study for a period of twelve weeks. During this time, they will receive either the active medication or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo, to ensure unbiased results.

Throughout the study, various assessments will be conducted to monitor changes in tic severity and other related symptoms. These assessments will help researchers understand the impact of Gemlapodect on the participants' condition. The study aims to provide valuable insights into the potential benefits and safety of this new treatment for individuals living with Tourette Syndrome.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.

    Participants must discontinue all medications used to treat Tourette Syndrome for at least 14 days before randomization. Other psychotropic drugs are allowed if stable for at least 30 days prior to randomization.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either the study medication, gemlapodect, or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

  3. Step 3

    Medication administration

    Participants take the assigned medication orally in the form of hard capsules. The dosage and frequency are determined by the study protocol and are consistent throughout the 12-week study period.

  4. Step 4

    Regular assessments

    Throughout the study, regular assessments are conducted to monitor health and response to the medication. These include evaluations of tic severity, using the YGTSS-R scale, and other health indicators such as body weight, blood glucose, and lipids.

    Additional assessments include laboratory tests, ECGs, and vital signs monitoring. Participants are also evaluated for any adverse effects.

  5. Step 5

    Final evaluation

    At the end of the 12-week period, a final evaluation is conducted. This includes a comprehensive review of all collected data to assess the efficacy and safety of the treatment.

    The primary focus is on changes in tic severity scores from the start of the study to the end, comparing gemlapodect to the placebo.

Who can join the trial?

8 criteria

  • Patients must be at least 18 years old at the time of signing the informed consent form. Patients aged 12 to 17 can join if regional approval for adolescents is granted.
  • Patients should have moderate to severe **Tourette Syndrome (TS)**, as defined by specific diagnostic criteria.
  • Patients can be new to treatment or previously treated but in need of a different treatment option, as determined by the study doctor.
  • Patients must stop all medications used to treat TS for at least 14 days before starting the study. Other mental health medications, including stimulants, can be continued if they have been stable for at least 30 days before starting the study and are expected to remain stable during the study.
  • Patients should have a **Body Mass Index (BMI)** between 18 and 35 kg/m².
  • Women who can have children should only join after confirming a menstrual period and a negative pregnancy test. They must use birth control as required by local regulations. Young females who have not yet reached childbearing age can join with regular checks and must agree to monthly pregnancy tests.
  • Patients must be able to give signed informed consent, or consent must be obtained from their legal representative, agreeing to follow the study's requirements and restrictions.
  • Patients must be fluent in the language used by the study team and in the informed consent form, if applicable.

Who cannot join the trial?

4 criteria

  • Individuals who do not have Tourette Syndrome cannot participate. Tourette Syndrome is a condition that causes people to make involuntary movements or sounds, known as tics.
  • Participants must be within certain age ranges. If you are not within these age groups, you cannot join the study.
  • Both males and females can participate, but if you do not identify as either, you may not be eligible.
  • If you are part of a vulnerable population, which means you might need special protection or care, you may not be able to participate.
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Investigated drugs

Gemlapodect is a medication being studied for its potential to help reduce the severity of tics in people with Tourette Syndrome. This trial aims to evaluate how effective and safe Gemlapodect is for adults and adolescents who experience these involuntary movements and sounds. The study is designed to see if Gemlapodect can improve the tic severity score, which is a measure used to assess the impact of tics on a person's life.

What is already known about the treatment

Gemlapodect – This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating Tourette Syndrome. It is in the Phase IIb stage of clinical research, which means it is being tested for both efficacy and safety in a larger group of patients. The main therapeutic indication for Gemlapodect is the reduction of tic severity in individuals with Tourette Syndrome. At the molecular level, it works by modulating neurotransmitter activity in the brain, which helps to control the involuntary movements and vocalizations associated with the condition. Gemlapodect is classified pharmacologically as a central nervous system agent.

Investigated diseases

Tourette Syndrome – Tourette Syndrome is a neurological disorder characterized by repetitive, involuntary movements and vocalizations called tics. These tics can be motor, such as blinking or shrugging, or vocal, like grunting or repeating words. The severity and frequency of tics can vary over time, often worsening during stress or excitement. The condition typically begins in childhood, with symptoms usually appearing between ages 5 and 10. While the exact cause is unknown, it is believed to involve a combination of genetic and environmental factors. Tics often decrease in severity as individuals reach adulthood, although some may continue to experience them throughout their lives.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-505086-83-00Protocol codeNOE-TTS-201Estimated enrolment180 patientsSponsorNoema Pharma AG

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