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

2 1

What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Hochschule Hannover Hanover Germany
Centre Hospitalier Universitaire De Lille Lille France
Katholieke Universiteit te Leuven Leuven Belgium
Neurologia Slaska Centrum Medyczne Katowice Poland

Other Sites

Site Name City Country Status
Hospital Universitari General De Catalunya Sant Cugat Del Valles Spain
Centre Hospitalier Universitaire De Poitiers Poitiers France
Centrum Medyczne Hcp Sp. z o.o. Poznan Poland
Clinical Research Center Sp. z o.o. Medic-R sp.k. Poznan Poland
Wojewodzki Specjalistyczny Szpital Dzieciecy Im Sw Ludwika W Krakowie Cracow Poland
Gdanskie Centrum Zdrowia Sp. z o.o. Gdansk Poland
Med Polonia Sp. z o.o. Poznan Poland
Vadaskert Alapitvany A Gyermekek Lelki Egeszsegeert Budapest Hungary
Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaza Budapest Hungary
Virgen del Rocío University Hospital Sevilla Spain
Central Institute of Mental Health Mannheim Germany
Hospices Civils De Lyon Lyon France
Area De Salud De Burgos Y Soria Burgos Spain
Nous Astus Kft. Budapest Hungary
Cdvesgs Bueji Kifuskevxfe Pkzjvmol Sto z ozof Gdansk Poland
Bqvxst Gent Belgium
Mmddtpnytwji &tquvzsxnuuuanobiptv Sdx z oatm Katowice Poland
Siguwsbuwatynsc Pqhsprnr Lihgubsg Da Skmcjvbex Okuwizh Katowice Poland
Utotquoaomikrctsmjsra Duadppobbxw Aml Duesseldorf Germany
Kicemyhi dyp Uduhblckyjnn Mvcibxkz Afu Munich Germany
Hjsgwhhs De Lx Ssdlt Cxkt I Sdfb Pqy Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
21.03.2024
France France
Not recruiting
21.03.2024
Germany Germany
Not recruiting
21.03.2024
Hungary Hungary
Not recruiting
21.03.2024
Poland Poland
Not recruiting
21.03.2024
Spain Spain
Not recruiting
21.03.2024

Trial locations

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.

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 ID:
2023-505086-83-00
Protocol code:
NOE-TTS-201
NCT ID:
NCT06315751
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • Study on the Effects of Dronabinol and Palmidrol for Adults with Tourette Syndrome

    Recruiting

    2 1
    Investigated drugs:
    Germany
  • Study on Impulsivity Control in Adults with Tourette Syndrome Using [18F]-Altanserin and Aripiprazole

    Recruiting

    2 1 1 1
    France