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Study on the Effects of Ecopipam Hydrochloride for Children and Adolescents with Tourette's Disorder

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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's Disorder, a condition characterized by repetitive movements or sounds that are difficult to control, known as tics. The trial will evaluate the safety and effectiveness of a medication called Ecopipam, which is taken in tablet form. Ecopipam is being tested in different doses: 11.2 mg, 22.4 mg, 33.6 mg, 44.8 mg, 67.2 mg, and 89.6 mg. The study also includes a comparison with a placebo to assess the medication's true effects.

The purpose of this study is to determine how well Ecopipam maintains its effectiveness in treating children and adolescents with Tourette's Disorder. Participants in the study will be randomly assigned to receive either Ecopipam or a placebo. The study will be conducted over a period of several weeks, during which participants will take the medication orally. The trial will monitor the time it takes for symptoms to return, known as a relapse, in those taking Ecopipam compared to those taking a placebo.

This trial involves children, adolescents, and adults with Tourette's Disorder. The study aims to provide valuable information on the long-term use of Ecopipam and its ability to help manage the symptoms of this disorder. Participants will be closely monitored throughout the study to ensure their safety and to gather data on the medication's effectiveness. The results of this trial could contribute to better treatment options for individuals living with Tourette's Disorder.

The research process

The trial runs in 7 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 will be conducted to confirm eligibility. This includes verifying age, weight, and the presence of Tourette's Disorder symptoms.

    Participants must have both motor and vocal tics that interfere with daily routines and meet specific criteria for Tourette's Disorder.

  2. Step 2

    Baseline evaluation

    A baseline evaluation will be performed to assess the severity of symptoms using a standardized scale. This helps in understanding the impact of the disorder on daily life.

    Participants will be required to have a minimum score on this scale to continue in the study.

  3. Step 3

    Medication administration

    Participants will be randomly assigned to receive either ecopipam tablets or a placebo. The dosage of ecopipam can vary, including 11.2 mg, 22.4 mg, 33.6 mg, 44.8 mg, 67.2 mg, or 89.6 mg, taken orally.

    The medication will be administered daily, and the specific dosage will be determined by the study protocol.

  4. Step 4

    Treatment period

    The treatment period will last for 12 weeks. During this time, participants will continue taking the assigned medication and attend regular check-ups to monitor progress and any side effects.

    Participants will be asked to report any changes in symptoms or overall health.

  5. Step 5

    Randomized withdrawal

    After the initial 12-week treatment period, participants will enter a randomized withdrawal phase. This means some participants will continue with the medication, while others will receive a placebo.

    The goal is to evaluate the maintenance of symptom control without the medication.

  6. Step 6

    Follow-up assessments

    Regular follow-up assessments will be conducted to track any changes in symptoms and overall health. These assessments help determine the long-term effects of the medication.

    Participants will be monitored for any signs of relapse or improvement.

  7. Step 7

    End of study

    At the end of the study, a final evaluation will be conducted to assess the overall impact of the treatment on Tourette's Disorder symptoms.

    Participants will receive guidance on next steps and any necessary follow-up care.

Who can join the trial?

8 criteria

  • Participants must be 6 years of age or older at the time of screening.
  • Participants must weigh at least 18 kg (39.6 lbs.).
  • Participants must have Tourette's Disorder based on specific diagnostic criteria.
  • Participants must have both motor and vocal tics that interfere with their normal routines.
  • Participants must have a minimum score of 20 on the YGTSS-TTS, a scale that measures tic severity, at both the screening and baseline visits.
  • Female participants who can become pregnant must agree to use a highly effective method of contraception during the study and for 30 days after stopping the study medication. This includes methods like hormonal contraception, intrauterine devices, or true sexual abstinence.
  • Female participants using hormonal contraception must also use a barrier method like a condom or diaphragm and should have been stable on their hormonal contraceptive for at least 4 weeks before screening.
  • For participants in the EU, they must have tried non-drug therapies without success before joining the study.

Who cannot join the trial?

8 criteria

  • Patients who do not have Tourette's Disorder cannot participate. Tourette's Disorder is a condition that causes people to make involuntary movements or sounds, called tics.
  • Children younger than 6 years old and older than 18 years old cannot participate.
  • Patients who are not able to follow the study instructions or procedures cannot participate.
  • Patients who have other medical conditions that might interfere with the study cannot participate.
  • Patients who are taking medications that might interfere with the study cannot participate.
  • Patients who have a history of not following medical advice or treatment plans cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently cannot participate.
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Investigated drugs

Ecopipam is a medication being studied for its potential to help people with Tourette's Disorder. Tourette's Disorder is a condition that causes people to have involuntary movements and sounds, known as tics. Ecopipam works by blocking certain signals in the brain that may be involved in causing these tics. The goal of this study is to see if Ecopipam can safely and effectively reduce the symptoms of Tourette's Disorder in children and adolescents over a longer period of time.

What is already known about the treatment

Ecopipam – Ecopipam is administered in tablet form and is taken orally. It is currently being studied in clinical trials to assess its safety and effectiveness in treating Tourette's Disorder in children, adolescents, and adults. The main therapeutic use of Ecopipam is to help manage the symptoms of Tourette's Disorder, which includes involuntary movements and vocalizations. At the molecular level, Ecopipam works by blocking certain receptors in the brain that are involved in the regulation of movement and behavior. It is classified pharmacologically as a dopamine receptor antagonist.

Investigated diseases

Tourette's Disorder – Tourette's Disorder is a neurological condition 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 disorder typically begins in childhood, with symptoms often appearing between the ages of 5 and 10. Tics can vary in frequency and intensity, sometimes becoming more noticeable during periods of stress or excitement. Over time, the type and severity of tics may change, with some individuals experiencing a reduction in symptoms as they age. The exact cause of Tourette's Disorder is not fully understood, but it is believed to involve a combination of genetic and environmental factors.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503494-38-00Protocol codeEBS-101-TD-301Estimated enrolment239 patientsSponsorEmalex Biosciences Inc.

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