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

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What is this study about?

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.

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 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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Medizinische Hochschule Hannover	Hanover	Germany
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia	Bucharest	Romania
CHU Grenoble Alpes	La Tronche	France
Neurologia Slaska Centrum Medyczne	Katowice	Poland

Other Sites

Site Name	City	Country
Kalimat Medical Center Ltd.	Sofia	Bulgaria
Centrum Medyczne Hcp Sp. z o.o.	Poznan	Poland
Centrum Medyczne Oporow	Wroclaw	Poland
Clinical Research Center Sp. z o.o. Medic-R sp.k.	Poznan	Poland
Associazione La Nostra Famiglia	Ponte Lambro	Italy
Vadaskert Alapitvany A Gyermekek Lelki Egeszsegeert	Budapest	Hungary
Fondation A De Rothschild	Paris	France
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Wojewodzki Specjalistyczny Szpital Dzieciecy Im Sw Ludwika W Krakowie	Cracow	Poland
Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaza	Budapest	Hungary
Virgen del Rocío University Hospital	Sevilla	Spain
Central Institute of Mental Health	Mannheim	Germany
Universita’ Degli Studi Di Verona	Verona	Italy
Hospital Universitario General De Villalba	Madrid	Spain
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
IRCCS Istituto Giannina Gaslini	Genoa	Italy
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.	Cracow	Poland
Diagnostics-Consultancy Center Mladost M Varna OOD	Varna	Bulgaria
Gdanskie Centrum Zdrowia Sp. z o.o.	Gdansk	Poland
Medical Center Spectar Plovdiv EOOD	Plovdiv	Bulgaria
Ospedale Pediatrico Bambino Gesu’	Rome	Italy
Outpatient Clinic For Specialized Medical Care Individual Practice Psychiatry Child Psychiatry Dr. Kayryakova EOOD	Sofia	Bulgaria
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
University Of Szeged	Szeged	Hungary
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Hzplkq Hianwziq	Herlev	Denmark
Kovbxtxc dqw Urmjjgzdtuse Melrjknv Avx	Munich	Germany
Hebzngkd Ukseqnzfvncpoa Snigrbhqck &rluchs Hrxqmrx da Hjejuanuzwc	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	19.06.2023
Denmark	Not recruiting	19.06.2023
France	Not recruiting	19.06.2023
Germany	Not recruiting	19.06.2023
Hungary	Not recruiting	19.06.2023
Italy	Not recruiting	19.06.2023
Poland	Not recruiting	19.06.2023
Romania	Not recruiting	19.06.2023
Spain	Not recruiting	19.06.2023

Trial locations

Investigated drugs:

Ecopipam Hydrochloride

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.

Investigated diseases:

Tourette's disorder

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 ID:

2023-503494-38-00

Protocol code:

EBS-101-TD-301

NCT ID:

NCT05615220

Trial Phase:

Therapeutic confirmatory (Phase III)

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

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