Study on the Long-Term Safety of Ecopipam Hydrochloride Tablets for Children, Adolescents, and Adults with Tourette’s Disorder

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What is this study about?

This clinical trial is focused on studying the long-term safety of a medication called ecopipam in individuals with Tourette’s Disorder. Tourette’s Disorder is a condition characterized by repetitive movements or unwanted sounds, known as tics, that are difficult to control. The study involves children, adolescents, and adults who have previously participated in related studies and are eligible to continue. The medication being tested, ecopipam, is taken in the form of tablets and is designed to help manage the symptoms of Tourette’s Disorder.

The purpose of this study is to evaluate how safe and tolerable ecopipam is when used over a long period. Participants will take ecopipam tablets orally, which means they will swallow the tablets. The study will monitor participants for any side effects or issues that may arise from taking the medication over time. The study does not involve any comparison with a placebo, and all participants will receive the actual medication.

Participants in this study will be observed for a period of up to 105 days. During this time, they will take ecopipam tablets at varying doses, depending on their specific needs and previous study participation. The study aims to ensure that ecopipam is safe for long-term use in managing the symptoms of Tourette’s Disorder, providing valuable information for future treatment options.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, the study team will review your medical history and confirm your eligibility to participate in the trial. This includes ensuring you have completed previous related studies if applicable.

You will be informed about the study procedures, and any questions you have will be addressed. You will also be asked to sign a consent form to confirm your willingness to participate.

2 medication administration

You will be given **Ecopipam** tablets to take orally. The dosage may vary, including options such as 11.2 mg, 22.4 mg, 33.6 mg, 44.8 mg, 67.2 mg, or 89.6 mg. The specific dosage and frequency will be determined by the study team based on your individual needs.

The medication is intended to be taken regularly as instructed by the study team. It is important to follow the dosage schedule provided to you.

3 regular follow-up visits

Throughout the study, you will have regular follow-up visits with the study team. These visits are designed to monitor your health and the effects of the medication.

During these visits, you may undergo various assessments and provide feedback on your experience with the medication. The study team will also check for any side effects or changes in your condition.

4 end of study procedures

At the end of the study, you will have a final visit with the study team. This visit will include a comprehensive evaluation of your health and a discussion about your experience during the trial.

You will be provided with information on any necessary follow-up care or additional steps to take after the study concludes.

Who Can Join the Study?

You must have participated in one of the following studies: EBS-101-TD-301, EBS-101-OL-001, or PSY-302A.
If you were in the EBS-101-TD-301 study, you must have completed all visits through Week 24 and the safety follow-up visits on Days 7 and 14, or met the criteria for relapse during the study and completed the Early Termination visit and follow-up visits on Days 7 and 14.
If you were in the EBS-101-OL-001 or PSY-302A studies, you must have completed the study.
The study doctor must believe that you benefited from the study medication, ecopipam, and that you would benefit from continuing in the study.
If you are a female who can become pregnant, you must agree to use a highly effective method of birth control during the study and for 30 days after stopping the study medication. This includes methods like birth control pills, patches, injections, implants, IUDs, or having a partner who has had a vasectomy.
If you are using hormonal birth control, you must also use a barrier method like a condom or diaphragm, and you should have been on your hormonal birth control for at least 4 weeks before starting the study.
If you are a sexually active male, you must use a highly effective method of birth control during the study and for at least 30 days after the last dose of the study medication.
If you are under 18 years old, both of your parents or legal guardian must sign a consent form, and you must sign an assent form, which is a document that shows you agree to participate.
If you are 18 years or older, you must sign a consent form to participate.
You must have been diagnosed with Tourette’s Disorder (TD) based on specific criteria from a medical manual.
You must have both motor tics (movements) and vocal tics (sounds) that interfere with your daily activities.

Who Cannot Join the Study?

Patients who have not participated in previous studies named EBS-101-TD-301, EBS-101-OL-001, or PSY-302A cannot join this study.
Patients who are not diagnosed with Tourette’s Disorder are excluded from the study.
Patients who are younger than 6 years old or older than 18 years old are not eligible.
Patients who are not able to take ecopipam tablets as part of the study treatment 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
CHU Grenoble Alpes	La Tronche	France
Neurologia Slaska Centrum Medyczne	Katowice	Poland

Other Sites

Site Name	City	Country
Hospital Universitario Central De Asturias	Oviedo	Spain
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
Outpatient Clinic For Specialized Medical Care Individual Practice Psychiatry Child Psychiatry Dr. Kayryakova EOOD	Sofia	Bulgaria
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
Hospital Universitario Virgen Macarena	Sevilla	Spain
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
Kalimat Medical Center Ltd.	Sofia	Bulgaria
Gdanskie Centrum Zdrowia Sp. z o.o.	Gdansk	Poland
Medical Center Spectar Plovdiv EOOD	Plovdiv	Bulgaria
Ospedale Pediatrico Bambino Gesu’	Rome	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
University Of Szeged	Szeged	Hungary
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Hjgebimp Uusizwyfwuals Felirvllp Ahbwwryo	Madrid	Spain
Hsdzbo Httkefxo	Herlev	Denmark
Ktwslhsi dsh Utgwxbvrlamj Mjcqbgzr Amv	Munich	Germany
Hfldytpv Utjlvfduagewwt Smrjnxkalz &uzacgl Hzueval di Hwuhzekfolh	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
Bulgaria	Recruiting	04.03.2024
Denmark	Not recruiting	04.03.2024
France	Recruiting	04.03.2024
Germany	Recruiting	04.03.2024
Hungary	Recruiting	04.03.2024
Italy	Recruiting	04.03.2024
Poland	Recruiting	04.03.2024
Spain	Recruiting	04.03.2024

Trial locations

Investigated drugs:

Ecopipam Hydrochloride

Ecopipam is a medication being studied for its long-term safety in 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 affecting certain chemicals in the brain that are thought to be involved in causing these tics. The goal of this study is to see if Ecopipam can be used safely over a long period of time in children, teenagers, and adults who have Tourette’s Disorder. Participants in this study have previously taken part in other related studies, and this trial aims to ensure that Ecopipam is safe and well-tolerated when used for an extended period.

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, such as 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:

2023-503545-67-00

Protocol code:

EBS-101-TD-391

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Long-Term Safety of Ecopipam Hydrochloride Tablets for Children, Adolescents, and Adults with Tourette’s Disorder

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?