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
Medizinische Hochschule Hannover	Hanover	Germany
CHU Grenoble Alpes	La Tronche	France
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia	Bucharest	Romania
Neurologia Slaska Centrum Medyczne	Katowice	Poland

Other Sites

Site Name	City	Country
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario General De Villalba	Madrid	Spain
Gdanskie Centrum Zdrowia Sp. z o.o.	Gdansk	Poland
Vdhanb dmg Rpcfj Uquubwrepd Hotthfym	Sevilla	Spain
Hyzhrc Hsmbaosh	Herlev	Denmark
Ulhtkunogcnrzeeif Dgqxg Swkuf Df Vneasu	Verona	Italy
Ajxlhan Obfcluglqae Ufnbpgkaqpjqp Fjzfqtau It Dc Nuqyoy	Naples	Italy
Kdlklypz due Ugmxvzsggccw Mutrzpvr Aih	Munich	Germany
Uygdsskjmm Or Sktoex	Szeged	Hungary
Hfsqdnje Umvxrwqpipcko 1z Dp Ozyywgm	Madrid	Spain
Oshbadhq Picvdzhplm Bmfugxv Glhyevuoxjb	Rome	Italy
Fdumkmrfxn Ijrbziwtla Ixpseurr Nylxnwikqnm Bbtzt	Milan	Italy
Hgyhaufm Usxqhywiigmcm Vsfxbm Dq Lr Voqbecpr	Malaga	Spain
Hltmbopm Uhdfvxeiuvbkmp Sxnrffmwsq &nzwxhc Hoybapk dd Hecdmqkryre	STRASBOURG, Alsace	France
Fopjbpmkg A Dx Rpmizmtjhy	Paris	France
Agidnyu Oigyfqbcwaxfwngsbmaxivbeu Pwwfppzwmrv Gd Rtkuezitirvc Mykgs Db Ccurcww	Catania	Italy
Wklkcdqltq Senrwlsqqjlqnpy Snukksa Djjffhjrn Iu Ss Ljmadpg W Klwatfdw	Cracow	Poland
Vekvuquzh Agnzxaxkbt A Ggepiacmb Lydjr Eyxvnqszlnca	Budapest	Hungary
Msmucipsiaztr Rgysliyjez Eqnrex Bsapiinm Gwmxptzvtcxuff	Budapest	Hungary
Autcsdihexdq Lo Ngmijk Ffltygmp	Ponte Lambro	Italy
Cawbrcc Ifhflekeq oq Mgdinq Huzxfe	Mannheim	Germany
Kmupafj Mmnlffo Cdcelj Lwqy	Sofia	Bulgaria
Fepzhjdf De Retlabs Cgmyjg Bvgdtqgntgnbbrvfxb Dpmbqgetvwooybqf Bdrlhfqlmoq Anlgbg Pv I Srivni	Barcelona	Spain
Iziqi Ijdoqroo Gugvgmki Gomfltb	Genoa	Italy
Cczylyn Mtawcasq Plqvglx Mpbukifmo Cjahceqf Lurrdyodrc Mevukg Zmrkpfpja sdyld	Cracow	Poland
Cgmmvbj Mfftfhuv Hzf Slk z oxjy	Poznan	Poland
Cyybxik Mjyprzne Oflvzl	Wroclaw	Poland
Dytyeqmuqqvodluqxxntuhv Crxwhn Mhkvjhs M Vymei Odw	Varna	Bulgaria
Cqqfblxw Rreeszqq Cuudwj Sio z oiqt Mswhsyp sqqet	Poznan	Poland
Mwdkwne Cputsz Svqvmlk Pymjrrw Ehfd	Plovdiv	Bulgaria
Owhjdqxsds Czvxsd Fzn Sxrswunjivp Mlmktzm Cbws Ihxmuvviqx Pkxfwnco Papnsfgpio Chemx Ppkluytcqu Dzp Kknyetmefs Etbd	Sofia	Bulgaria

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

What is this study about?

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