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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-503545-67-00 | Other Identifier | EUCT |
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The primary objective of this study is to evaluate the long-term safety and tolerability of ecopipam tablets in children (greater than or equal to [>=] 6 and less than [<] 12 years of age), adolescents (>=12 and <18 years of age), and adults (>=18 years of age) with Tourette's Syndrome (TS).
This study is to evaluate the long-term safety and tolerability of ecopipam tablets in eligible participants. The eligible participants will be entered into a treatment period and start a 4-week titration phase to achieve a target steady-state dose of 1.8 milligram per kilogram per day (mg/kg/day) ecopipam (2 mg/kg/day dose of ecopipam HCl). During the 4-week titration phase ecopipam will be dispensed following weight bands before reaching their respective maintenance dose until end of the treatment. Safety assessment will be conducted at baseline visit and at all treatment visits (Months 1-12, 15, 18, 21 and 24). Safety follow up visits will be conducted 7 and 14 days and a follow up phone call will be conducted 30 days after the last dose of ecopipam.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ecopipam 1.8 mg/kg/day | Experimental | Ecopipam tablets will be administered orally (PO) once daily in the evening without regard to meals at concentrations 11.2, 22.4, 33.6, 44.8, 67.2 and 89.6 milligrams (mg) containing 12.5, 25, 37.5, 50, 75 and 100 mg ecopipam HCl, respectively in 4-week titration phase to achieve a target dose of 1.8 milligram per kilogram per day (mg/kg/day) ecopipam (2 mg/kg/day ecopipam HCl). Participants will be evaluated for safety at each baseline visit and at all treatment visits up to 24 months and at follow up visits at 7 and 14 days after last dose of ecopipam. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ecopipam | Drug | Selective dopamine D1 and D5 receptor antagonist |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) is defined as any untoward medical occurrence in a subject administered a study drug and which does not necessarily have a causal relationship with this treatment. A TEAE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered casually related to the product. | Baseline up to Month 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harmonex, Inc. | Dothan | Alabama | 36303 | United States | ||
| Arkansas Children's Hospital |
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| Little Rock |
| Arkansas |
| 72202 |
| United States |
| Advanced Research Center | Anaheim | California | 92805 | United States |
| CenExel CIT-IE | Bellflower | California | 90706 | United States |
| Cortica Site Network | Glendale | California | 91203 | United States |
| Cortica Site Network - San Rafael | San Rafael | California | 94903 | United States |
| Yale School of Medicine | New Haven | Connecticut | 06519 | United States |
| Childrens National Hospital | Washington D.C. | District of Columbia | 20010 | United States |
| NW FL Clinical Research Group, LLC | Gulf Breeze | Florida | 32561 | United States |
| Research in Miami Inc | Hialeah | Florida | 33013-3834 | United States |
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | United States |
| Florida International Research Center | Miami | Florida | 33173 | United States |
| Medical Research Group of Central Florida | Orange City | Florida | 32763 | United States |
| APG Research, LLC | Orlando | Florida | 32803 | United States |
| University of South Florida | St. Petersburg | Florida | 33701 | United States |
| Pediatric Epilepsy and Neurology Specialists | Tampa | Florida | 33609 | United States |
| Rare Disease Research, LLC | Atlanta | Georgia | 30329 | United States |
| Lurie Children Hospital of Chicago | Chicago | Illinois | 60611 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Josephson-Wallack-Munshower Neurology | Indianapolis | Indiana | 46256 | United States |
| University of Louisville Research Foundation Inc. | Louisville | Kentucky | 40202 | United States |
| Kennedy Krieger Institute | Baltimore | Maryland | 21205 | United States |
| Mass General Hospital | Boston | Massachusetts | 02114 | United States |
| Boston Childrens Hospital | Boston | Massachusetts | 02115 | United States |
| Umass Chan Medical School | Worcester | Massachusetts | 01655 | United States |
| Michigan Clinical research Institute PC | Ann Arbor | Michigan | 48105 | United States |
| Neurobahavioral Medicine Group | Bloomfield Hills | Michigan | 48302 | United States |
| St. Louis Children's Hospital | St Louis | Missouri | 63110 | United States |
| Alivation Research | Lincoln | Nebraska | 68526 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| OnSite Clinical Solutions LLC | Charlotte | North Carolina | 28211 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| National Childrens Hospital - The Ohio State University | Columbus | Ohio | 43205 | United States |
| North Star Medical Research, LLC | Middleburg Heights | Ohio | 44130 | United States |
| Providence Brain and Spine Institute | Portland | Oregon | 97225 | United States |
| Coastal Pediatric Research | Charleston | South Carolina | 29414 | United States |
| Access Clinical Trials, Inc. | Nashville | Tennessee | 37203-6502 | United States |
| Access Clinical Trials, Inc. | Nashville | Tennessee | 37203 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232-2551 | United States |
| UT Southwestern | Dallas | Texas | 75390 | United States |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| Road Runner Research, Ltd | San Antonio | Texas | 78249 | United States |
| Cedar Clinical Research | Draper | Utah | 84020 | United States |
| Core Clinical Research | Everett | Washington | 98201 | United States |
| Center Spectar-Plovdiv | Plovdiv | Bulgaria | 4004 | Bulgaria |
| ASMP-IP- d-r Kayryakova | Sofia | Sofia-Grad | 1360 | Bulgaria |
| Kalimat Medical Center_Sofia | Sofia | 1680 | Bulgaria |
| The Kids Clinic Inc | Ajax | Ontario | L1Z 0M1 | Canada |
| Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Gyermek-es Ifjusagpszicihatria | Szeged | Hungary | 6720 | Hungary |
| Bethesda Childrens Hospital(Magyarországi Református Egyház Bethesda Gyermekkórháza) | Budapest | 1146 | Hungary |
| Istituto Giannina Gaslini, Universita di Genova | Genova | GE | 16148 | Italy |
| Universita degli Studi di Napoli Federico II | Naples | Napoli | 80131 | Italy |
| Ospedale Pediatrico Bambino Ges | Roma | RM | 165 | Italy |
| Azienda Ospedaliero Universitaria " G. Rodolico - San Marco" | Catania | 95123 | Italy |
| IRCCS Istituto Neurologico Carlo Besta | Milan | 20133 | Italy |
| Neurologia Śląska Centrum Medyczne | Katowice | Poland | 40-689 | Poland |
| Gdanskie Centrum Zdrowia Sp z o.o. | Gdansk | Pomeranian Voivodeship | 80-542 | Poland |
| Clinical Research Center Sp. z o.o. MEDIC-R Sp.k. | Poznan | Wielkopolska | 61-731 | Poland |
| Wojewdzki Specjalistyczny Szpital Dziecicy im. sw. Ludwika w Krakowie | Krakow | Woj. Malopolskie | 31-503 | Poland |
| Centrum Medyczne Plejady | Krakow | 30-363 | Poland |
| Institute of Mental Health | Belgrade | Belgrad | 11120 | Serbia |
| Clinic of Neurology and Psychiatry for Children and Adolescents | Belgrade | Grad Beograd | 1100 | Serbia |
| Clinical Centre Nis Center of Mental Health | Niš | Serbia | 18000 | Serbia |
| Hospital General Universitario Gregorio Maranon | Madrid | Madrid | 28007 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | Madrid | 28041 | Spain |
| Hospital Universitario Central de Asturias | Oviedo | Principality of Asturias | 33011 | Spain |
| Hospital Universitario Virgen del Rocío | Seville | Sevilla | 41013 | Spain |
| ID | Term |
|---|---|
| D005879 | Tourette Syndrome |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D019636 | Neurodegenerative Diseases |
| D009069 | Movement Disorders |
| D013981 | Tic Disorders |
| D009422 | Nervous System Diseases |
| D002493 | Central Nervous System Diseases |
| D001927 | Brain Diseases |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| C058081 | ecopipam |
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