[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tourette-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tourette-disorder":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,37,76],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":4,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":25,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":33,"locationsCount":36},"100600134","expanded-access-program-for-treatment-with-ecopipam-for-tourettes-disorder-100600134",false,"NCT07093541","Expanded Access Program for Treatment With Ecopipam for Tourette's Disorder","An Open Label Expanded Access Program Intended to Provide Treatment With Ecopipam (EBS-101) to Children, Adolescents, and Adults in the U.S. With Tourette's Disorder","EBS-101-TD-392","Participants must fulfill all of the following inclusion criteria to be eligible for participation in the Study:\n\n1. Age 6 to 50 years old inclusive at the time of informed consent\u002Fassent.\n2. Participant must sign\u002Fdate the most current Informed Consent Form (ICF). For minor participants the LAR must\u002Fsign date the most current consent and the participant must sign\u002Fdate the most current age-appropriate assent.\n3. In the opinion of the principal investigator (PI), the participant or in the case of a minor their LAR is capable of understanding and complying with protocol and program requirements, oral drug administration and care instructions.\n4. Weight ≥18 kg (39.6 lbs.).\n5. In the opinion of the PI, the participant meets diagnostic criteria for Tourette's Syndrome (TS) per Diagnostic and Statistical manual for Mental Disorders - 5th Edition (DSM-5-TR diagnostic criteria for TD).\n6. The participant must have been treated with an FDA-approved treatment for TD (aripiprazole, haloperidol, or pimozide) or any other D2r antagonist (D2rA) and have experienced treatment failure, tolerability or safety issues as per LAR, participant or prescribing clinician or not have access to any of these approved medications.\n7. Females of child-bearing potential must have a negative urine pregnancy test at Screening.\n8. Females of child-bearing potential who are sexually active or become sexually active must be using double barrier method (condom and IUD, condom and spermicide, etc.) in addition to any oral contraceptive they may be using and agree to continue use of double barrier contraception for the duration of their participation in the study and for 30 days after their last dose of study drug. Females of non-childbearing potential are exempt from this criterion.\n\n   Non-Childbearing potential is defined by:\n   1. Post menopausal defined as \\>= 2 years amenorrheic, or,\n   2. Bilateral salpingo-oopherectomy, or\n   3. Hysterectomy, or\n   4. Pre-menarche\n9. Sexually active male participants must use a barrier method of contraception during the study and agree to continue the use of male contraception for at least 30 days after the last dose of study drug.\n10. Male participants must agree to not donate sperm and female participants not to donate eggs for at least 30 days after the last dose of study drug.\n\nDiagnosis and Main Criteria for Inclusion:\n\nInclusion Criteria\n\nParticipants must fulfill all of the following inclusion criteria to be eligible for participation in the Study:\n\n1. Age 6 to 50 years old inclusive at the time of informed consent\u002Fassent.\n2. Participant must sign\u002Fdate the most current Informed Consent Form (ICF). For minor participants the LAR must\u002Fsign date the most current consent and the participant must sign\u002Fdate the most current age-appropriate assent.\n3. In the opinion of the principal investigator (PI), the participant or in the case of a minor their LAR is capable of understanding and complying with protocol and program requirements, oral drug administration and care instructions.\n4. Weight ≥18 kg (39.6 lbs.).\n5. In the opinion of the PI, the participant meets diagnostic criteria for Tourette's Syndrome (TS) per Diagnostic and Statistical manual for Mental Disorders - 5th Edition (DSM-5-TR diagnostic criteria for TD).\n6. The participant must have been treated with an FDA-approved treatment for TD (aripiprazole, haloperidol, or pimozide) or any other D2r antagonist (D2rA) and have experienced treatment failure, tolerability or safety issues as per LAR, participant or prescribing clinician or not have access to any of these approved medications.\n7. Females of child-bearing potential must have a negative urine pregnancy test at Screening.\n8. Females of child-bearing potential who are sexually active or become sexually active must be using double barrier method (condom and IUD, condom and spermicide, etc.) in addition to any oral contraceptive they may be using and agree to continue use of double barrier contraception for the duration of their participation in the study and for 30 days after their last dose of study drug. Females of non-childbearing potential are exempt from this criterion.\n\n   Non-Childbearing potential is defined by:\n   1. Post menopausal defined as \\>= 2 years amenorrheic, or,\n   2. Bilateral salpingo-oopherectomy, or\n   3. Hysterectomy, or\n   4. Pre-menarche\n9. Sexually active male participants must use a barrier method of contraception during the study and agree to continue the use of male contraception for at least 30 days after the last dose of study drug.\n10. Male participants must agree to not donate sperm and female participants not to donate eggs for at least 30 days after the last dose of study drug.\n\nParticipants cannot be enrolled in the study if they meet any of the following criteria.\n\n1. Clinically meaningful abnormalities on laboratory tests at Screening as determined by the PI.\n2. Specific laboratory findings at enrollment\n\n   1. T. Bili \\>= 2.5 x ULN for age (Participants with a history of Gilbert's Disorder must have prior documentation of the disorder.)\n   2. ALT \\>= 2.5 x ULN for age\n   3. AST \\>= 2.5 x ULN for age\n   4. Positive urine drug screen for cocaine, amphetamine, benzodiazepines, barbiturates, phencyclidine (PCP), or opiates at Screening, except those receiving stable, prescribed treatment for attention deficit\u002Fhyperactivity disorder (ADHD) or a positive for benzodiazepine prescribed (either routine or as needed) for any anxiety disorder or anxiety associated with a depressive disorder\n   5. Severe renal impairment or end stage renal disease as defined by eGFR \\\u003C 60 ml\u002Fmin\u002F1.73m2\n3. Any of the following cardiovascular:\n\n   1. ECG with a QTcF \\> 450 for males or \\> 470 for females at screening.\n   2. A history or finding on the screening ECG of any significant arrhythmia in the opinion of the principal investigator\n   3. A known family history of QT prolongation syndrome with sudden death\n   4. Current or anticipated need for medications known to prolong the QT interval\n4. A lifetime history of any of the following disorders:\n\n   1. Myocardial Infarction\n   2. Cancer (excluding Basal Cell Carcinoma or Cervical Cancer in situ)\n   3. Seizure Disorder (except febrile seizure)\n   4. Neuroleptic Malignant Syndrome\n   5. Tardive Dyskinesia\n   6. Parkinson's Disorder\n   7. Dementia\n   8. Essential Tremor\n   9. Substance Use Disorders (as defined by DSM-5-TR) in the past 6 months prior to screening. (Excluding nicotine and\u002For caffeine)\n   10. Any general medical disorders OR psychiatric disorder that are not under good control in the opinion of the PI OR require treatment with any prohibited medication.\n5. All prescription or over-the-counter drug (e.g., St. Johns Wort) that are strong and moderate inhibitors or inducers of CYP3A4; drugs that are substrates of CYP2D6; or drugs that are substrates of MATE-2K transporters (e.g., metformin).\n6. At significant risk of attempting suicide in the opinion of the PI or any one of the following:\n\n   1. A history of a suicide attempt OR behavior in the past one year prior to Screening.\n   2. A lifetime history of 2 or more suicide attempts OR behaviors.\n   3. A history of non-suicidal self-injurious behavior in the past 2 years prior to Screening.\n   4. A history of suicide ideation OR thoughts in the past 6 months prior to Screening.\n7. Female participants who are currently pregnant or lactating or planning to become pregnant during the study.\n8. A history of hypersensitivity or allergic reaction to ecopipam or any inactive ingredient of the formulation.\n9. Participants unable to swallow tablets.\n10. Any participant who in the opinion of the PI or the Sponsor is not a suitable candidate for the program.","ALL","6 Years","50 Years","EXPANDED_ACCESS","The goal of this expanded access study is to learn about the long-term effects of Ecopipam in participants with Tourette's Disorder (TD). The main question it aims to answer is:\n\n* Is ecopipam safe and well-tolerated in participants equal and over the age of 6 to 50 with TD?\n* Assess quality of life measures and to provide access to ecopipam while NDA is being prepared and submitted for review for marketing approval\n\nEligible participants with TD will take ecopipam with guidance from their treating physician. In addition to the standard of care from the treating physician, treatment with ecopipam will continue until ecopipam becomes commercially available in the United States or the program is terminated.\n\nWhile in the EAP program, participants will be asked regarding how safe and tolerable ecopipam is to the participant. Several questionnaires will be collected regarding participants experiences while taking ecopipam during monthly visits for the first year and every three months thereafter until the conclusion of the study.",[23,24],"Tourettes Disorder","Tourette Disorder",[26,27],"Tourettes Syndrome","Ecopipam Tourette Disorder","AVAILABLE","2026-05-14",{"date":31,"type":32},"2026-05-18","ACTUAL",{"name":34,"class":35},"Emalex Biosciences Inc.","INDUSTRY",26,{"id":38,"slug":39,"hasResults":11,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":4,"eligibilityCriteria":43,"healthyVolunteers":11,"sex":17,"minAge":44,"maxAge":45,"enrollmentInfo":46,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":57,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100579532","investigating-changes-in-premonitory-urges-during-habit-reversal-training-for-tics-100579532","NCT06825520","Investigating Changes in Premonitory Urges During Habit Reversal Training for Tics","Investigating Changes in Premonitory Urges During Habit Reversal Training","Inclusion Criteria:\n\nParticipants who meet criteria for a DSM-5-TR diagnosis of a TD will be recruited to participate in this study. Participants will be eligible for the study if they\n\n1. present with at least three motor and\u002For vocal tics and are interested in receiving treatment,\n2. report experiencing a PU for each of their target tics with a minimum rating of a 4\u002F8 on a subjective rating (i.e., the Urge Thermometer; Silverman \\& Albano, 1996) for each tic,\n3. the targeted tics occur, on average, at least once per minute during a 10-minute direct observation,\n4. are between the ages of 8 and 17\n5. the patient has no planned changes in medication initiation or dosage during their study participation period.\n\nExclusion Criteria:\n\n1. the presence of any comorbid conditions that are considered a primary treatment concern and\u002For could interfere with study participation or treatment (i.e., unmanaged ADHD, OCD, anxiety),\n2. have previously engaged in CBIT or HRT for more than 2 sessions,\n3. a Yale Global Tic Severity Score of 40+ (or 20+ if they present with a primary motor or vocal tic disorder),\n4. suspected (based on clinical presentation) that the tics are better attributed to functional neurological symptom disorder per DSM-5-TR criteria (APA, 2022).","8 Years","17 Years",{"count":47,"type":48},6,"ESTIMATED","INTERVENTIONAL",[51],"NA","The primary aim of this study is to learn more about premonitory urges (PU) when using Habit Reversal Training (HRT) to treat tics.\n\nThe main focus of this study is to investigate if and when PU change during tic treatment sessions and between tic treatment sessions.\n\nParticipants will:\n\n* Attend 5 study visits (approximately 1 to 1.5 hours each) for an intake, habit reversal training for 3 separate tics, and a post assessment\n* Attend 5 practice sessions (approximately 30 minutes each) over a week for 3 weeks (total 15 practice sessions)\n* Study visits and practice sessions will take place in person and online via secure videoconference",[54,24,55,56],"Tics","Tourette Syndrome in Children","Tourette Syndrome in Adolescence",[58,59,60,61,62,63],"habit reversal training","tics","tourette","tourette's disorder","Tourette syndrome","treatment for tics","RECRUITING","2025-05-21",{"date":67,"type":32},"2025-05-28",{"date":69,"type":32},"2025-02-11",{"date":71,"type":48},"2026-05",{"name":73,"class":74},"University of Utah","OTHER",1,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":49,"phases":88,"briefSummary":90,"conditions":91,"keywords":92,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":106},"100511690","phase-2-serotonin-control-of-impulsivity-in-tourette-disorder-100511690","NCT05942716","Serotonin Control of Impulsivity in Tourette Disorder","Involvement of the Serotonergic System in the Control of Impulsivity in Tourette Disorder.","ARITEP","* Inclusion Criteria \\* :\n\n  * Male or Female\n  * Diagnosed with a Tourette Disorder following the DSM-5\n  * Age between 18-65 years\n  * Member of a social security scheme in France\n  * Freely-given informed consent to participate to this study (written form)\n  * With a current treatment by aripiprazole already scheduled\n  * With Tics compatible with TEP\u002FfMRI exams\n  * Having (for women only) effective contraception throughout participation in the study.\n\nExclusion Criteria \\* :\n\n* Male or Female\n* A serious not controlled psychiatric comorbidity\n* A serious, evolving or debilitating pathology with a potential influence on the study\n* Drug-taking with serotonergic effects (e.g., amphetamine, cocaine, MDMA, SSRIs, mianserin)\n* Contraindication for fMRI and PET (e.g., pacemaker, ferromagnetic implant, claustrophobia)\n* Women breastfeeding\n* Protected or restricted person (administratively or in judicial terms)\n* Participants to another study with radiations or radiotracers since less of one year, participants to a concomitant study\n* Do not speak french","18 Years","65 Years",{"count":87,"type":48},25,[89],"PHASE2","Tourette disorder (TD) is a neurodevelopmental disorder characterized by motor and vocal tics. It is often associated with multiple psychiatric comorbidities involving a high degree of impulsivity such as obsessive-compulsive disorders (OCD), attention-deficit hyperactivity disorders (ADHD), and intermittent explosive disorders (IED). Although a substantial body of clinical studies have emphasized the role of the dopamine system in motor symptoms, little is known about how the serotonergic (5-HT) system modulate both cognitive and affective abilities in TD. Several lines of evidence suggest that different 5-HT receptor subtypes may constitute a crucial factor in the development and maintenance of different symptoms. Because abnormal 5-HT2A receptor bindings have been reported in patients with TD and aripiprazole (drug of first choice) is a 5-HT2A antagonist, we hypothesize that 5-HT2A receptors may play an important role in regulating psychiatric symptoms in TD such as those characterized by impulsive behaviors. To investigate the involvement of 5-HT2A receptors in TD, we propose to perform a multimodal imaging study with 20 adult patients (ON and OFF treatment). Neuroimaging data will be collected with a hybrid system that simultaneously combines the positron emission tomography (PET) and the functional magnetic resonance imaging (fMRI). A highly selective PET radiotracer (\\[18F\\]-altanserin) will map 5-HT2A receptor bindings in the whole brain, while fMRI will provide detail information regarding the altered brain activities.",[24],[93,94,95,96],"Tourette","Serotonin","Impulsivity","Neuroimaging","2024-12-02",{"date":99,"type":32},"2024-12-04",{"date":101,"type":32},"2024-09-24",{"date":103,"type":48},"2028-09-24",{"name":105,"class":74},"Hospices Civils de Lyon",2]