[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100449008":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":95,"collaborators":25,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":25,"eligibilityCriteria":103,"healthyVolunteers":99,"sex":104,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":25,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":25,"overallStatus":116,"whyStopped":25,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Neurothera Labs Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SCI-110","EXPERIMENTAL","Cannabinoid-based medication consisting of Dronabinol and PEA",[13],"Drug: SCI-110",{"label":15,"type":16,"description":17,"interventionNames":18},"Dronabinol","PLACEBO_COMPARATOR","Placebo matched in taste, odour and appearance to SCI-110",[19],"Other: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","SCI-110 - a softgel capsule containing Dronabinol and Palmitoylethanolamide (PEA) in the following doses: 2.5mg Dronabinol+400mg PEA, 5mg Dronabinol+400mg PEA and 10mg Dronabinol+400mg. Maximum dose 20mg Dronabinol and 800mg PEA a day.",[9],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"OTHER","Placebo","Pill that matches in taste, odour and appearance to SCI-110 active pills",[15],[32],{"name":33,"affiliation":34,"role":35},"Kirsten R Müller-Vahl, PhD. MD","Hannover Medical School","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":25,"email":41},"Adi Zuloff-Shani, PhD","CONTACT","972-3-7175777","adi@scisparc.com",[43,64,79],{"facility":44,"status":25,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Yale Child Study Center - NIHB 205","New Haven","Connecticut","06519","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-72.92816,41.30815,{"lat":54,"lon":53},[57,61],{"name":58,"role":39,"phone":59,"phoneExt":25,"email":60},"Michael Bloch, MD, MS","203-745-9921","michael.bloch@yale.edu",{"name":62,"role":39,"phone":59,"phoneExt":25,"email":63},"Angeli Landeros-Weisenberger, MD","angeli.landeros@yale.edu",{"facility":65,"status":25,"city":66,"state":25,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Medizinische Hochschule Hannover","Hanover","30625","Germany","DE",{"type":51,"coordinates":71},[72,73],9.73322,52.37052,{"lat":73,"lon":72},[76],{"name":33,"role":39,"phone":77,"phoneExt":25,"email":78},"+49 511 532 3551","mueller-vahl.kirsten@mh-hannover.de",{"facility":80,"status":25,"city":81,"state":25,"zip":82,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Neurological Institute, Tel Aviv Sourasky Medical Center","Tel Aviv","64239","Israel","IL",{"type":51,"coordinates":86},[87,88],34.78057,32.08088,{"lat":88,"lon":87},[91],{"name":92,"role":39,"phone":93,"phoneExt":25,"email":94},"Tanya Gurevich, PhD. MD","972 3 6974912","tanyag@tlvmc.gov.il",{"type":96,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100449008","phase-2-sci-110-in-the-treatment-of-tourette-syndrome-100449008",false,"NCT05126888","SCI-110 in the Treatment of Tourette Syndrome","A Randomized, Double-Blind, Placebo Controlled, Cross-Over Study to Evaluate the Efficacy, Safety and Tolerability of Daily Oral SCI-110 in Treating Adults With Tourette Syndrome.","Inclusion Criteria:\n\n1. Tourette syndrome according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5)\n2. Male and female subjects with an age between ≥18 and ≤65 years\n3. Total tic score (TTS) of the revised Yale Global Tic Severity Scale (YGTSS-R) \\>14\n4. Clinical Global Impression-Severity Score (CGI-S) ≥4\n5. Medication (and stimulation parameters for deep brain stimulation) for tics and comorbidities must be on a stable dose for at least 6 weeks before entering the study and subject must consent to maintain the stable dose during the study\n6. Signed written informed consent and willingness to comply with treatment and follow-up procedures\n7. Subjects capable of understanding the investigational nature, potential risks and benefits of the clinical study\n8. Women of child-bearing potential must have a negative pregnancy test (e.g., urine human chorionic gonadotropin \\[hCG\\]) before first treatment with study medication. They must practice a highly effective, reliable and medically approved contraceptive regimen during the study (e.g., theoretical failure rate less than 1% per year as when used consistently and correctly), which include oral or parenteral or implanted hormonal contraception, vaginal ring releasing hormonal contraception (e.g., Nuvaring), intrauterine device or intrauterine system. Women without childbearing potential may enter this study. Women without childbearing potential defined as follows:\n\n   * at least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral oophorectomy or\n   * hysterectomy or uterine agenesis or\n   * ≥ 50 years and in postmenopausal state ≥ 1 year or\n   * \\< 50 years and in postmenopausal state ≥ 1 year with urine FSH \\> 40 IU\u002Fl and urine oestrogen \\< 30 ng\u002Fl, or serum follicle stimulating hormone (FSH) in the post-menopausal range or a negative oestrogen test.\n9. Male subjects must be willing to use a condom with sexual partners during this study and for a period of three months following the last administration of study medication until the follow-up visit. Male subjects must be willing to abstain from sperm donation for 3 months after the completion of this study\n\nExclusion Criteria:\n\n1. Comorbid obsessive-compulsive disorder (OCD), attention deficit\u002Fhyperactivity disorder (ADHD), depression, and anxiety disorder when unstable or in need of an initial adjustment for a therapy-according to the investigator's judgment\n2. Presence of severe psychiatric conditions such as developmental disability, psychotic illness and bipolar disorder- according to the investigator's judgment\n3. Ongoing behavioural treatment for tics\n4. History of schizophrenia, seizure, psychotic, severe personality, or pervasive developmental disorder\n5. Current clinical diagnosis of substance abuse or dependence\n6. History of cannabis dependence\n7. Secondary and other chronic tic disorders or other significant neurological disorders\n8. Known severe cardiac diseases, known severe cardiovascular diseases, known positivity for human immunodeficiency virus (HIV), hepatitis C, hepatitis B, or other severe hepatic and renal disorders by history\n9. Concomitant medications have to be on stable dose since at least 6 weeks before entering the study and must be well tolerated at baseline without causing dizziness, confusion, sedation, or somnolence)\n10. Use of cannabis or cannabinoid-based medicine (CBM) in the 30-day period prior to study entry and\u002For positive delta-9-tetrahydrocannabinol (THC) urine test at baseline\n11. Positive urine ß-HCG pregnancy test\n12. Pregnant or breast-feeding women\n13. Subjects who received any investigational medication or used any investigational device within 30 days prior to the first dose of study medication or is actively participating in any investigational drug or device study, or is scheduled to receive an investigational drug or to use an investigational device during the course of the study\n14. Subjects with a known allergy, hypersensitivity, or intolerance to the active substances and ingredients of study medication (e.g., cannabis, cannabinoids, or sesame oil)\n15. Any condition, which in the opinion of the investigator, would interfere with the evaluation of the study product or poses a health risk to the subject\n16. Subjects who are employees of the sponsor or employees or close relatives of the investigator\n17. Subjects with active suicidal ideation and behaviour (SI\u002FB) according to the Columbia-Suicide Severity Rating Scale (C-SSRS) and\u002For subjects that have attempted suicide in the past.","ALL","18 Years","65 Years",{"count":108,"type":109},164,"ESTIMATED","INTERVENTIONAL",[112],"PHASE2","To evaluate the efficacy, safety and tolerability of the cannabinoid-based medication SCI-110 compared to placebo in subjects with Tourette syndrome.",[115],"Tourette Syndrome","NOT_YET_RECRUITING","2026-04-16",{"date":119,"type":120},"2026-04-21","ACTUAL",{"date":122,"type":109},"2026-06",{"date":124,"type":109},"2028-02",{"name":5,"class":6},3]