[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fenix Innovation Group\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":75},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"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":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100612773","phase-3-nti164-in-autism-spectrum-disorder-100612773",false,"NCT07257939","NTI164 in Autism Spectrum Disorder","A Phase III Double-blind, Randomised, Placebo-controlled Study Investigating the Efficacy and Safety of NTI164 in Children and Young Adults With Autism Spectrum Disorder","HarmonyPlus","Inclusion Criteria:\n\n1. Participant is aged 6 years to 25 years (inclusive).\n2. Participant is at a healthy weight at the discretion of the Principal Investigator.\n3. Written informed consent from parent or legal guardian according to the local law.\n4. Participants can comply with trial requirements.\n5. According the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria the participant has a diagnosis of Level II or III ASD confirmed by a validated assessment tool.\n6. All treatments including medications and therapies for ASD related symptoms must have been stable for 12 weeks before enrolment and for the duration of the trial wherever possible.\n7. Participants must be able to swallow liquid.\n8. Consent giver must be able to understand the requirements of the study.\n\nExclusion Criteria:\n\n1. Current diagnosis of bipolar disorder, psychosis, schizophrenia, schizoaffective disorder, or active major depression.\n2. Has a diagnosis other than ASD that dominates the clinical presentation (e.g., ADHD).\n3. Has a degenerative condition.\n4. Changes in anticonvulsive therapy within the last 12 weeks.\n5. Taking omeprazole, lansoprazole, tolbutamide, warfarin, sirolimus, everolimus, temsirolimus, tacrolimus, clobazam, repaglinide, pioglitazone, rosiglitazone, montelukast, bupropion, or efavirenz.\n6. Currently using or has used recreational or medicinal cannabis, cannabinoid-based medications (including Sativex®, or Epidiolex®) within the 12 weeks prior to screening and is unwilling to abstain for the duration of the trial.\n7. Participant has any known or suspected hypersensitivity to cannabinoids or any of the excipients.\n8. Participant has moderately impaired hepatic function at screening, defined as serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 2 × upper limit of normal (ULN) or total bilirubin (TBL) \\> 2 × ULN. This criterion can only be confirmed once the laboratory results are available; participants enrolled into the trial who are later found to meet this criterion must be screen-failed.\n9. Participant is male and fertile (i.e., after puberty unless permanently sterile by bilateral orchidectomy) unless willing to ensure that they use male contraception (condom) or remain sexually abstinent during the trial and for 12 weeks thereafter.\n10. Participant is female and with childbearing potential (i.e., following menarche and until becoming postmenopausal for ≥ 12 consecutive months unless permanently sterile by hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) unless willing to ensure that they use a highly effective method of birth control (e.g., hormonal contraception, intrauterine device\u002Fhormone-releasing system, bilateral tubal occlusion, vasectomised partner, sexual abstinence) during the trial and for 12 weeks thereafter.\n11. Female participant who is pregnant (positive pregnancy test), lactating or planning pregnancy during the course of the trial or within 12 weeks thereafter.\n12. Participant had brain surgery or traumatic brain injury within 1 year of screening.\n13. Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant, other participants, or site staff at risk because of participation in the trial, may influence the result of the trial, or may affect the participant's ability to take part in the trial.\n14. Any abnormalities identified following a physical examination of the participant that, in the opinion of the Investigator, would jeopardise the safety of the participant if they took part in the trial.\n15. Any history of suicidal behaviour (lifelong) or any suicidal ideation of type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) in the last 12 weeks or at screening or randomisation.\n16. Participant has donated blood during the past 12 weeks and is unwilling to abstain from donation of blood during the trial.\n17. Participant has any known or suspected history of alcohol or substance abuse or positive drugs of abuse test at screening (not justified by a known concurrent medication).\n18. Participant has previously been enrolled into this trial.\n19. Participant has plans to travel outside their country of residence during the trial, unless the participant has confirmation that the product is permitted in the destination country\u002Fstate.","ALL","6 Years","25 Years",{"count":21,"type":22},98,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This is a double-blind, randomised, placebo-controlled study investigating the efficacy of a full-spectrum medicinal cannabis plant extract on core and associated ASD symptoms over placebo. Participants will be randomly allocated to either NTI164 or placebo at a 1:1 ratio and blood samples will be collected and surveys completed at baseline and Week 16. This study will expand efficacy and safety data of NTI164 and provide additional mechanism of action data of NTI164 in this patient cohort.",[28,29,30],"Autism","Autism Spectrum Disorder","Autism Disorder",[32,33,34],"Cannabis","NTI164","Autism spectrum disorder","NOT_YET_RECRUITING","2025-11-26",{"date":38,"type":39},"2025-12-02","ACTUAL",{"date":41,"type":22},"2026-07-01",{"date":43,"type":22},"2030-07-01",{"name":45,"class":46},"Fenix Innovation Group","INDUSTRY",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":56,"minAge":57,"maxAge":19,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":72,"leadSponsor":74,"locationsCount":47},"100612776","phase-2-efficacy-and-safety-of-nti164-in-children-and-young-adults-with-rett-syndrome-100612776","NCT07257978","Efficacy and Safety of NTI164 in Children and Young Adults With Rett Syndrome","A Phase II\u002FIII Double-blind, Randomised, Placebo-controlled, Crossover Study Investigating the Efficacy and Safety of NTI164 in Children and Young Adults With Rett Syndrome","TRANSCEND","Inclusion Criteria:\n\n1. Females aged 4-25 years of age\n2. Weight ≥12 kg\n3. Classical\u002Ftypical RTT as confirmed with a documented pathogenic variant in the MECP2 gene\n4. At least 6 months post-regression at screening (i.e. no loss or degradation in ambulation, hand function, speech, non-verbal communication, or social skills within 6 months of screening)\n5. Rett Syndrome Clinical Severity Scale rating of 10-36\n6. Clinical Global Impression - Severity of Illness score ≥4\n7. Stable pattern of seizures or has had no seizures within 8 weeks of screening, as determined by the participant's primary physician\n8. Other patient medications must be stable (i.e. no dose adjustments) for at least 8 weeks prior to screening, including steroids, anti-inflammatories, anxiolytics etc\n\nExclusion Criteria:\n\n1. Current clinically significant cardiovascular, endocrine (such as hypo- or hyperthyroidism, type 1 diabetes, or uncontrolled type 2 diabetes), renal, hepatic, respiratory, or gastrointestinal disease (such as coeliac disease or inflammatory bowel disease), or major surgery planned\n2. Known history or symptoms of long QT syndrome\n3. QTcF interval \\>450 milliseconds, history of risk factor for torsades de pointes or clinically significant QT prolongation deemed to increase risk\n4. Currently receiving treatment with DAYBUE™ (Trofinetide)\n5. Currently using other unregistered drugs for the treatment of Rett syndrome, such as Anavex®\n6. Currently using or has used recreational or medicinal cannabis or cannabinoid-based medications, including Sativex® or Epidiolex®, within the 12 weeks prior to screening and is unwilling to abstain for the duration of the trial\n7. A known or suspected hypersensitivity to cannabinoids or any of the excipients\n8. Moderate-severe impairment in hepatic function at screening, defined as serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 2 x upper limit of normal (ULN), or total bilirubin (TBL) \\> 2 x ULN. This criterion can only be confirmed once laboratory results are available, participants enrolled into the trial who are later found to meet this criterion will be screen-failed.\n9. Participant is enrolled in another clinical trial within 14 days of screening or becomes enrolled in another clinical trial throughout the duration of this study\n10. Infection and\u002For antibiotic use in the 2 weeks prior to screening (participants can be recruited following 2 weeks without infection and\u002For antibiotic use)","FEMALE","4 Years",{"count":59,"type":22},40,[61,25],"PHASE2","The FENRTT2 study will investigate the efficacy and safety of a medicinal cannabis plant extract with extremely low THC (delta-9-tetrahydrocannabinol), NTI164, on Rett syndrome (RTT) in a crossover design. RTT is a devastating rare genetic condition affecting females and involves debilitating physical and intellectual symptoms. NTI164 is an oil which has demonstrated efficacy in reducing symptoms in several paediatric neurological conditions, including RTT, autism spectrum disorder (ASD), and paediatric acute-onset neuropsychicatric syndrome (PANS). A Phase I\u002FII clinical trial of NTI164 in RTT (FENRTT1\u002FNTIRTT1) showed NTI164 is safe in this population and significantly improved overall clinical severity of illness, as well as core RTT symptoms, including anxiety, mental alertness, communication skills, socialisation\u002Feye contact, and attentiveness. The FENRTT2 study will investigate NTI164 in a larger number of patients, and compare NTI164 to a placebo control. Research tests on patient blood will also be included to further investigate how NTI164 works in the body.",[64,65],"RETT Syndrome With Proven MECP2 Mutation","Rett Syndrome",[67,68,69,33],"Rett syndrome","Rett","cannabis",{"date":38,"type":39},{"date":41,"type":22},{"date":73,"type":22},"2028-10-01",{"name":45,"class":46},""]