[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626008":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":23,"centralContacts":28,"locations":34,"responsibleParty":119,"collaborators":121,"id":131,"slug":132,"hasResults":133,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":133,"sex":139,"minAge":140,"maxAge":141,"enrollmentInfo":142,"targetDuration":32,"studyType":145,"phases":146,"briefSummary":148,"conditions":149,"keywords":151,"overallStatus":37,"whyStopped":32,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":167},{"fullName":5,"class":6},"University of Trieste","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Rett syndrome patients with MECP2 mutation and 5-40 years of age","EXPERIMENTAL","Subjects included in the study are female patients with a diagnosis of RTT, confirmed by mutation of the MECP2 gene, and who meet the inclusion\u002Fexclusion criteria of the study. The total number of participating patients is 54, aged between 5 and 40 years, divided into three groups of 18 patients each (5-10 years, 11-17 years and 18-40 years).\n\nThe study medication mirtazapine oral solution (MTZ) will be given once daily at bedtime. During the first 14 days of the treatment period, MTZ at Dose Level 1 will be used to achieve the planned target daily dose, according to age (3.75 mg for 5-10 yrs, 7.5 mg for 11-17 yrs and 15 mg \\>18 yrs, from day 1 to 14). From Day 15 to the end of week 24, Dose Level 2 will be achieved: 7.5 mg for 5-10 yrs, 15 mg for 11-17 yrs and 30 mg for \\> 18 yrs).",[13],"Drug: mirtazapine",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","mirtazapine","Study medication (3.75 mg, 7.5 mg, 15 mg, 30 mg of MTZ oral solution) will be given once daily at bedtime. During the first 14 days of the treatment period, the oral solution of the active drug at Dose Level 1 will be used to achieve the planned target daily dose, according to age (3.75 mg for 5-10 yrs, 7.5 mg for 11-17 yrs and 15 mg \\> 18 yrs, from day 1 to 14). From Day 15 to the end of week 24, Dose Level 2 will be achieved: 7.5 mg for 5-10 yrs, 15 mg for 11-17 yrs and 30 mg for \\> 18 yrs).",[9],[21,22],"MirtaPil oral solution","Remeron oral solution",[24],{"name":25,"affiliation":26,"role":27},"Enrico Tongiorgi, PhD","University of Trieste, Trieste - Italy","PRINCIPAL_INVESTIGATOR",[29],{"name":25,"role":30,"phone":31,"phoneExt":32,"email":33},"CONTACT","+39 348 73477322",null,"tongi@units.it",[35,60,78,97],{"facility":36,"status":37,"city":38,"state":32,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Unità di Neuropsichiatria Infantile, IRCCS, Istituto Giannina Gaslini, Genova","RECRUITING","Genova","16147","Italy","IT",{"type":43,"coordinates":44},"Point",[45,46],11.87211,45.21604,{"lat":46,"lon":45},[49,53,57],{"name":50,"role":30,"phone":51,"phoneExt":32,"email":52},"Lino Nobili, Prof, MD","0039 010 5636 2432","neuropsichiatria@gaslini.org",{"name":54,"role":30,"phone":55,"phoneExt":32,"email":56},"Giulia Prato, MD","0039 010 56363760","giuliaprato@gaslini.org",{"name":58,"role":59,"phone":32,"phoneExt":32,"email":32},"Ramona Cordani - ramonacordani@gaslini.org, MD","SUB_INVESTIGATOR",{"facility":61,"status":37,"city":62,"state":32,"zip":63,"country":40,"countryCode":41,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"UOC di Neuropsichiatria Infantile, Policlinico Universitario \"Gaetano Martino\" di Messina, University of Messina. Messina","Messina","98125",{"type":43,"coordinates":65},[66,67],15.55256,38.19394,{"lat":67,"lon":66},[70,74],{"name":71,"role":30,"phone":72,"phoneExt":32,"email":73},"Gabriella Di Rosa, Prof, MD","0039 349 7386079","neuropsichiatria.infantile@polime.it",{"name":75,"role":30,"phone":76,"phoneExt":32,"email":77},"Antonio G Nicotera, MD","0039 090 2212911","antoniogennaro.nicotera@polime.it",{"facility":79,"status":37,"city":80,"state":32,"zip":81,"country":40,"countryCode":41,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Centro Epilessia - Unità Neurologia Pediatrica, ASST Ospedale Santi Carlo Paolo - Dipartimento Scienze della Salute, Università di Milano","Milan","20142",{"type":43,"coordinates":83},[84,85],12.59836,42.78235,{"lat":85,"lon":84},[88,92,95],{"name":89,"role":30,"phone":90,"phoneExt":32,"email":91},"Maria Paola Canevini, Prof. MD","0039 02 8184.4201","epilessia.hsp@asst-santipaolocarlo.it",{"name":93,"role":30,"phone":32,"phoneExt":32,"email":94},"Ilaria Viganò, MD","ilaria.vigano@asst-santipaolocarlo.it",{"name":96,"role":27,"phone":32,"phoneExt":32,"email":32},"Aglaia Vignoli - aglaia.vignoli@unimi.it, Prof, MD",{"facility":98,"status":37,"city":99,"state":32,"zip":100,"country":40,"countryCode":41,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Unità di Pediatria, Dipartimento della Donna e dei Bambini - Policlinico S. M. alle Scotte. Siena","Siena","53100",{"type":43,"coordinates":102},[103,104],11.33064,43.31822,{"lat":104,"lon":103},[107,111,115,117],{"name":108,"role":30,"phone":109,"phoneExt":32,"email":110},"Salvatore Grosso, Prof, MD","0039 0577 586547","salvatore.grosso@ao-siena.toscana.it",{"name":112,"role":30,"phone":113,"phoneExt":32,"email":114},"Claudio De Felice, MD","0039 347 330.9885","geniente@gmail.com",{"name":116,"role":59,"phone":32,"phoneExt":32,"email":32},"Michele Minerva - michele.minerva@ao-siena.toscana.it, MD",{"name":118,"role":59,"phone":32,"phoneExt":32,"email":32},"Valeria Scandurra - valeria.scandurra@ao-siena.toscana.it, MD",{"type":27,"investigatorFullName":25,"investigatorTitle":120,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Full Professor",[122,125,127,129],{"name":123,"class":124},"Policlinico G . Martino, Messina Italy","UNKNOWN",{"name":126,"class":124},"IRCSS Gianna Gaslini, Genova, Italy",{"name":128,"class":124},"Policlinico S.Maria alle Scotte, Siena, Italy",{"name":130,"class":124},"ASST Ospedale Santi Paolo e Carlo, Milano, Italy","100626008","phase-2-repurposing-mirtazapine-in-rett-syndrome-100626008",false,"NCT07430046","Repurposing Mirtazapine in Rett Syndrome","Repurposing Mirtazapine in Rett Syndrome: a Multicentric Open Label Phase II Study","MirtaRett","INCLUSION CRITERIA\n\n* 1\\. Female aged 5 to 39 years inclusive, at the time of signing the informed consent.\n* 2\\. Girls of childbearing age negative to pregnancy test;\n* 3\\. Body weight \\> 10 kg. and within the expected range for RTT, based on age and height.\n* 4\\. Diagnosis of RTT based on consensus clinical criteria (Neul, 2010) and a confirmed mutation in MECP2 gene.\n* 5\\. Breathing dysfunction (at least one of the following): period apnoea, intermittent hyperventilation, breath holding spells, air swallowing, forced expulsion of air and \u002For saliva.\n* 6\\. Ten episodes or more\u002Fday of breathing dysfunction during wakefulness in the week prior to the screening visit (parents report).\n\n  7\\. Stable medication regimen for 4 weeks prior to beginning the study (if receiving services - physical, occupational, or speech therapy - subjects must be on a stable regimen of these services for 3 months prior to beginning the study).\n* 8\\. Female patients of childbearing potential must use a highly effective contraceptive method such as combined hormonal contraception (containing estrogen and progestin) associated with ovulation suppression (oral, intravaginal, transdermal); progestin-only hormonal contraception associated with ovulation suppression (oral, injectable, implantable); intrauterine device; hormone-releasing intrauterine system. Sexual abstinence is considered a highly effective contraceptive method if it aligns with the individual's usual lifestyle. Female patients of childbearing potential are to use adequate contraception as recommended by their Health Care Provider.\n* 9\\. Written consent signed by parent\u002Flegal guardian\u002Frepresentative prior to screening visit\n* 10\\. Patient is cooperative, willing to complete the study, and capable of doing so with assistance of a caregiver.\n* 11\\. Caregiver is able to understand the instructions and fully participate.\n\nEXCLUSION CRITERIA\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Patient is participating to another investigational clinical trial.\n* Hypersensitivity to MTZ or any of the other ingredients of Mirtapil®.\n* Clinically significant (as determined by the investigator) cardiovascular, respiratory, gastrointestinal, renal, hepatic, haematological pathologies or other pathologies, in addition to those directly related to RTT. In particular, patients with the following parameters will be excluded: leucocyte count is \\\u003C 4000\u002Fmm2; neutrophil count is \\\u003C 2000\u002Fmm3; hyponatremia (\\\u003C 125 mmol\u002FL); renal dysfunction (creatinine \\> 2 X ULN), hepatic dysfunction (AST, ALT, bilirubin \\> 2 X ULN); or if severe diabetes mellitus is present.\n* QTcF interval on the ECG greater than 450 msec\n* Surgery planned during the study.\n* Severe diabetes mellitus (hyperglycaemia with values above 250\u002F300 mg\u002FdL);\n* Pregnancy, breastfeeding.\n* Evidence of clinically significant malnutrition with BMI (or BMI) (kg\u002Fm2) \\\u003C\n* Patients who manifested prior suicidal ideation.","FEMALE","5 Years","40 Years",{"count":143,"type":144},54,"ESTIMATED","INTERVENTIONAL",[147],"PHASE2","Rett Syndrome (RTT) is a rare neurodevelopmental disorder caused by an MECP2 gene mutation on the X chromosome, primarily affecting females. It causes progressive motor and cognitive decline, loss of speech, repetitive hand movements, breathing issues, seizures, and sleep problems. Given RTT's association with reduced monoamine levels, antidepressants like mirtazapine (MTZ) may help.Preclinical studies in MeCP2-mutant mice and early adult RTT trials showed that MTZ improved respiratory, motor, and neurological function, sleep, and mood, prompting this pediatric and young adult study. The MirtaRett trial is a multicenter, open-label, single-arm, phase II study enrolling 54 female RTT patients (ages 5-40), divided into groups of 18 (5-10, 11-17, 18-40 years). It aims to evaluate MTZ's safety and efficacy for mood, sleep, and motor symptoms, particularly hand control. Other ares of investigation include autonomic function, behavior, caregiver burden, clinical severity, and neuronal plasticity and metabolic biomarkers. Patients will receive escalating doses of MTZ oral solution: initial low doses (3.75-15 mg\u002Fday) for two weeks, followed by optimal doses (7.5-30 mg\u002Fday) for six months. Safety, tolerability, and symptoms will be monitored over 10 months (3-month screening, 6-month treatment, 1-month follow-up). The study is conducted at four Italian RTT-specialized hospitals, led by the University of Trieste. Partner sites are in Italy, specifically at the hospitals in Milan, Genova, Siena, and Messina.",[150],"RETT Syndrome With Proven MECP2 Mutation",[152,17,153,154,155,156,157],"antidepressant","motor dysfunction","cognitive impairment","sleep disorder","cognitive disability","parent stress","2026-02-17",{"date":160,"type":161},"2026-02-24","ACTUAL",{"date":163,"type":161},"2025-07-09",{"date":165,"type":144},"2026-12-31",{"name":5,"class":6},4]