[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05926765":3,"trial-entities:NCT05926765":339,"trial-summary:NCT05926765":343},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":57,"secondary_outcomes":62,"sex":69,"minimum_age":70,"maximum_age":17,"healthy_volunteers":71,"eligibility_criteria":72,"std_ages":97,"locations":100,"central_contacts":335,"overall_officials":336,"references":337,"see_also_links":338},"NCT05926765","MGT-AQP1-201","A Study of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia","A Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia","ACTIVE_NOT_RECRUITING","2027-06","2026-07","2026-07-24","2023-06-13","MeiraGTx, LLC","INDUSTRY",true,"This study will assess the efficacy and safety of bilateral intra-parotid administration of AAV2-hAQP1 in adults with Grade 2 or Grade 3 radiation-induced late xerostomia.",null,[19],"Grade 2 and 3 Late Xerostomia Caused by Radiotherapy for Cancers of the Upper Aerodigestive Tract, Excluding the Parotid Glands",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE2",{"count":26,"type":27},290,"ACTUAL",[29,35,40,47,52],{"type":30,"name":31,"description":32,"armGroupLabels":33},"GENETIC","AAV2-hAQP1 Concentration 1","Administration of concentration 1 of AAV2-hAQP1 via Stensen's duct to each parotid gland",[34],"Cohort 1: AAV2-hAQP1 Group 1",{"type":30,"name":36,"description":37,"armGroupLabels":38},"AAV2-hAQP1 Concentration 2","Administration of concentration 2 of AAV2-hAQP1 via Stensen's duct to each parotid gland",[39],"Cohort 1: AAV2-hAQP1 Group 2",{"type":41,"name":42,"description":43,"armGroupLabels":44},"OTHER","Placebo","Administration of diluent via Stensen's duct to each parotid gland",[45,46],"Cohort 1: Placebo group","Cohort 2 Placebo group",{"type":30,"name":48,"description":49,"armGroupLabels":50},"AAV2-hAQP1 Concentration 3","Administration of concentration 3 of AAV2-hAQP1 via Stensen's duct to each parotid gland",[51],"Cohort 2: AAV2-hAQP1 Group 3",{"type":30,"name":53,"description":54,"armGroupLabels":55},"AAV2-hAQP1 Concentration 4","Administration of concentration 4 of AAV2-hAQP1 via Stensen's duct to each parotid gland",[56],"Cohort 2: AAV2-hAQP1 Group 4",[58],{"measure":59,"description":60,"timeFrame":61},"Change from Baseline to Month 12 in Xerostomia-specific Questionnaire (XQ) Total Score","The XQ consists of 8 symptom-specific questions the participant rates from 0 (not present) to 10 (worst possible). The XQ Total Score is the sum of all individual item ratings and ranges from 0 to 80.","12 months",[63,66],{"measure":64,"description":65,"timeFrame":61},"Change from Baseline to Month 12 in unstimulated whole saliva flow rate","Change from Baseline to Month 12 in unstimulated whole saliva flow rate (mL\u002Fmin)",{"measure":67,"timeFrame":68},"The number of participants with treatment-emergent adverse events (AEs) and serious adverse events (SAEs)","from Baseline to Month 12","ALL","18 Years",false,{"inclusion":73,"exclusion":83,"raw_text":96},[74,75,76,77,78,79,80,81,82],"Completed beam radiation therapy for head and neck cancer at least 3 years prior to the first screening visit","No history of recurrent head and neck cancer, parotid gland cancer, or a second primary cancer, except for treated basal cell or squamous cell carcinoma of the skin or in situ cervical carcinoma","An unstimulated whole saliva flow rate (mL\u002Fmin) \\>0 (i.e., at least one drop of saliva in the collection tube)","A stimulated whole saliva flow rate (mL\u002Fmin) within a specified range after mechanical stimulation by chewing","Average screening XQ Total Score at or above a specified threshold","No evidence of head and neck cancer, defined as a negative otolaryngology exam and a negative computed tomography (CT) scan of the head, neck, and chest with contrast. If a participant has had a magnetic resonance imaging (MRI) study, CT scan, positron emission tomography (PET), or fluorodeoxyglucose-positron emission tomography (FDG-PET) scan of the head, neck, and chest within 6 months of signing the informed consent form (and at least 3 years after the completion of radiotherapy), then that scan may be used for eligibility determination and a CT scan at screening will not be required. If the CT of the neck captures images from the forehead down to the neck, no CT of the head is required.","Either received treatment with one or more prescription sialagogues and elected to discontinue therapy or, in consultation with their physician, elected not to initiate such treatment","Participants taking a prescription sialagogue (specifically, pilocarpine or cevimeline) must stop that medication at least 2 weeks prior to Screening and be willing to refrain from taking such medications for the duration of the study","Participants who require medication for an underlying medical condition that is known to affect salivary output must be on stable doses of such medications for at least one month prior to the first screening visit",[84,85,86,87,88,89,90,91,92,93,94,95],"History of recurrent head and neck cancer, parotid gland cancer, or a second primary cancer, except for treated basal cell or squamous cell carcinoma of the skin or in situ cervical carcinoma","History of systemic autoimmune disease affecting the salivary glands (e.g., Sjogren's disease)","Currently using systemic immunosuppressive medication(s) (e.g., corticosteroids or biologics) or treated with one within 4 weeks of the first screening visit. Note: Topical, inhaled, or intranasal corticosteroids are permitted.","Active viral infection with Epstein-Barr virus (EBV), defined as a positive anti-VCA IgM. In the event a potential participant has a positive anti-VCA IgM, they may be rescreened 2-4 months later at which time a positive Epstein-Barr Virus Nuclear Antigen (EBNA) will be considered as evidence of resolved EBV infection.","Evidence of active Hepatitis C virus (HCV) infection","Evidence of human immunodeficiency virus (HIV) infection","Diagnosis of myasthenia gravis","Personal or family history of acute or chronic angle-closure glaucoma (ACG), or at increased risk of developing ACG, or had prophylactic treatment to reduce the risk of developing ACG","Known allergy or hypersensitivity to glycopyrrolate","Current smokers or history of smoking within the preceding 3 years (includes vaping with tobacco additives)","Current alcohol misuse or a history of the same within the preceding 3 years, as defined by local guidance. In North America, an average intake for men of more than 14 drinks per week, and for women more than 7 drinks per week, consistent with the US National Institute of Alcohol Abuse and Alcoholism. In the UK, an average intake of more than 14 units per week for both men and women, consistent with the UK Chief Medical Officers' Low Risk Drinking Guidelines.","Poorly controlled diabetes (hemoglobin A1c \\>7%)","Inclusion Criteria:\n\n* Completed beam radiation therapy for head and neck cancer at least 3 years prior to the first screening visit\n* No history of recurrent head and neck cancer, parotid gland cancer, or a second primary cancer, except for treated basal cell or squamous cell carcinoma of the skin or in situ cervical carcinoma\n* An unstimulated whole saliva flow rate (mL\u002Fmin) \\>0 (i.e., at least one drop of saliva in the collection tube)\n* A stimulated whole saliva flow rate (mL\u002Fmin) within a specified range after mechanical stimulation by chewing\n* Average screening XQ Total Score at or above a specified threshold\n* No evidence of head and neck cancer, defined as a negative otolaryngology exam and a negative computed tomography (CT) scan of the head, neck, and chest with contrast. If a participant has had a magnetic resonance imaging (MRI) study, CT scan, positron emission tomography (PET), or fluorodeoxyglucose-positron emission tomography (FDG-PET) scan of the head, neck, and chest within 6 months of signing the informed consent form (and at least 3 years after the completion of radiotherapy), then that scan may be used for eligibility determination and a CT scan at screening will not be required. If the CT of the neck captures images from the forehead down to the neck, no CT of the head is required.\n* Either received treatment with one or more prescription sialagogues and elected to discontinue therapy or, in consultation with their physician, elected not to initiate such treatment\n* Participants taking a prescription sialagogue (specifically, pilocarpine or cevimeline) must stop that medication at least 2 weeks prior to Screening and be willing to refrain from taking such medications for the duration of the study\n* Participants who require medication for an underlying medical condition that is known to affect salivary output must be on stable doses of such medications for at least one month prior to the first screening visit\n\nExclusion Criteria:\n\n* History of recurrent head and neck cancer, parotid gland cancer, or a second primary cancer, except for treated basal cell or squamous cell carcinoma of the skin or in situ cervical carcinoma\n* History of systemic autoimmune disease affecting the salivary glands (e.g., Sjogren's disease)\n* Currently using systemic immunosuppressive medication(s) (e.g., corticosteroids or biologics) or treated with one within 4 weeks of the first screening visit. Note: Topical, inhaled, or intranasal corticosteroids are permitted.\n* Active viral infection with Epstein-Barr virus (EBV), defined as a positive anti-VCA IgM. In the event a potential participant has a positive anti-VCA IgM, they may be rescreened 2-4 months later at which time a positive Epstein-Barr Virus Nuclear Antigen (EBNA) will be considered as evidence of resolved EBV infection.\n* Evidence of active Hepatitis C virus (HCV) infection\n* Evidence of human immunodeficiency virus (HIV) infection\n* Diagnosis of myasthenia gravis\n* Personal or family history of acute or chronic angle-closure glaucoma (ACG), or at increased risk of developing ACG, or had prophylactic treatment to reduce the risk of developing ACG\n* Known allergy or hypersensitivity to glycopyrrolate\n* Current smokers or history of smoking within the preceding 3 years (includes vaping with tobacco additives)\n* Current alcohol misuse or a history of the same within the preceding 3 years, as defined by local guidance. In North America, an average intake for men of more than 14 drinks per week, and for women more than 7 drinks per week, consistent with the US National Institute of Alcohol Abuse and Alcoholism. In the UK, an average intake of more than 14 units per week for both men and women, consistent with the UK Chief Medical Officers' Low Risk Drinking Guidelines.\n* Poorly controlled diabetes (hemoglobin A1c \\>7%)",[98,99],"ADULT","OLDER_ADULT",[101,110,118,126,134,142,150,154,162,170,177,185,193,200,208,215,223,231,238,247,254,261,268,275,282,289,296,302,309,313,317,321,328],{"facility":102,"city":103,"state":104,"zip":105,"country":106,"geoPoint":107},"Banner MD Anderson Cancer Center","Gilbert","Arizona","85234","United States",{"lat":108,"lon":109},33.35283,-111.78903,{"facility":111,"city":112,"state":113,"zip":114,"country":106,"geoPoint":115},"City of Hope","Duarte","California","91010",{"lat":116,"lon":117},34.13945,-117.97729,{"facility":119,"city":120,"state":121,"zip":122,"country":106,"geoPoint":123},"Miami Cancer Institute at Baptist Health South Florida","Miami","Florida","33176",{"lat":124,"lon":125},25.77427,-80.19366,{"facility":127,"city":128,"state":129,"zip":130,"country":106,"geoPoint":131},"University of Iowa","Iowa City","Iowa","52242",{"lat":132,"lon":133},41.66113,-91.53017,{"facility":135,"city":136,"state":137,"zip":138,"country":106,"geoPoint":139},"Johns Hopkins Hospital","Baltimore","Maryland","21231",{"lat":140,"lon":141},39.29038,-76.61219,{"facility":143,"city":144,"state":145,"zip":146,"country":106,"geoPoint":147},"Tufts University School of Dental Medicine","Boston","Massachusetts","02111",{"lat":148,"lon":149},42.35843,-71.05977,{"facility":151,"city":144,"state":145,"zip":152,"country":106,"geoPoint":153},"Brigham and Women's Hospital","02120",{"lat":148,"lon":149},{"facility":155,"city":156,"state":157,"zip":158,"country":106,"geoPoint":159},"Henry Ford Health","Detroit","Michigan","48202",{"lat":160,"lon":161},42.33143,-83.04575,{"facility":163,"city":164,"state":165,"zip":166,"country":106,"geoPoint":167},"University of Missouri","Columbia","Missouri","65212",{"lat":168,"lon":169},38.95171,-92.33407,{"facility":171,"city":172,"state":165,"zip":173,"country":106,"geoPoint":174},"Washington University - St. Louis","St Louis","63110",{"lat":175,"lon":176},38.62727,-90.19789,{"facility":178,"city":179,"state":180,"zip":181,"country":106,"geoPoint":182},"Erie County Medical Center","Buffalo","New York","14215",{"lat":183,"lon":184},42.88645,-78.87837,{"facility":186,"city":187,"state":188,"zip":189,"country":106,"geoPoint":190},"UNC-Chapel Hill","Chapel Hill","North Carolina","27514",{"lat":191,"lon":192},35.9132,-79.05584,{"facility":194,"city":195,"state":188,"zip":196,"country":106,"geoPoint":197},"Atrium Health","Charlotte","28203",{"lat":198,"lon":199},35.22709,-80.84313,{"facility":201,"city":202,"state":203,"zip":204,"country":106,"geoPoint":205},"Penn State","Hershey","Pennsylvania","17033",{"lat":206,"lon":207},40.28592,-76.65025,{"facility":209,"city":210,"state":203,"zip":211,"country":106,"geoPoint":212},"Alleghany General Hospital","Pittsburgh","15212",{"lat":213,"lon":214},40.44062,-79.99589,{"facility":216,"city":217,"state":218,"zip":219,"country":106,"geoPoint":220},"Johnson City Medical Center","Johnson City","Tennessee","37604",{"lat":221,"lon":222},36.31344,-82.35347,{"facility":224,"city":225,"state":226,"zip":227,"country":106,"geoPoint":228},"UT Southwestern Medical Center","Dallas","Texas","75390",{"lat":229,"lon":230},32.78306,-96.80667,{"facility":232,"city":233,"state":226,"zip":234,"country":106,"geoPoint":235},"Houston Methodist","Houston","77030",{"lat":236,"lon":237},29.76328,-95.36327,{"facility":239,"city":240,"state":241,"zip":242,"country":243,"geoPoint":244},"Shirley and Jim Fielding Northeast Cancer Centre - Health Sciences North","Greater Sudbury","Ontario","P3E 5J1","Canada",{"lat":245,"lon":246},46.49,-80.99001,{"facility":248,"city":249,"zip":250,"country":243,"geoPoint":251},"Hopital Fleurimont, CIUSSS de l'Estrie-CHUS","Québec","J1H 5HE",{"lat":252,"lon":253},46.81228,-71.21454,{"facility":255,"city":256,"zip":257,"country":243,"geoPoint":258},"Princess Margaret Cancer Centre","Toronto","M5G 2C4",{"lat":259,"lon":260},43.70643,-79.39864,{"facility":262,"city":263,"zip":264,"country":243,"geoPoint":265},"CIUSSS-MCQ (Trois-Rivières, QC)","Trois-Rivières","G8Z 3R9",{"lat":266,"lon":267},46.34515,-72.5477,{"facility":269,"city":270,"country":271,"geoPoint":272},"Addenbrooke's Hospital","Cambridge","United Kingdom",{"lat":273,"lon":274},52.2,0.11667,{"facility":276,"city":277,"zip":278,"country":271,"geoPoint":279},"Cardiff and Vale NHS Trust - Head & Neck Services","Cardiff","CF14 4XW",{"lat":280,"lon":281},51.48,-3.18,{"facility":283,"city":284,"zip":285,"country":271,"geoPoint":286},"Ninewells Hospital & Medical School","Dundee","DD1 9SY",{"lat":287,"lon":288},56.46913,-2.97489,{"facility":290,"city":291,"zip":292,"country":271,"geoPoint":293},"Glasgow Royal Infirmary","Glasgow","LS2 9LU",{"lat":294,"lon":295},55.86515,-4.25763,{"facility":297,"city":298,"zip":292,"country":271,"geoPoint":299},"Leeds Dental Institute","Leeds",{"lat":300,"lon":301},53.79648,-1.54785,{"facility":303,"city":304,"zip":305,"country":271,"geoPoint":306},"Western General","London","EH4 2XU",{"lat":307,"lon":308},51.50853,-0.12574,{"facility":310,"city":304,"zip":311,"country":271,"geoPoint":312},"Guys Hospital","SE1 9RT",{"lat":307,"lon":308},{"facility":314,"city":304,"zip":315,"country":271,"geoPoint":316},"The Royal Marsden","SW3 6JJ",{"lat":307,"lon":308},{"facility":318,"city":304,"zip":319,"country":271,"geoPoint":320},"University College London Hospitals NHS Foundation Trust","WC1E 6DG",{"lat":307,"lon":308},{"facility":322,"city":323,"zip":324,"country":271,"geoPoint":325},"Nottingham University Hospitals NHS Trust","Nottingham","NG7 2UH",{"lat":326,"lon":327},52.9536,-1.15047,{"facility":329,"city":330,"zip":331,"country":271,"geoPoint":332},"York Hospital","York","YO31 8HE",{"lat":333,"lon":334},53.95763,-1.08271,[],[],[],[],{"nct_id":4,"conditions":340,"biomarkers":342},[341],"Xerostomia",[],{"nct_id":4,"found":15,"summary":344,"prompt_version":354},{"design":345,"status":346,"heading":347,"summary":348,"follow_up":349,"word_count":350,"commitments":351,"compensation":352,"drugs_mentioned":353},"This is an interventional study comparing different concentrations of AAV2-hAQP1 gene therapy to a placebo. It plans to enroll about 290 participants.","completed","Study of AAV2-hAQP1 Gene Therapy for Radiation-Induced Dry Mouth","This study is looking at a gene therapy called AAV2-hAQP1 for people who have severe dry mouth (xerostomia) caused by radiation treatment for head and neck cancer. You might be able to join if you completed radiation therapy at least three years ago and have Grade 2 or 3 dry mouth. The study will give different amounts of AAV2-hAQP1 or a placebo (an inactive substance) into your parotid glands (salivary glands in your cheeks). Researchers want to see if AAV2-hAQP1 is safe and helps improve your dry mouth symptoms, measured by a special questionnaire after 12 months. The current status of this study is unclear, and it plans to enroll about 290 participants.","Your dry mouth symptoms will be assessed for 12 months after treatment.",113,"Not specified in the trial record.","Not stated in the trial record.",[42],"v2"]