[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04240821":3,"trial-entities:NCT04240821":80,"trial-summary:NCT04240821":84},{"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":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":39,"secondary_outcomes":44,"sex":48,"minimum_age":49,"maximum_age":50,"healthy_volunteers":15,"eligibility_criteria":51,"std_ages":56,"locations":60,"central_contacts":70,"overall_officials":71,"references":75,"see_also_links":76},"NCT04240821","IND 133013 Extension Study","Theophylline for Treatment of Pseudohypoparathyroidism","Open-Label Extension Study of Theophylline for Treatment of Pseudohypoparathyroidism","ENROLLING_BY_INVITATION","2026-12-31","2026-02","2026-04-28","2020-05-22","Jaclyn Tamaroff","OTHER",true,"Pseudohypoparathyroidism is a genetic disorder with limited treatment options, characterized by early-onset obesity, short stature, hormone resistance and cognitive impairment. This phase 2 clinical trial will test the efficacy of theophylline, a phosphodiesterase inhibitor, in pseudohypoparathyroidism. We hypothesize that theophylline will cause weight loss, improve glucose tolerance and decrease hormone resistance in children and young adults.","Trial Objectives\n\n1. The primary objective of this study is to evaluate the long-term safety of theophylline in patients with PHP.\n2. The secondary objectives of this study are to evaluate changes in BMI, hormone resistance and epiphyseal closure associated with theophylline treatment of patients with PHP.\n\nStudy Design The proposed study is a single center, 24-month open label extension clinical trial for patients with PHP who complete the randomized clinical trial.",[19,20,21],"Pseudohypoparathyroidism","Pseudohypoparathyroidism Type 1a","Albright Hereditary Osteodystrophy",[],"INTERVENTIONAL","TREATMENT",[26],"PHASE2",{"count":28,"type":29},34,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":37},"DRUG","Theophylline ER","Oral theophylline",[36],"Open-label theophylline",[38],"Theophylline elixir",[40],{"measure":41,"description":42,"timeFrame":43},"Adverse Events","Treatment-emergent adverse events will be compared before and during treatment","24 months",[45],{"measure":46,"description":47,"timeFrame":43},"BMI","Change in BMI","ALL","2 Years","99 Years",{"inclusion":52,"exclusion":54,"raw_text":55},[53],"1\\. Successful completion of the randomized clinical trial \"Phase 2 Study of Theophylline Treatment of Pseudohypoparathyroidism IND 133103 (11\u002F1\u002F2016)\".",[],"Inclusion Criteria:\n\n* 1\\. Successful completion of the randomized clinical trial \"Phase 2 Study of Theophylline Treatment of Pseudohypoparathyroidism IND 133103 (11\u002F1\u002F2016)\".\n\nExclusion Criteria:\n\n1. History of a seizure disorder unrelated to hypocalcemia\n2. History of a cardiac arrhythmia (not including bradycardia)\n3. Hepatic insufficiency including cirrhosis and acute hepatitis (AST or ALT \\>3x upper limit of normal)\n4. Congestive heart failure\n5. Current cigarette use or alcohol abuse\n6. Pregnancy or intention to become pregnant during the next year\n7. Active peptic ulcer disease\n8. Current use of medications known to effect theophylline levels\n9. History of hypersensitivity to theophylline or other medication components\n10. Unable to comply with study procedures in the opinion of the investigator",[57,58,59],"CHILD","ADULT","OLDER_ADULT",[61],{"facility":62,"city":63,"state":64,"zip":65,"country":66,"geoPoint":67},"Vanderbilt University Medical Center","Nashville","Tennessee","37212","United States",{"lat":68,"lon":69},36.16589,-86.78444,[],[72],{"name":73,"affiliation":62,"role":74},"Jaclyn Tamaroff, MD","PRINCIPAL_INVESTIGATOR",[],[77],{"label":78,"url":79},"Research Group Facebook Page","http:\u002F\u002Fwww.facebook.com\u002Fpseudohypoparathyroidism",{"nct_id":4,"conditions":81,"biomarkers":83},[82,19],"Albright's Hereditary Osteodystrophy",[],{"nct_id":4,"found":15,"summary":85,"prompt_version":95},{"design":86,"status":87,"heading":88,"summary":89,"follow_up":90,"word_count":91,"commitments":92,"compensation":93,"drugs_mentioned":94},"This is a single-center, open-label extension study for 34 participants who completed a previous randomized trial. It is a Phase 2 study.","completed","Theophylline for Pseudohypoparathyroidism","This study is testing the long-term effects of theophylline ER (a drug taken by mouth) for people with pseudohypoparathyroidism (PHP), a genetic condition affecting growth and hormones. Researchers want to see if theophylline ER can help with weight, how the body handles sugar, and hormone resistance. You can join if you are between 2 and 99 years old and have already finished a previous study on theophylline for PHP. The main goal is to check for any side effects over 24 months. This study is currently unclear about its recruitment status.","Participants will be followed for adverse events for 24 months.",91,"Not specified in the trial record.","Not stated in the trial record.",[33],"v2"]