[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06726785":3,"trial-entities:NCT06726785":72,"trial-summary:NCT06726785":76},{"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":24,"primary_purpose":17,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":30,"secondary_outcomes":35,"sex":36,"minimum_age":37,"maximum_age":38,"healthy_volunteers":15,"eligibility_criteria":39,"std_ages":46,"locations":48,"central_contacts":64,"overall_officials":69,"references":70,"see_also_links":71},"NCT06726785","RLS_IRB_12415","Observe Change in Nasal Swab DRD2 Gene Expression in Restless Legs Syndrome (RLS) Patients on Prolonged Dopamine Agonist Treatment","Gene Expression Changes on Extended Use of Dopamine Agonists in Restless Legs Syndrome (RLS)","RECRUITING","2026-02-27","2025-09","2025-09-11","2025-07-01","HBC Immunology Inc","INDUSTRY",false,"The study aims to observe changes in dopaminergic genes expression in peripheral tissue upon prolonged dopamine agonist treatment on patients with Restless Legs Syndrome (RLS). Similar studies in Parkinson's disease have shown changes in alpha-synuclein expression, which might offer insights into the dopaminergic gene regulation seen in RLS. The dopamine agonist drugs to be included in this study are: Pramipexole (Mirapex), Ropinirole (Requip), Rotigotine (Neupro), Apomorphine (Apokyn), Bromocriptine (Parlodel). Specifically, the study will collect nasal swabs of participants partitioned into two groups, those who have not used a dopamine agonist or been on a dopamine agonist for less than 1 month compared to those who have been on the medication for 6 or more months. This research could provide insight into changes in dopaminergic gene expression associated with Augmentation Syndrome (AS) which occurs after long term dopamine agonist treatment in RLS patients.",null,[19],"Restless Leg Syndrome (RLS)",[21,22,23],"restless leg syndrome","RLS","neurological","OBSERVATIONAL",[],{"count":27,"type":28},50,"ESTIMATED",[],[31],{"measure":32,"description":33,"timeFrame":34},"To analyze the effect of duration of dopamine agonist treatments for changes in dopaminergic genes expression using nasal epithelial cells.","Gene expression will be measured and reported as the Fold change, which is the ratio of expression levels between the DRD2 experimental gene vs GAPDH housekeeping gene expression and reported as the Fold change which will indicate the magnitude of upregulation or downregulation of the DRD2 gene. A fold change \\>= 2 will be used as the minimum baseline to indicate upregulation and a fold change \\\u003C = 1\u002F2 will be used as the minimum baseline to indicate downregulation.","1 week",[],"ALL","18 Years","60 Years",{"inclusion":40,"exclusion":44,"raw_text":45},[41,42,43],"Able to provide Informed Consent","Clinical diagnosis of Restless Legs Syndrome (RLS)","On-going Treatment with a dopamine agonist",[],"Inclusion Criteria:\n\n* Able to provide Informed Consent\n* Clinical diagnosis of Restless Legs Syndrome (RLS)\n* On-going Treatment with a dopamine agonist\n\nExclusion Criteria:\n\n\\* Use of any medication that might affect nasal epithelial cell collection with a nasal swab",[47],"ADULT",[49],{"facility":50,"status":8,"city":51,"state":52,"zip":53,"country":54,"contacts":55,"geoPoint":61},"Alethios Inc","San Francisco","California","94109","United States",[56],{"name":57,"role":58,"phone":59,"email":60},"Zeenia Framroze, MA","CONTACT","650-206-8006","zeenia@alethios.com",{"lat":62,"lon":63},37.77493,-122.41942,[65],{"name":66,"role":58,"phone":67,"email":68},"Bomi Framroze, PhD","6502068006","bomi.framroze@hbcimmunology.com",[],[],[],{"nct_id":4,"conditions":73,"biomarkers":75},[74],"Restless Leg Syndrome",[],{"nct_id":4,"found":77,"summary":78,"prompt_version":88},true,{"design":79,"status":80,"heading":81,"summary":82,"follow_up":83,"word_count":84,"commitments":85,"compensation":86,"drugs_mentioned":87},"This is an observational study involving 50 participants. It compares gene expression in two groups: those on dopamine agonists for less than one month, and those on them for six months or more.","completed","Observing Gene Changes in Restless Legs Syndrome Patients on Dopamine Agonists","This observational study is looking at how long-term treatment with dopamine agonist medications like Pramipexole (Mirapex), Ropinirole (Requip), Rotigotine (Neupro), Apomorphine (Apokyn), and Bromocriptine (Parlodel) affects certain genes in people with Restless Legs Syndrome (RLS). Researchers will collect a nasal swab from participants to check for changes in these genes. The study aims to understand if the duration of dopamine agonist use leads to differences in gene expression. You may be able to join if you are between 18 and 60 years old, have RLS, and are currently taking a dopamine agonist. The study is currently unclear on its recruitment status and plans to enroll 50 participants.","The primary endpoint is measured at 1 week, indicating a short follow-up period for this specific measurement.",107,"The study involves collecting nasal swabs from participants. The primary endpoint is measured at 1 week.","Not stated in the trial record.",[],"v2"]