[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03701581":3,"trial-entities:NCT03701581":149,"trial-summary:NCT03701581":153},{"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":21,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":32,"interventions":35,"primary_outcomes":51,"secondary_outcomes":63,"sex":71,"minimum_age":72,"maximum_age":73,"healthy_volunteers":74,"eligibility_criteria":75,"std_ages":95,"locations":98,"central_contacts":135,"overall_officials":139,"references":143,"see_also_links":148},"NCT03701581","00003869","4-aminopyridine Treatment for Nerve Injury","4-aminopyridine Treatment for Nerve Injury Resulting From Radical Retro-Pubic Prostatectomy","RECRUITING","2028-12","2025-12","2025-12-17","2021-06-05","John Elfar","OTHER",true,"To evaluate the role of 4-aminopyridine (4-AP) on the course of recovery after peripheral nerve traction and\u002For crush injury. This study aims to test the hypothesis that 4-aminopyridine speeds the often slow and unpredictable recovery after peripheral nerve traction and\u002For crush injuries.","To evaluate the role of 4-AP on the recovery of nerve function we will be giving patients with prostate cancer who are undergoing robot assisted radical prostatectomy (RP) either 4-AP or placebo in the perioperative period. This population of patients was selected as nerve crush injury during RP is thought to contribute to erectile dysfunction and urinary continence post operatively.",[19,20],"Nerve Injury","Prostate Cancer",[22,23,24,25,26],"prostatectomy","erectile dysfunction","prostate cancer","nerve injury","incontinence","INTERVENTIONAL","TREATMENT",[30,31],"PHASE2","PHASE3",{"count":33,"type":34},70,"ESTIMATED",[36,46],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":42},"DRUG","4-Aminopyridine","FDA-approved tablets.",[41],"Group A: Investigational Treatment",[43,44,45],"4-AP","Fampridine","Dalfampridine",{"type":14,"name":47,"description":48,"armGroupLabels":49},"Placebo","Placebo will be tooled to look similar to the study drug.",[50],"Group B: Placebo",[52,56,59],{"measure":53,"description":54,"timeFrame":55},"Michigan Incontinence Sympton Index (M-ISI) (change over time)","Incontinence measurement (change over time)","Pre-operative visit, and every seven days (starting after surgery, i.e., 7 days post-op) for 6 months (up to 25 times).",{"measure":57,"description":58,"timeFrame":55},"International Index of Erectile Function (IIEF) (change over time)","Erectile function measurement tool. (change over time)",{"measure":60,"description":61,"timeFrame":62},"Placebo vs. Active Drug Questionnaire","Specific questions regarding patient blinding","through study completion, an average of 1 year",[64,68],{"measure":65,"description":66,"timeFrame":67},"Drug Diary","Subjects will record the time each day that they take the study drug\u002F placebo.","Daily for 90 days.",{"measure":69,"description":70,"timeFrame":55},"Attempted Sexual Activity Questionnaire","Sexual activity assessment","MALE","45 Years","75 Years",false,{"inclusion":76,"exclusion":84,"raw_text":94},[77,78,79,80,81,82,83],"Male patients with organ-confined, non-metastatic prostate cancer (stages cT1c-T2c), planning to undergo Robotic-Assisted Laparoscopic Bilateral Nerve Sparing Radical Prostatectomy (NSRP)","Prostate-Specific Antigen (PSA) levels less than 15 ng\u002Fml (within the last 12 months), with biopsy-proven prostate cancer, for whom postoperative adjuvant therapy (e.g. radiation or androgen deprivation therapy) is not expected to be needed","Ages 45-75","An Abridged International Index of Erectile Function-Erectile Function (IIEF-5) score of greater than or equal to 17 at time of screening","Has experienced at least 6 months of regular sexual activity and sexual activity during the 12 weeks prior to prostate biopsy or surgery","Willingness to abstain from treatments for Erectile Dysfunction until 3 months after surgery","Willingness to participate and able to provide informed consent",[85,86,87,88,89,90,91,92,93],"Planned adjuvant therapy after NSRP based on specimen pathology and stage of prostate cancer (stage T3 or greater), positive lymph nodes or positive surgical margins","Neo-adjuvant therapy prior to NSRP","History of recurrent prostate cancer","History of seizures, multiple sclerosis, stroke or any other diagnosed neurological disorder","History of non-organ confined or metastatic prostate cancer (clinical Stages T3 or greater)","History of known hypersensitivity to 4AP","Patients with history of penile surgery other than circumcision or endoscopic urethral stricture surgery","Renal impairment based on calculated GFR (GFR\\\u003C60 mL\u002Fmin)","Use of any other aminopyridine medications for any other indication","Inclusion Criteria\n\n* Male patients with organ-confined, non-metastatic prostate cancer (stages cT1c-T2c), planning to undergo Robotic-Assisted Laparoscopic Bilateral Nerve Sparing Radical Prostatectomy (NSRP)\n* Prostate-Specific Antigen (PSA) levels less than 15 ng\u002Fml (within the last 12 months), with biopsy-proven prostate cancer, for whom postoperative adjuvant therapy (e.g. radiation or androgen deprivation therapy) is not expected to be needed\n* Ages 45-75\n* An Abridged International Index of Erectile Function-Erectile Function (IIEF-5) score of greater than or equal to 17 at time of screening\n* Has experienced at least 6 months of regular sexual activity and sexual activity during the 12 weeks prior to prostate biopsy or surgery\n* Willingness to abstain from treatments for Erectile Dysfunction until 3 months after surgery\n* Willingness to participate and able to provide informed consent\n\nExclusion Criteria\n\n* Planned adjuvant therapy after NSRP based on specimen pathology and stage of prostate cancer (stage T3 or greater), positive lymph nodes or positive surgical margins\n* Neo-adjuvant therapy prior to NSRP\n* History of recurrent prostate cancer\n* History of seizures, multiple sclerosis, stroke or any other diagnosed neurological disorder\n* History of non-organ confined or metastatic prostate cancer (clinical Stages T3 or greater)\n* History of known hypersensitivity to 4AP\n* Patients with history of penile surgery other than circumcision or endoscopic urethral stricture surgery\n* Renal impairment based on calculated GFR (GFR\\\u003C60 mL\u002Fmin)\n* Use of any other aminopyridine medications for any other indication",[96,97],"ADULT","OLDER_ADULT",[99,126],{"facility":100,"status":8,"city":101,"state":102,"zip":103,"country":104,"contacts":105,"geoPoint":123},"University of Arizona","Tucson","Arizona","85724","United States",[106,110,114,117,120,121],{"name":107,"role":108,"email":109},"John Elfar, MD","CONTACT","elfar@arizona.edu",{"name":111,"role":108,"phone":112,"email":113},"Carly J Deal","520-626-6456","carlyjdeal@arizona.edu",{"name":115,"role":116},"Rashid Sayyid, MD","PRINCIPAL_INVESTIGATOR",{"name":118,"role":119},"Juan Chipollini, MD","SUB_INVESTIGATOR",{"name":107,"role":119},{"name":122,"role":119},"Benjamin Lee, MD",{"lat":124,"lon":125},32.22174,-110.92648,{"facility":127,"status":128,"city":129,"state":130,"zip":131,"country":104,"geoPoint":132},"University of Rochester","TERMINATED","Rochester","New York","14602",{"lat":133,"lon":134},43.15478,-77.61556,[136],{"name":137,"role":108,"phone":112,"email":138},"Andrea Horne","ahh@arizona.edu",[140,141],{"name":115,"affiliation":100,"role":116},{"name":107,"affiliation":100,"role":142},"STUDY_CHAIR",[144],{"pmid":145,"type":146,"citation":147},"38773595","DERIVED","Ghazi A, Osinski TL, Feng C, Horne A, Elfar J. 4-Aminopyridine treatment for nerve injury resulting from radical retro-pubic prostatectomy: a single-center double-blind, randomized, placebo-controlled study. Trials. 2024 May 21;25(1):332. doi: 10.1186\u002Fs13063-024-08102-z.",[],{"nct_id":4,"conditions":150,"biomarkers":152},[151],"Prostate Carcinoma",[],{"nct_id":4,"found":15,"summary":154,"prompt_version":164},{"design":155,"status":156,"heading":157,"summary":158,"follow_up":159,"word_count":160,"commitments":161,"compensation":162,"drugs_mentioned":163},"This interventional study plans to enroll 70 male participants. It compares 4-aminopyridine to a placebo.","completed","4-aminopyridine Treatment for Nerve Injury after Prostate Cancer Surgery","This study is testing whether 4-aminopyridine, an FDA-approved medication, can help men recover faster from nerve injury that can happen during prostate cancer surgery. This nerve injury can affect urinary control and erectile function. You would receive either 4-aminopyridine or a placebo (an inactive pill that looks the same). Researchers will measure changes in your urinary control and erectile function over time to see if 4-aminopyridine makes a difference. The study is for men aged 45 to 75 with specific types of prostate cancer who are having robotic-assisted surgery. The current status of this study is unclear, and it plans to enroll 70 participants.","Your urinary control and erectile function will be measured for 6 months after surgery. You will also complete a questionnaire through study completion, which averages 1 year.",104,"You would take either 4-aminopyridine or a placebo. Your urinary control and erectile function would be measured at a pre-operative visit and weekly for 6 months after surgery, up to 25 times.","Not stated in the trial record.",[38,47],"v2"]