[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07499882":3,"trial-entities:NCT07499882":119,"trial-summary:NCT07499882":123},{"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":29,"primary_purpose":30,"phases":31,"enrollment_info":32,"interventions":35,"primary_outcomes":42,"secondary_outcomes":53,"sex":54,"minimum_age":55,"maximum_age":56,"healthy_volunteers":15,"eligibility_criteria":57,"std_ages":72,"locations":75,"central_contacts":97,"overall_officials":100,"references":103,"see_also_links":118},"NCT07499882","Beuer001","Intrathecal Ziconotide in Chemotherapy Induced Peripheral Neuropathy","Observational and Data Collection Study About Intrathecal Ziconotide in the Treatment of Chemotherapy Induced Neuropathy","NOT_YET_RECRUITING","2028-05-01","2026-03","2026-03-30","2026-05-02","Christian Hospital Northeast Northwest","OTHER",false,"The purpose of this observational, data collection, research is to evaluate if ziconotide, a commercially approved medication given by a FDA cleared intrathecal pump, for chronic pain is effective in the treatment of chemotherapy-induced peripheral neuropathy (CIPN) a common and often long-lasting side effect of cancer treatment.","Chemotherapy-induced peripheral neuropathy is a painful condition that significantly impacts quality of life following a patient's cancer treatment. This condition is often irreversible and fails to respond well to commonly utilized medications (most frequently Gabapentin, Lyrica, and Cymbalta) (Piccolo \\& Kolesar, 2014). While spinal cord stimulation is approved for the treatment of painful diabetic neuropathy, it is not approved for the treatment of chemotherapy-induced neuropathy. This often leaves a void in treatment options for those not responding to topical treatments or oral medications. Data from prior clinical studies have shown targeted drug delivery (TDD), using an implanted Medtronic Synchromed Intrathecal Pain Pump, has successfully treated patients with chemotherapy-induced peripheral neuropathy using opioids such as morphine (Potocnik et al., 2025). However, no study as of yet has focused on the potential role ziconotide, a non-opioid treatment given intrathecally, may play in the pain management of these patients.",[19],"Chemotherapy Induced Peripheral Neuropathy (CIPN)",[21,22,23,24,25,26,27,28],"intrathecal pump","ziconotide","chronic pain","targeted drug delivery","neuropathy","cipn","chemotherapy induced neuropathy","neuropathy after cancer treatment","OBSERVATIONAL",null,[],{"count":33,"type":34},24,"ESTIMATED",[36],{"type":37,"name":38,"description":39,"armGroupLabels":40},"DRUG","Ziconotide","Real world evidence trial. Patients that are on intrathecal ziconotide will be observed for two years, to determine whether or not this drug is effective for chemotherapy induced peripheral neuropathy.",[41],"Study group",[43,47,50],{"measure":44,"description":45,"timeFrame":46},"Assess whether or not patients' pain score from VAS changes when receiving intrathecal ziconotide","One primary objective of this observational study is to obtain data to assess the information collected from the Visual Analog Scale (VAS) in patients with chemotherapy-induced peripheral neuropathy after treatment with intrathecal ziconotide, over a 24-month period.","From enrollment to the end of treatment at 24 months",{"measure":48,"description":49,"timeFrame":46},"Assess whether or not patients' answers to ODI change when receiving intrathecal ziconotide","One primary objective of this observational study is to obtain data to assess the information collected from the Oswestry Disability Index (ODI) in patients with chemotherapy-induced peripheral neuropathy after treatment with intrathecal ziconotide, over a 24-month period.",{"measure":51,"description":52,"timeFrame":46},"Assess whether or not patients' answers to PROMIS change when receiving intrathecal ziconotide","One primary objective of this observational study is to obtain data to assess the information collected from the Patient Reported Outcomes Measurement Information System (PROMIS) in patients with chemotherapy-induced peripheral neuropathy after treatment with intrathecal ziconotide, over a 24-month period.",[],"ALL","18 Years","100 Years",{"inclusion":58,"exclusion":64,"raw_text":71},[59,60,61,62,63],"Adult patients, ages 18-100, with chemotherapy-induced peripheral neuropathy as a primary source of pain","The patient is already scheduled to be treated with TDD using ziconotide (no reported allergies to ziconotide or drug-drug interactions expected)","Patient will have, or is scheduled to have, Medtronic Synchromed Intrathecal Pump implanted by Dr. Beuer (outside of the research)","Patients already taking nonopioid analgesics will be allowed to continue their prescribed medication regimen.","Patients currently taking opioid analgesics must undergo a washout period of 2 weeks (prior to device implant) before participating in this study. Those unable to adhere to this washout period will be excluded",[65,66,67,68,69,70],"Patients with other forms of neuropathy (diabetic, idiopathic) will be excluded","Patients with a spinal cord stimulator will be excluded","Patients with contraindications to intrathecal ziconotide will be excluded","Patients who cannot sign the consent, participate in research activities, or those who require a legally authorized representative (LAR) will be excluded","Patients who are pregnant and\u002For nursing or planning to become pregnant are excluded","Also excluded are those inaccessible for follow-up, participation is excluded by local law, or a patient is currently enrolled or plans to enroll in a concurrent drug\u002Fdevice study","Inclusion Criteria:\n\n* Adult patients, ages 18-100, with chemotherapy-induced peripheral neuropathy as a primary source of pain\n* The patient is already scheduled to be treated with TDD using ziconotide (no reported allergies to ziconotide or drug-drug interactions expected)\n* Patient will have, or is scheduled to have, Medtronic Synchromed Intrathecal Pump implanted by Dr. Beuer (outside of the research)\n* Patients already taking nonopioid analgesics will be allowed to continue their prescribed medication regimen.\n* Patients currently taking opioid analgesics must undergo a washout period of 2 weeks (prior to device implant) before participating in this study. Those unable to adhere to this washout period will be excluded\n\nExclusion Criteria:\n\n* Patients with other forms of neuropathy (diabetic, idiopathic) will be excluded\n* Patients with a spinal cord stimulator will be excluded\n* Patients with contraindications to intrathecal ziconotide will be excluded\n* Patients who cannot sign the consent, participate in research activities, or those who require a legally authorized representative (LAR) will be excluded\n* Patients who are pregnant and\u002For nursing or planning to become pregnant are excluded\n* Also excluded are those inaccessible for follow-up, participation is excluded by local law, or a patient is currently enrolled or plans to enroll in a concurrent drug\u002Fdevice study",[73,74],"ADULT","OLDER_ADULT",[76],{"facility":77,"city":78,"state":79,"zip":80,"country":81,"contacts":82,"geoPoint":94},"Christian Hospital","St Louis","Missouri","63136","United States",[83,88,91],{"name":84,"role":85,"phone":86,"email":87},"Maksim Shoykhet, BSN","CONTACT","314-653-5228","maksim.shoykhet@bjc.org",{"name":89,"role":85,"phone":86,"email":90},"Cassandra Wania, BSN","cassandra.wania@bjc.org",{"name":92,"role":93},"Christopher L Beuer, MD","PRINCIPAL_INVESTIGATOR",{"lat":95,"lon":96},38.62727,-90.19789,[98,99],{"name":84,"role":85,"phone":86,"email":87},{"name":89,"role":85,"phone":86,"email":90},[101],{"name":92,"affiliation":102,"role":93},"BJC TeamHealth",[104,107,109,112,115],{"type":105,"citation":106},"BACKGROUND","Tersera Therapeutics, LLC. (2004). Prialt Prescribing Information.",{"type":105,"citation":108},"Wie CS, Derian A. Ziconotide. [Updated 2025 Jan 19]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https:\u002F\u002Fwww.ncbi.nlm.nih.gov\u002Fbooks\u002FNBK459151\u002F",{"pmid":110,"type":105,"citation":111},"30909387","Zajaczkowska R, Kocot-Kepska M, Leppert W, Wrzosek A, Mika J, Wordliczek J. Mechanisms of Chemotherapy-Induced Peripheral Neuropathy. Int J Mol Sci. 2019 Mar 22;20(6):1451. doi: 10.3390\u002Fijms20061451.",{"pmid":113,"type":105,"citation":114},"41401064","Potocnik I, Strazisar B, Lenasi H, Zupanc T. Breaking the pain barrier: implantable intrathecal pump therapy as a game-changer in cancer pain management. Radiol Oncol. 2025 Dec 16;59(4):477-487. doi: 10.2478\u002Fraon-2025-0060. eCollection 2025 Dec 1.",{"pmid":116,"type":105,"citation":117},"24352178","Piccolo J, Kolesar JM. Prevention and treatment of chemotherapy-induced peripheral neuropathy. Am J Health Syst Pharm. 2014 Jan 1;71(1):19-25. doi: 10.2146\u002Fajhp130126.",[],{"nct_id":4,"conditions":120,"biomarkers":122},[121],"Chemotherapy-Induced Peripheral Neuropathy",[],{"nct_id":4,"found":124,"summary":125,"prompt_version":135},true,{"design":126,"status":127,"heading":128,"summary":129,"follow_up":130,"word_count":131,"commitments":132,"compensation":133,"drugs_mentioned":134},"This is an observational study involving 24 participants. Researchers will observe patients who are already receiving ziconotide for their condition.","completed","Observational Study of Ziconotide for Chemotherapy-Induced Peripheral Neuropathy","This study is looking at how well ziconotide, a medication delivered directly into the spinal fluid (intrathecal), works for people experiencing chemotherapy-induced peripheral neuropathy (CIPN). CIPN is a painful side effect of cancer treatment. Researchers will observe 24 adult patients, aged 18 to 100, who are already receiving ziconotide through an implanted pump for their CIPN. Over two years, they will track changes in your pain scores and how your daily life is affected to see if ziconotide helps improve these symptoms. This is an observational study, meaning researchers will gather information from patients already using the treatment.","Participants will be followed for 24 months, from enrollment to the end of their treatment.",98,"Participants will be observed for two years, with pain scores and daily function assessed from enrollment to the end of treatment.","Not stated in the trial record.",[38],"v2"]