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| Name | Class |
|---|---|
| TerSera Therapeutics LLC | INDUSTRY |
| TeamHealth | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | This is the only group. All subjects will receive ziconotide via the Medtronic Synchromed intrathecal pump. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ziconotide | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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. | From enrollment to the end of treatment at 24 months |
| 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. | From enrollment to the end of treatment at 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patient, ages 18-100, with chemotherapy induced peripheral neuropathy that have not responded well to conservative measures
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maksim Shoykhet, BSN | Contact | 314-653-5228 | maksim.shoykhet@bjc.org | |
| Cassandra Wania, BSN | Contact | 314-653-5228 | cassandra.wania@bjc.org |
| Name | Affiliation | Role |
|---|---|---|
| Christopher L Beuer, MD | BJC TeamHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christian Hospital | St Louis | Missouri | 63136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Tersera Therapeutics, LLC. (2004). Prialt Prescribing Information. | ||
| Background | Wie CS, Derian A. Ziconotide. [Updated 2025 Jan 19]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK459151/ | ||
| 30909387 | Background | 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/ijms20061451. | |
| 41401064 |
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Only overall study results will be shared. IPD will not be shared.
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C078452 | ziconotide |
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| Background |
| 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/raon-2025-0060. eCollection 2025 Dec 1. |
| 24352178 | Background | 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/ajhp130126. |