Clinical trial · Observational
Intrathecal Ziconotide in Chemotherapy Induced Peripheral Neuropathy
Observational and Data Collection Study About Intrathecal Ziconotide in the Treatment of Chemotherapy Induced Neuropathy
NCT07499882CI-TRIAL-00106716not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy Induced Peripheral Neuropathy (CIPN) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ziconotide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Study group
- description
- This is the only group. All subjects will receive ziconotide via the Medtronic Synchromed intrathecal pump.
- interventionNames
- Drug: Ziconotide
Primary outcomes (3)
- measure
- Assess whether or not patients' pain score from VAS changes when receiving intrathecal ziconotide
- timeFrame
- From enrollment to the end of treatment at 24 months
- description
- 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.
- measure
- Assess whether or not patients' answers to ODI change when receiving intrathecal ziconotide
- timeFrame
- From enrollment to the end of treatment at 24 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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/or 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/device study
References
Publications (5)
- BACKGROUNDTersera Therapeutics, LLC. (2004). Prialt Prescribing Information.
- BACKGROUNDWie 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/
- BACKGROUNDZajaczkowska 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. PMID 30909387
- BACKGROUNDPotocnik 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. PMID 41401064
- BACKGROUNDPiccolo 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. PMID 24352178