Intrathecal Ziconotide in Chemotherapy Induced Peripheral Neuropathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ziconotide.
- Who it may be relevant to
- Registry conditions: Chemotherapy Induced Peripheral Neuropathy (CIPN). Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Observational and Data Collection Study About Intrathecal Ziconotide in the Treatment of Chemotherapy Induced Neuropathy
Overview
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.
Detailed description
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.
Interventions
- 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.
Primary outcome measures
- Assess whether or not patients' pain score from VAS changes when receiving intrathecal ziconotide [Time frame: From enrollment to the end of treatment at 24 months]
- Assess whether or not patients' answers to ODI change when receiving intrathecal ziconotide [Time frame: From enrollment to the end of treatment at 24 months]
- Assess whether or not patients' answers to PROMIS change when receiving intrathecal ziconotide [Time frame: From enrollment to the end of treatment at 24 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- Christian Hospital — St Louis
Publications
- Tersera Therapeutics, LLC. (2004). Prialt Prescribing Information.
- 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/
- 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. PMID 30909387
- 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. PMID 41401064
- 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. PMID 24352178
Identifiers
NCT: NCT07499882 · Beuer001