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.
Intrathecal Ziconotide in Chemotherapy Induced Peripheral Neuropathy
Status
Not yet recruiting
Phase
Not applicable
Enrollment
24
Locations
1
Results
Not posted
Publications
3
Study summary
What the protocol is testing.
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.
Full 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
Treatment arms and agents.
Timeline
From registration to results.
First posted
Mar 30, 2026
Study start
May 2, 2026
Primary completion
May 1, 2028
Study completion
May 1, 2028
Results posted
Not reported
Registry updated
Mar 30, 2026
Outcomes
What the study measures.
Primary outcomes
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
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.
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
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.
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
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.
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 100 Years
- Sex
- ALL
- Healthy volunteers
- No
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
Study locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Christian Hospital
St Louis, Missouri, United States
Publications
Results and literature.
PMID 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/ijms20061451.PMID 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/raon-2025-0060. eCollection 2025 Dec 1.PMID 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/ajhp130126.
Related trials
More studies on Ziconotide.
NCT IDStudyPhase / statusEnrollmentUpdated
Evaluating the Effectiveness of AIT in the Treatment of Pain Related to Pancreatic Cancer
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Not applicable
Not yet recruiting
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Recruiting
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Ziconotide for Non-cancer Pain by Intrathecal Administration
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Not applicable
Recruiting
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Safety and Activity Study of Intrathecally Administered Ziconotide for Neuropathic Pain in Patients With Cancer
National Cancer Institute, Naples · Pain · Neuropathic Pain
Phase 2
Unknown
16
2023-03
Ziconotide as First-Line IDT
Albany Medical College · Neuropathic Pain
Phase 4
Completed
13
2021-01
Intrathecal Ziconotide Antalgic Efficacy for Severe Refractory Neuropathic
Hospices Civils de Lyon · Severe Refractory Neuropathic Pain · Spinal Cord Lesions
Phase 3
Unknown
44
2019-05
Patient Registry of Intrathecal Pain Management in Europe for Prialt (Ziconotide Intrathecal Infusion) and Alternative Drugs for the Management of Severe, Chronic Pain.
Eisai Limited · Pain Management · Severe Chronic Pain
Not applicable
Completed
219
2018-10
Single Shot Intrathecal Ziconotide for Painful Neuropathy or Myelopathy
Aaron Boster · Painful Myelopathy · Painful Neuropathy
Phase 4
Withdrawn
0
2018-09
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Put the record in context.
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