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NCT Number: NCT07499882

Intrathecal Ziconotide in Chemotherapy Induced Peripheral Neuropathy

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cassandra Wania, BSN

CONTACT

[email protected]

314-653-5228

Maksim Shoykhet, BSN

CONTACT

[email protected]

314-653-5228

Sponsors and collaborators

Lead sponsor

Christian Hospital Northeast Northwest

Other

Collaborators

  • TeamHealth
  • TerSera Therapeutics LLC

Registry information

Official study title

Observational and Data Collection Study About Intrathecal Ziconotide in the Treatment of Chemotherapy Induced Neuropathy

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 30, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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