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Observational Study of Ziconotide for Chemotherapy-Induced Peripheral Neuropathy

This study is looking at how well ziconotide, a medication delivered directly into the spinal fluid (intrathecal), works for people experiencing chemotherapy-induced peripheral neuropathy (CIPN). CIPN is a painful side effect of cancer treatment. Researchers will observe 24 adult patients, aged 18 to 100, who are already receiving ziconotide through an implanted pump for their CIPN. Over two years, they will track changes in your pain scores and how your daily life is affected to see if ziconotide helps improve these symptoms. This is an observational study, meaning researchers will gather information from patients already using the treatment.

Study design
This is an observational study involving 24 participants. Researchers will observe patients who are already receiving ziconotide for their condition.
What's involved
Participants will be observed for two years, with pain scores and daily function assessed from enrollment to the end of treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 24 months, from enrollment to the end of their treatment.

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NCT07499882

Intrathecal Ziconotide in Chemotherapy Induced Peripheral Neuropathy

Not Yet Recruiting
Not specifiedAges 18+Observational
Christian Hospital Northeast Northwest
~24 participants
Updated 2026-03-30 on ClinicalTrials.gov
What's tested:Ziconotide

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assess whether or not patients' pain score from VAS changes when receiving intrathecal ziconotide
Measured over From enrollment to the end of treatment at 24 months
+2 more outcomes measured

Conditions

Chemotherapy Induced Peripheral Neuropathy (CIPN)

Explore related trials

Chemotherapy-Induced Peripheral Neuropathy

Where it's being run

1 sites across 1 states
Missouri1

Study leadership

  • Christopher L Beuer, MD · PRINCIPAL_INVESTIGATOR · BJC TeamHealth

Who to contact

Maksim Shoykhet, BSN
[email protected]
314-653-5228
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Assess whether or not patients' pain score from VAS changes when receiving intrathecal ziconotideFrom 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 ziconotideFrom 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 ziconotideFrom 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.