NCT07499882

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
24mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
May 2026May 2028

First Submitted

Initial submission to the registry

March 19, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

May 2, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

March 19, 2026

Last Update Submit

March 25, 2026

Conditions

Chemotherapy Induced Peripheral Neuropathy (CIPN)

Keywords

intrathecal pumpziconotidechronic paintargeted drug deliveryneuropathycipnchemotherapy induced neuropathyneuropathy after cancer treatment

Outcome Measures

Primary Outcomes (3)

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

    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.

    From enrollment to the end of treatment at 24 months

  • Assess whether or not patients' answers to ODI change when receiving intrathecal ziconotide

    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.

    From enrollment to the end of treatment at 24 months

  • Assess whether or not patients' answers to PROMIS change when receiving intrathecal ziconotide

    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.

    From enrollment to the end of treatment at 24 months

Study Arms (1)

Study group

This is the only group. All subjects will receive ziconotide via the Medtronic Synchromed intrathecal pump.

Drug: Ziconotide

Interventions

ZiconotideDRUG

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.

Study group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patient, ages 18-100, with chemotherapy induced peripheral neuropathy that have not responded well to conservative measures

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christian Hospital

St Louis, Missouri, 63136, United States

Location

Related Publications (5)

  • Tersera Therapeutics, LLC. (2004). Prialt Prescribing Information.

    BACKGROUND

  • 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/

    BACKGROUND

  • 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: 30909387BACKGROUND

  • 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: 41401064BACKGROUND

  • 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: 24352178BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Interventions

ziconotide

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Christopher L Beuer, MD

    BJC TeamHealth

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maksim Shoykhet, BSN

CONTACT

314-653-5228maksim.shoykhet@bjc.org

Cassandra Wania, BSN

CONTACT

314-653-5228cassandra.wania@bjc.org

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director- Pain Management/Principal Investigator

Study Record Dates

First Submitted

March 19, 2026

First Posted

March 30, 2026

Study Start

May 2, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Only overall study results will be shared. IPD will not be shared.

Locations

US(1)