Chemotherapy Induced Peripheral Neuropathy (CIPN)NCT07499882
Intrathecal Ziconotide in Chemotherapy Induced Peripheral Neuropathy
An observational study of Chemotherapy Induced Peripheral Neuropathy (CIPN), run by Christian Hospital Northeast Northwest at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chemotherapy Induced Peripheral Neuropathy (CIPN)
- What is being tested?
- Ziconotide
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2026to 1 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patient, ages 18-100, with chemotherapy induced peripheral neuropathy that have not responded well to conservative measures
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Christian Hospital
St Louis, Missouri, 63136
Maksim Shoykhet, BSN, 314-653-5228, maksim.shoykhet@bjc.org
Cassandra Wania, BSN, 314-653-5228, cassandra.wania@bjc.org
About this study
Official title: Observational and Data Collection Study About Intrathecal Ziconotide in the Treatment of Chemotherapy Induced 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.
Read the 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.
- Being tested
- Ziconotide
- Keywords
- intrathecal pump, ziconotide, chronic pain, targeted drug delivery, neuropathy, cipn, chemotherapy induced neuropathy, neuropathy after cancer treatment
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 | Role | What they receive |
|---|---|---|
| Study group | This is the only group. All subjects will receive ziconotide via the Medtronic Synchromed intrathecal pump. Receives: Drug: Ziconotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start2 May 2026 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy Induced Peripheral Neuropathy (CIPN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christian Hospital Northeast Northwest
- Sponsor type
- University, hospital or other
- Collaborators
- TerSera Therapeutics LLC, TeamHealth
- Responsible party
- Principal investigator, Christopher Beuer, MD, Christian Hospital Northeast Northwest
- Investigators
- Christopher L Beuer, MD, Principal investigator, BJC TeamHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07499882
- Sponsor's protocol ID
- Beuer001
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Only overall study results will be shared. IPD will not be shared.
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.
PubMed 30909387Potocnik 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.
PubMed 41401064Piccolo 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.
PubMed 24352178
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational and Data Collection Study About Intrathecal Ziconotide in the Treatment of Chemotherapy Induced Neuropathy
- ClinicalTrials.gov ID
- NCT07499882
- Acronym / sponsor ID
- Beuer001
- Keywords
- intrathecal pump, ziconotide, chronic pain, targeted drug delivery, neuropathy, cipn, chemotherapy induced neuropathy, neuropathy after cancer treatment
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Christian Hospital Northeast NorthwestUniversity, hospital or other
- Collaborators
- TerSera Therapeutics LLC, TeamHealth
- Study start
- 2 May 2026 (estimated)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Drug: ZiconotideThis is the only group. All subjects will receive ziconotide via the Medtronic Synchromed intrathecal pump. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient, ages 18-100, with chemotherapy induced peripheral neuropathy that have not responded well to conservative measures
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZiconotideReal 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. | Drug | Study group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- BackgroundTersera Therapeutics, LLC. (2004). Prialt Prescribing Information.
- BackgroundWie 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: PubMed 30909387Zajaczkowska 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.
- Background: PubMed 41401064Potocnik 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.
- Background: PubMed 24352178Piccolo 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.
- Individual participant dataSharing planned: No. Only overall study results will be shared. IPD will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher L Beuer, MD principal investigator
BJC TeamHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chemotherapy Induced Peripheral Neuropathy (CIPN), run by Christian Hospital Northeast Northwest at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maksim Shoykhet, BSN (314-653-5228, maksim.shoykhet@bjc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07499882, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.