Intrathecal Ziconotide in Chemotherapy Induced Peripheral Neuropathy
Not yet recruitingNCT07499882
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Observational and Data Collection Study About Intrathecal Ziconotide in the Treatment of Chemotherapy Induced Neuropathy
- Conditions
- Chemotherapy Induced Peripheral Neuropathy (CIPN)
- Interventions
- Sponsor
- Christian Hospital Northeast Northwest
- Collaborators
- TerSera Therapeutics LLC; TeamHealth
- Start date
- 2026-05-02
- Primary completion
- 2028-05-01
- Sex
- All
- Age range
- from 18 Years to 100 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07499882