Intrathecal Ziconotide in Chemotherapy Induced Peripheral Neuropathy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorChristian Hospital Northeast Northwest
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Ziconotide
Treatment groups
24 Participants
are divided into 1 treatment groupSponsors and collaborators
Christian Hospital Northeast Northwest
Lead sponsor
TerSera Therapeutics LLC
Collaborator
TeamHealth
Collaborator
Source ClinicalTrials.gov