Observing the use of Ziconotide for treating severe chronic pain
Official title: OP2C : Prialt® Observatory in Clinical Practice
Run by Institut Cancerologie de l'Ouest · NCT04321408 · Data updated 2026-11-12
This study looks at how well Ziconotide works for people with severe chronic pain and whether it’s safe to use in real-life situations.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Institut Cancerologie de l'Ouest Academic / other |
| Locations | 17 sites (Angers and 16 other locations) |
| Status | Recruiting |
| Started | July 10, 2020 |
| Main results expected | September 2027 |
| Study ends | September 2027 |
| Registry record updated | August 17, 2025 |
| Trial ID | NCT04321408 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older who experience severe refractory chronic pain and are suitable for intrathecal analgesia with Ziconotide.
✕Probably not a fit
Patients with contraindications to Ziconotide will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on the use of Ziconotide, a potent analgesic administered via intrathecal injection, for patients suffering from refractory chronic pain. The study aims to gather data on its effectiveness and safety in clinical practice, particularly regarding the management of neuropsychiatric adverse reactions associated with its use. By analyzing real-world outcomes, the study seeks to enhance understanding of optimal dosing and administration practices for Ziconotide. The findings could help refine treatment protocols and improve patient care.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safe and effective use of Ziconotide, potentially improving pain management for patients with refractory chronic pain.
How similar studies have gone: While Ziconotide has been previously studied in randomized clinical trials, this observational approach aims to gather new data on its current clinical use, making it a novel contribution to the existing literature.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years old * Severe refractory chronic pain requiring intrathecal analgesia * Candidate for intrathecal analgesia treatment with ziconotide * Patient informed about the study and agreeing to take part in. Exclusion Criteria: * Contraindications to ziconotide
Where it's running
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University of Freiburg
Freiburg im Breisgau, Germany Recruiting -
Justus-Liebig-Universitat
Giessen, Germany Recruiting -
Jena University Hospital
Jena, Germany Recruiting -
Hospital Universitario Puerta Del Mar
Cadiz, Spain Recruiting -
Hospital General Universitario Santa Lucía
Cartagena, Spain Recruiting -
Hospital Universitario Virgen de las Nieves
Granada, Spain Recruiting
Show 11 more locations
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Hospital Complexo Hospitalario de Ourense
Ourense, Spain Recruiting -
Hospital Universitario Virgen del Rocío
Seville, Spain Recruiting -
Hospital Clínico Universitario de Valencia
Valencia, Spain Recruiting -
Institut de Cancerologie de L'Ouest
Angers, France Active not recruiting -
Centre Hospitalier Departemental La Roche Sur Yon
La Roche-sur-Yon, France Active not recruiting -
Centre Leon Berard
Lyon, France Active not recruiting -
Institut de Cancerologie de Montpellier
Montpellier, France Suspended -
Clinique Breteche
Nantes, France Suspended -
Chu Nice
Nice, France Suspended -
Institut Curie
Saint-Cloud, France Suspended -
Hopital - Foch
Suresnes, France Active not recruiting
Study contacts
- Study coordinator: Denis Dupoiron, Md
- Email: denis.dupoiron@ico.unicancer.fr
- Phone: +33 241352700
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.