OP2C : Prialt® Observatory in Clinical Practice
Recruiting now
Conditions studied: Refractory Pain
In brief
Ziconotide is a strong analgesic marketed since 2005 in Europe and reserved for the intrathecal route. Its efficacy has been proven in particular by 3 randomized clinical studies. It is particularly effective on neuropathic pain and its main advantages are its power of action, the absence of bone marrow toxicity, and the absence of respiratory depression. In addition, there were no signs of withdrawal when stopping the drug, or of tachyphylaxis. However, during these studies many adverse reactions were highlighted, especially neuropsychiatric which limited its use. This toxicity was mainly related to the administration of too high doses, especially at the start of treatment (too fast titration). In recent years, the use of intrathecal ziconotide has become a pertinent option. Indeed, it is recommended as first-line among the intrathecal treatment options. However, there is a lack of data on the current use of ziconotide in current practice. The objective of the study will be to describe the practical methods of using intrathecal treatments containing ziconotide.
Key facts
- Study ID
- NCT04321408
- Run by
- Institut Cancerologie de l'Ouest
- People needed
- 300
- Starts
- 2020-07-10
- Expected to finish
- 2027-09-01
- Last updated by the study team
- 2025-08-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Contraindications to ziconotide
Where it is running
- Hospital Clínico Universitario de Valencia — Valencia, Spain (enrolling)
- University of Freiburg — Freiburg im Breisgau, Germany (enrolling)
- Justus-Liebig-Universitat — Giessen, Germany (enrolling)
- Jena University Hospital — Jena, Germany (enrolling)
- Hospital Universitario Puerta Del Mar — Cadiz, Spain (enrolling)
- Hospital General Universitario Santa Lucía — Cartagena, Spain (enrolling)
- Hospital Universitario Virgen de las Nieves — Granada, Spain (enrolling)
- Hospital Complexo Hospitalario de Ourense — Ourense, Spain (enrolling)
- Hospital Universitario Virgen del Rocío — Seville, Spain (enrolling)
- Centre Hospitalier Departemental La Roche Sur Yon — La Roche-sur-Yon, France
- Centre Leon Berard — Lyon, France
- Institut de Cancerologie de Montpellier — Montpellier, France
- Clinique Breteche — Nantes, France
- CHU NICE — Nice, France
- Institut Curie — Saint-Cloud, France
- Hopital - Foch — Suresnes, France
- Institut de Cancerologie de L'Ouest — Angers, France
Full record on ClinicalTrials.gov
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