OP2C : Prialt® Observatory in Clinical Practice
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ziconotide Injection.
- Who it may be relevant to
- Registry conditions: Refractory Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France, Germany, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Ziconotide Injection
Intrathecal analgesia with Ziconotide
Primary outcome measures
- Describe the practical methods of using intrathecal treatments containing ziconotide: indication, initial intrathecal analgesic treatment and evolution of intrathecal analgesic treatment, efficacy and safety in the real clinical practice and monitoring. [Time frame: 7 years]
Secondary outcome measures (6)
- Describe the tolerability to intrathecal ziconotide treatment [Time frame: 7 years]
- Describe the efficacy on pain of intrathecal ziconotide treatment [Time frame: 7 years]
- Estimate the duration of treatment according to the indication [Time frame: 7 years]
- Subgroup comparative analysis [Time frame: 7 years]
- Responders profile detection [Time frame: 7 years]
- Describe quality of life under ziconotide treatment [Time frame: 7 years]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 8 centers
- Institut de Cancerologie de L'Ouest — Angers
- Centre Hospitalier Departemental La Roche Sur Yon — La Roche-sur-Yon
- Centre Leon Berard — Lyon
- Institut de Cancerologie de Montpellier — Montpellier
- Clinique Breteche — Nantes
- CHU NICE — Nice
- Institut Curie — Saint-Cloud
- Hopital - Foch — Suresnes
Spain · 6 centers
- Hospital Universitario Puerta Del Mar — Cadiz
- Hospital General Universitario Santa Lucía — Cartagena
- Hospital Universitario Virgen de las Nieves — Granada
- Hospital Complexo Hospitalario de Ourense — Ourense
- Hospital Universitario Virgen del Rocío — Seville
- Hospital Clínico Universitario de Valencia — Valencia
Germany · 3 centers
- University of Freiburg — Freiburg im Breisgau
- Justus-Liebig-Universitat — Giessen
- Jena University Hospital — Jena
Publications
- Dupoiron D, Chvetzoff G, Seegers V, Ouerchefani N, Pluchon YM, Julienne A, Jubier-Hamon S, Bienfait F. Real-Life Data on Ziconotide-Based Intrathecal Therapy in Patients With Cancer Pain: Interim Analysis of the Observational Practice in Clinics Registry. Neuromodulation. 2026 Apr 21:S1094-7159(26)00086-3. doi: 10.1016/j.neurom.2026.04.006. Online ahead of print. PMID 42189020
Identifiers
NCT: NCT04321408 · ICO-2019-24