OP2C : Prialt® Observatory in Clinical Practice (OP2C)

August 13, 2025 updated by: Institut Cancerologie de l'Ouest

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Angers, France, 49000
        • Active, not recruiting
        • Institut de Cancérologie de l'Ouest
      • La Roche-sur-Yon, France, 85000
        • Active, not recruiting
        • Centre hospitalier départemental La Roche sur Yon
      • Lyon, France, 69008
        • Active, not recruiting
        • Centre Léon Bérard
      • Montpellier, France, 34298
        • Suspended
        • Institut de Cancérologie de Montpellier
      • Nantes, France, 44000
        • Suspended
        • Clinique Brétéché
      • Nice, France, 06003
        • Suspended
        • CHU Nice
      • Saint-Cloud, France, 92210
        • Suspended
        • Institut Curie
      • Suresnes, France, 92151
        • Active, not recruiting
        • Hopital - Foch
  • Germany
  • Spain
      • Cadiz, Spain, 11009
        • Recruiting
        • Hospital Universitario Puerta del Mar
        • Contact:
        • Principal Investigator:
          • Jose Manuel Trinidad Martin- Arroyo, MD
      • Cartagena, Spain, 30202
        • Recruiting
        • Hospital General Universitario Santa Lucía
        • Principal Investigator:
          • Maria Luz Padilla Del Rey, MD
        • Contact:
      • Granada, Spain, 18014
        • Recruiting
        • Hospital Universitario Virgen de las Nieves
        • Contact:
        • Principal Investigator:
          • Rafael Gálvez Mateos, MD
      • Ourense, Spain, 32005
        • Recruiting
        • Hospital Complexo Hospitalario de Ourense
        • Contact:
        • Principal Investigator:
          • María Luz Cánovas Martinez, MD
      • Sevilla, Spain
        • Recruiting
        • Hospital Universitario Virgen del Rocio
        • Contact:
        • Principal Investigator:
          • ISAAC PENA VERGARA, MD
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clínico Universitario de Valencia
        • Contact:
        • Principal Investigator:
          • Juan Carlos Tornero Tornero, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with refractory pain who is initiating treatment with intrathecal analgesia containing ziconotide.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Indication, initial intrathecal analgesic treatment and evolution of intrathecal analgesic treatment and monitoring.
7 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describe the tolerability to intrathecal ziconotide treatment
Time Frame: 7 years
Tolerability will be assessed by asking questions, clinical examination and paraclinical examinations at each visit
7 years
Describe the efficacy on pain of intrathecal ziconotide treatment
Time Frame: 7 years
The efficacy of the analgesic treatment is measured based on the numeric pain rating scale (0 to 10) at start of Ziconotide, 1, 3, 6, 12 months, and every 12 months thereafter
7 years
Estimate the duration of treatment according to the indication
Time Frame: 7 years
Time between the first and last date of administration of intrathecal ziconotide during study.
7 years
Subgroup comparative analysis
Time Frame: 7 years
Subgroup comparative analysis will be conducted according to initial characteristics, doses course progress of ziconotide and according to efficacy and tolerability.
7 years
Responders profile detection
Time Frame: 7 years
Responders profile according to efficacy on pain of intrathecal ziconotide treatment
7 years
Describe quality of life under ziconotide treatment
Time Frame: 7 years
f) The Quality of life will be assessed by EQ5D-5L questionnaires under intrathecal ziconotide treatment, at 1, 3, 6, 12 months, and every 12 months thereafter until the registry remains open
7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Cancerologie de l'Ouest

Collaborators

Esteve

Investigators

  • Study Director: DENIS DUPOIRON, MD, Institut de Canérologie de l'Ouest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2020

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

March 23, 2020

First Submitted That Met QC Criteria

March 23, 2020

First Posted (Actual)

March 25, 2020

Study Record Updates

Last Update Posted (Actual)

August 17, 2025

Last Update Submitted That Met QC Criteria

August 13, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICO-2019-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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