Refractory PainOP2CNCT04321408
OP2C : Prialt® Observatory in Clinical Practice
An observational study of Refractory Pain, run by Institut Cancerologie de l'Ouest at 17 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Pain
- What is being tested?
- Ziconotide Injection
- Type of treatment
- Injection or infusion
- How many people
- 300 participants
- Where
- 17 sitesin 3 countries
- Study dates
- 10 Jul 2020to Sep 2027
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with refractory pain who is initiating treatment with intrathecal analgesia containing ziconotide.
Who may be able to join
- 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.
Who cannot join
- Contraindications to ziconotide
Trial locations and contacts
17 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
17 sites in 3 countries
France8 sites
- Active, not recruiting
Institut de Cancerologie de L'Ouest
Angers, 49000
- Active, not recruiting
Centre Hospitalier Departemental La Roche Sur Yon
La Roche-sur-Yon, 85000
- Active, not recruiting
Centre Leon Berard
Lyon, 69008
- Suspended
Institut de Cancerologie de Montpellier
Montpellier, 34298
- Suspended
Clinique Breteche
Nantes, 44000
- Suspended
CHU NICE
Nice, 06003
- Suspended
Institut Curie
Saint-Cloud, 92210
- Active, not recruiting
Hopital - Foch
Suresnes, 92151
Spain6 sites, 6 recruiting
- Recruiting
Hospital Universitario Puerta Del Mar
Cadiz, 11009
Jose Manuel Trinidad Martin- Arroyo, MD, jmtrinidad80@gmail.com
Jose Manuel Trinidad Martin- Arroyo, MD
- Recruiting
Hospital General Universitario Santa Lucía
Cartagena, 30202
Maria Luz Padilla Del Rey, MD, mariluzpadilladelrey@gmail.com
Maria Luz Padilla Del Rey, MD
- Recruiting
Hospital Universitario Virgen de las Nieves
Granada, 18014
Rafael Gálvez Mateos, MD, rafaelgalvez@hotmail.com
Rafael Gálvez Mateos, MD
- Recruiting
Hospital Complexo Hospitalario de Ourense
Ourense, 32005
María Luz Cánovas Martinez, MD, luzourense2020@gmail.com
María Luz Cánovas Martinez, MD
- Recruiting
Hospital Universitario Virgen del Rocío
Seville
ISAAC PENA VERGARA, MD, isaacpv@gmail.com
ISAAC PENA VERGARA, MD
- Recruiting
Hospital Clínico Universitario de Valencia
Valencia, 46010
Juan Carlos Tornero Tornero, MD, carlostornero@gmail.com
Juan Carlos Tornero Tornero, MD
Germany3 sites, 3 recruiting
- Recruiting
University of Freiburg
Freiburg im Breisgau, 79106
Barbara Kleinmann, MD, barbara.kleinmann@uniklinik-freiburg.de
Barbara Kleinmann, MD
- Recruiting
Justus-Liebig-Universitat
Giessen, 353902
Malgorzata Kolodziej, MD, malgorzata.kolodziej@neuro.med.uni-giessen.de
Malgorzata Kolodziej, MD
- Recruiting
Jena University Hospital
Jena, 07747
Falko Schwarz, MD, Falko.Schwarz@med.uni-jena.de
Falko Schwarz, MD
About this study
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.
Read more
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.
- Conditions
- Refractory Pain
- Being tested
- Ziconotide Injection
- Keywords
- Intrathecal analgesia, Ziconotide
- Medical subject headings
- Pain, Intractable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ziconotide InjectionDrug
Also called Prialt
Intrathecal analgesia with Ziconotide
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Indication, initial intrathecal analgesic treatment and evolution of intrathecal analgesic treatment and monitoring.
Measured: 7 years
Secondary outcomes (6)
Describe the tolerability to intrathecal ziconotide treatment
Tolerability will be assessed by asking questions, clinical examination and paraclinical examinations at each visit
Measured: 7 years
Describe the efficacy on pain of intrathecal ziconotide treatment
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
Measured: 7 years
Estimate the duration of treatment according to the indication
Time between the first and last date of administration of intrathecal ziconotide during study.
Measured: 7 years
Subgroup comparative analysis
Subgroup comparative analysis will be conducted according to initial characteristics, doses course progress of ziconotide and according to efficacy and tolerability.
Measured: 7 years
Responders profile detection
Responders profile according to efficacy on pain of intrathecal ziconotide treatment
Measured: 7 years
Describe quality of life under ziconotide treatment
- 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
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start10 Jul 2020
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Refractory PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Collaborators
- Esteve
- Responsible party
- Sponsor
- Investigators
- DENIS DUPOIRON, MD, Study director, Institut de Canérologie de l'Ouest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04321408
- Sponsor's protocol ID
- ICO-2019-24
- Acronym
- OP2C
- Status last verified
- Jul 2025
- First submitted
- 23 Mar 2020
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 42189020
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OP2C : Prialt® Observatory in Clinical Practice
- ClinicalTrials.gov ID
- NCT04321408
- Acronym / sponsor ID
- OP2C / ICO-2019-24
- Conditions
- Refractory Pain
- Keywords
- Intrathecal analgesia, Ziconotide
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Collaborators
- Esteve
- Study start
- 10 Jul 2020 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 25 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with refractory pain who is initiating treatment with intrathecal analgesia containing ziconotide.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Contraindications to ziconotide
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ziconotide InjectionAlso: PrialtIntrathecal analgesia with Ziconotide | Drug | – |
Primary outcome
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Derived from this study: PubMed 42189020Dupoiron 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
DENIS DUPOIRON, MD study director
Institut de Canérologie de l'Ouest
17 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Refractory Pain, run by Institut Cancerologie de l'Ouest at 17 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France, Spain, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact DENIS DUPOIRON, MD (+33 241352700 ext. +33, denis.dupoiron@ico.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04321408, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025; AzTrials last refreshed its copy on 30 Oct 2026.