Actively Recruiting
OP2C : Prialt® Observatory in Clinical Practice
Led by Institut Cancerologie de l'Ouest · Updated on 2025-08-17
300
Participants Needed
17
Research Sites
372 weeks
Total Duration
On this page
Sponsors
I
Institut Cancerologie de l'Ouest
Lead Sponsor
E
Esteve
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
OP2C : Prialt® Observatory in Clinical Practice
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Contraindications to ziconotide
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Institut de Cancerologie de L'Ouest
Angers, France, 49000
Active, Not Recruiting
2
Centre Hospitalier Departemental La Roche Sur Yon
La Roche-sur-Yon, France, 85000
Active, Not Recruiting
3
Centre Leon Berard
Lyon, France, 69008
Active, Not Recruiting
4
Institut de Cancerologie de Montpellier
Montpellier, France, 34298
Suspended
5
Clinique Breteche
Nantes, France, 44000
Suspended
6
CHU NICE
Nice, France, 06003
Suspended
7
Institut Curie
Saint-Cloud, France, 92210
Suspended
8
Hopital - Foch
Suresnes, France, 92151
Active, Not Recruiting
9
University of Freiburg
Freiburg im Breisgau, Germany, 79106
Actively Recruiting
10
Justus-Liebig-Universitat
Giessen, Germany, 353902
Actively Recruiting
11
Jena University Hospital
Jena, Germany, 07747
Actively Recruiting
12
Hospital Universitario Puerta Del Mar
Cadiz, Spain, 11009
Actively Recruiting
13
Hospital General Universitario Santa Lucía
Cartagena, Spain, 30202
Actively Recruiting
14
Hospital Universitario Virgen de las Nieves
Granada, Spain, 18014
Actively Recruiting
15
Hospital Complexo Hospitalario de Ourense
Ourense, Spain, 32005
Actively Recruiting
16
Hospital Universitario Virgen del Rocío
Seville, Spain
Actively Recruiting
17
Hospital Clínico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
Research Team
D
DENIS DUPOIRON, MD
CONTACT
M
MARINE TIGREAT
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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