Clinical trial NCT04321408: OP2C : Prialt® Observatory in Clinical Practice
Official title: OP2C : Prialt® Observatory in Clinical Practice
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Refractory Pain
Keywords: Intrathecal analgesia
Ziconotide
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
Collaborators: name: Esteve
First posted: 2020-03-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with refractory pain who is initiating treatment with intrathecal analgesia containing ziconotide.

Brief 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.

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.


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

Primary outcomes:
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.
timeFrame: 7 years
Secondary outcomes:
measure: Describe the tolerability to intrathecal ziconotide treatment
timeFrame: 7 years
measure: Describe the efficacy on pain of intrathecal ziconotide treatment
timeFrame: 7 years
measure: Estimate the duration of treatment according to the indication
timeFrame: 7 years
measure: Subgroup comparative analysis
timeFrame: 7 years
measure: Responders profile detection
timeFrame: 7 years
measure: Describe quality of life under ziconotide treatment
timeFrame: 7 years
Other outcomes:
Locations:
city: Angers
country: France
facility: Institut de Cancerologie de L'Ouest
city: La Roche-sur-Yon
country: France
facility: Centre Hospitalier Departemental La Roche Sur Yon
city: Lyon
country: France
facility: Centre Leon Berard
city: Montpellier
country: France
facility: Institut de Cancerologie de Montpellier
city: Nantes
country: France
facility: Clinique Breteche
city: Nice
country: France
facility: CHU NICE
city: Saint-Cloud
country: France
facility: Institut Curie
city: Suresnes
country: France
facility: Hopital - Foch
city: Freiburg
country: Germany
facility: University of Freiburg
city: Gießen
country: Germany
facility: Justus-Liebig-Universitat
city: Jena
country: Germany
facility: Jena University Hospital
city: Cadiz
country: Spain
facility: Hospital Universitario Puerta Del Mar
city: Cartagena
country: Spain
facility: Hospital General Universitario Santa Lucía
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Ourense
country: Spain
facility: Hospital Complexo Hospitalario de Ourense
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
Study officials:
affiliation: Institut de Canérologie de l'Ouest
name: DENIS DUPOIRON, MD
role: STUDY_DIRECTOR
References: