OP2C : Prialt® Observatory in Clinical Practice

Recruiting

• Conditions: Refractory Pain

• Registration Number: NCT04321408
• Lead Sponsor: Institut Cancerologie de l'Ouest

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-23
• Study First Submitted QC: 2020-03-23
• Study First Posted: 2020-03-25
• Study Start: 2020-07-10
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-17
• Last Update Posted: 2024-07-18
• Primary Completion: 2027-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	7 years	Indication, initial intrathecal analgesic treatment and evolution of intrathecal analgesic treatment and monitoring.

Secondary Outcome Measures

Name	Time	Method
Describe the tolerability to intrathecal ziconotide treatment	7 years	Tolerability will be assessed by asking questions, clinical examination and paraclinical examinations at each visit
Describe the efficacy on pain of intrathecal ziconotide treatment	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
Estimate the duration of treatment according to the indication	7 years	Time between the first and last date of administration of intrathecal ziconotide during study.
Subgroup comparative analysis	7 years	Subgroup comparative analysis will be conducted according to initial characteristics, doses course progress of ziconotide and according to efficacy and tolerability.
Responders profile detection	7 years	Responders profile according to efficacy on pain of intrathecal ziconotide treatment
Describe quality of life under ziconotide treatment	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

Trial Locations

Locations (17)

Institut de Cancerologie de L'Ouest; 🇫🇷 Angers, France

Centre Hospitalier Departemental La Roche Sur Yon; 🇫🇷 La Roche-sur-Yon, France

Centre Leon Berard; 🇫🇷 Lyon, France

Institut de Cancerologie de Montpellier; 🇫🇷 Montpellier, France

Clinique Breteche; 🇫🇷 Nantes, France

CHU NICE; 🇫🇷 Nice, France

Hopital - Foch; 🇫🇷 Suresnes, France

Institut Curie; 🇫🇷 Saint-Cloud, France

University of Freiburg; 🇩🇪 Freiburg, Germany

Justus-Liebig-Universitat; 🇩🇪 Gießen, Germany

Jena University Hospital; 🇩🇪 Jena, Germany

Hospital Universitario Virgen de las Nieves; 🇪🇸 Granada, Spain

Hospital Complexo Hospitalario de Ourense; 🇪🇸 Ourense, Spain

Hospital General Universitario Santa Lucía; 🇪🇸 Cartagena, Spain

Hospital Clínico Universitario de Valencia; 🇪🇸 Valencia, Spain

Hospital Universitario Virgen del Rocío; 🇪🇸 Sevilla, Spain

Hospital Universitario Puerta Del Mar; 🇪🇸 Cadiz, Spain