OP2C : Prialt® Observatory in Clinical Practice

Refractory Pain Clinical Trial

— OP2C  

Official title:

OP2C : Prialt® Observatory in Clinical Practice

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04321408
• Other study ID #: ICO-2019-24
• Status: Recruiting
• Start date: July 10, 2020
• Est. completion date: January 2027

Study information

• Verified date: September 2022
• Source: Institut Cancerologie de l'Ouest
• Contact: DENIS DUPOIRON, MD
• Phone: +33 241352700
• Email: denis.dupoiron[@]ico.unicancer.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Ziconotide (Prialt®) is a powerful analgesic, approved in Europe since 2005, and reserved for the intrathecal route. Ziconotide is a protein of 2500 Daltons isolated from a cone-snail: Conus Magus, acting by blocking the N-type voltage-sensitive calcium channels. Its efficacy has been proven by 3 randomized clinical trials. It is particularly effective on chronic refractory 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 became evident, especially neuropsychiatric reactions, which limited its use. This toxicity was mainly related to the administration of too high doses, especially at the start of treatment. 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 in different settings of patients with severe chronic pain requiring intrathecal analgesia.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Intractable
• Refractory Pain

Intervention

Drug:
• Ziconotide Injection
Intrathecal analgesia with Ziconotide

Locations

Country	Name	City	State
France	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	Institut Curie	Saint-Cloud
France	Hopital - Foch	Suresnes

Sponsors (2)

Lead Sponsor	Collaborator
Institut Cancerologie de l'Ouest	Esteve

Country where clinical trial is conducted

France, 

Outcome

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