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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04321408
Other study ID # ICO-2019-24
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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