Status:
RECRUITING
Ziconotide for Non-cancer Pain by Intrathecal Administration
Lead Sponsor:
ESTEVE Pharmaceuticals SAS
Conditions:
Pain, Chronic
Eligibility:
All Genders
18+ years
Brief Summary
Although ziconotide's marketing authorization does not restrict its use to a given type of pain, the drug has been used mainly in cancer patients. Most data on ziconotide-based intrathecal (IT) treatm...
Eligibility Criteria
Inclusion
- Age ≥18 years,
- Chronic non-cancer pain requiring interventional techniques, and eligible to ziconotide-containing intrathecal therapy,
- Having received information on and not opposed to data collection,
- Inclusion criteria specific for the retrospective cohort:
- Currently treated by ziconotide-based ITA according to SmPC whatever the duration of treatment
- Inclusion criteria specific for the prospective cohort:
- Naïve of ITA and candidate to ziconotide-based ITA or already treated by IT route without ziconotide, scheduled for addition of ziconotide in the pump
Exclusion
- Contraindication to intrathecal therapy or to ziconotide
- Any condition that may jeopardize appropriate follow-up of the treatment
- Patient under guardianship or deprived of liberty by a judicial or administrative decision or unable to express opposition to data collection.
Key Trial Info
Start Date :
October 30 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 30 2029
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT06541184
Start Date
October 30 2024
End Date
October 30 2029
Last Update
February 27 2025
Active Locations (14)
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1
Clinique de la Casamance
Aubagne, France
2
Hospices Civils de Lyon
Bron, France
3
Polyclinique du Parc
Caen, France
4
CHD Vendée
La Roche-sur-Yon, France