Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Esteve | OTHER |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ziconotide Injection | Drug | Intrathecal analgesia with Ziconotide |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Describe the tolerability to intrathecal ziconotide treatment | Tolerability will be assessed by asking questions, clinical examination and paraclinical examinations at each visit | 7 years |
| Describe the efficacy on pain of intrathecal ziconotide treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with refractory pain who is initiating treatment with intrathecal analgesia containing ziconotide.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| DENIS DUPOIRON, MD | Contact | +33 241352700 | +33 | denis.dupoiron@ico.unicancer.fr |
| MARINE TIGREAT | Contact | +33 240679878 | +33 | marine.tigreat@ico.unicancer.fr |
| Name | Affiliation | Role |
|---|---|---|
| DENIS DUPOIRON, MD | Institut de Canérologie de l'Ouest | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Cancerologie de L'Ouest | Active, not recruiting | Angers | 49000 | France | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42189020 | Derived | Dupoiron D, Chvetzoff G, Seegers V, Ouerchefani N, Pluchon YM, Julienne A, Jubier-Hamon S, Bienfait F. Real-Life Data on Ziconotide-Based Intrathecal Therapy in Patients With Cancer Pain: Interim Analysis of the Observational Practice in Clinics Registry. Neuromodulation. 2026 Apr 21:S1094-7159(26)00086-3. doi: 10.1016/j.neurom.2026.04.006. Online ahead of print. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010148 | Pain, Intractable |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C078452 | ziconotide |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| 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 |
| 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 |
| Responders profile detection | Responders profile according to efficacy on pain of intrathecal ziconotide treatment | 7 years |
| 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 |
| Centre Hospitalier Departemental La Roche Sur Yon |
| Active, not recruiting |
| La Roche-sur-Yon |
| 85000 |
| France |
| Centre Leon Berard | Active, not recruiting | Lyon | 69008 | France |
| Institut de Cancerologie de Montpellier | Suspended | Montpellier | 34298 | France |
| Clinique Breteche | Suspended | Nantes | 44000 | France |
| CHU NICE | Suspended | Nice | 06003 | France |
| Institut Curie | Suspended | Saint-Cloud | 92210 | France |
| Hopital - Foch | Active, not recruiting | Suresnes | 92151 | France |
| University of Freiburg | Recruiting | Freiburg im Breisgau | 79106 | Germany |
|
| Justus-Liebig-Universitat | Recruiting | Giessen | 353902 | Germany |
|
| Jena University Hospital | Recruiting | Jena | 07747 | Germany |
|
| Hospital Universitario Puerta Del Mar | Recruiting | Cadiz | 11009 | Spain |
|
| Hospital General Universitario Santa Lucía | Recruiting | Cartagena | 30202 | Spain |
|
| Hospital Universitario Virgen de las Nieves | Recruiting | Granada | 18014 | Spain |
|
| Hospital Complexo Hospitalario de Ourense | Recruiting | Ourense | 32005 | Spain |
|
| Hospital Universitario Virgen del Rocío | Recruiting | Seville | Spain |
|
| Hospital Clínico Universitario de Valencia | Recruiting | Valencia | 46010 | Spain |
|