DRUG
Ziconotide Injection
Intrathecal analgesia with Ziconotide
OP2C : Prialt® Observatory in Clinical Practice
Status
Recruiting
Phase
Not applicable
Enrollment
300
Locations
17
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Mar 25, 2020
Study start
Jul 10, 2020
Primary completion
Sep 2027
Study completion
Sep 2027
Results posted
Not reported
Registry updated
Aug 17, 2025
Outcomes
What the study measures.
Primary outcomes
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.
Time frame · 7 years
Indication, initial intrathecal analgesic treatment and evolution of intrathecal analgesic treatment and monitoring.
Secondary outcomes
Describe the tolerability to intrathecal ziconotide treatment
Time frame · 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
Time frame · 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
Time frame · 7 years
Time between the first and last date of administration of intrathecal ziconotide during study.
Subgroup comparative analysis
Time frame · 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
Time frame · 7 years
Responders profile according to efficacy on pain of intrathecal ziconotide treatment
Describe quality of life under ziconotide treatment
Time frame · 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
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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 locations
17 registered sites.
France · Germany · Spain. Showing up to 24 locations stored in the fast local snapshot.
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, France
University of Freiburg
Freiburg im Breisgau, Germany
Justus-Liebig-Universitat
Giessen, Germany
Jena University Hospital
Jena, Germany
Hospital Universitario Puerta Del Mar
Cadiz, Spain
Hospital General Universitario Santa Lucía
Cartagena, Spain
Hospital Universitario Virgen de las Nieves
Granada, Spain
Hospital Complexo Hospitalario de Ourense
Ourense, Spain
Hospital Universitario Virgen del Rocío
Seville, Spain
Hospital Clínico Universitario de Valencia
Valencia, Spain
Related trials
More studies on Ziconotide.
NCT IDStudyPhase / statusEnrollmentUpdated
Evaluating the Effectiveness of AIT in the Treatment of Pain Related to Pancreatic Cancer
Clinique Bizet · Pancreatic Cancer Pain · Intrathecal Analgesic
Not applicable
Not yet recruiting
40
2026-07
Intrathecal Ziconotide in Chemotherapy Induced Peripheral Neuropathy
Christian Hospital Northeast Northwest · Chemotherapy Induced Peripheral Neuropathy (CIPN)
Not applicable
Not yet recruiting
24
2026-03
Ziconotide for Non-cancer Pain by Intrathecal Administration
ESTEVE Pharmaceuticals SAS · Pain, Chronic
Not applicable
Recruiting
85
2025-02
Safety and Activity Study of Intrathecally Administered Ziconotide for Neuropathic Pain in Patients With Cancer
National Cancer Institute, Naples · Pain · Neuropathic Pain
Phase 2
Unknown
16
2023-03
Ziconotide as First-Line IDT
Albany Medical College · Neuropathic Pain
Phase 4
Completed
13
2021-01
Intrathecal Ziconotide Antalgic Efficacy for Severe Refractory Neuropathic
Hospices Civils de Lyon · Severe Refractory Neuropathic Pain · Spinal Cord Lesions
Phase 3
Unknown
44
2019-05
Patient Registry of Intrathecal Pain Management in Europe for Prialt (Ziconotide Intrathecal Infusion) and Alternative Drugs for the Management of Severe, Chronic Pain.
Eisai Limited · Pain Management · Severe Chronic Pain
Not applicable
Completed
219
2018-10
Single Shot Intrathecal Ziconotide for Painful Neuropathy or Myelopathy
Aaron Boster · Painful Myelopathy · Painful Neuropathy
Phase 4
Withdrawn
0
2018-09
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Put the record in context.
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