DRUG
Ziconotide [Prialt]
Intrathecal injection of ziconotide, using an internal pump, surgically inserted by a trained neurosurgeon or anesthesiologist, under general anesthesia.
Ziconotide for Non-cancer Pain by Intrathecal Administration
Status
Recruiting
Phase
Not applicable
Enrollment
85
Locations
14
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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) treatment has therefore been obtained in this population, for whom the drug's place is clearly documented (national and international recommendations). In contrast the management of non-cancer pain is less straightforward, partly because of the very large range of possible clinical conditions, and the utilization of ziconotide is poorly documented, mainly described in single-centre small series. Due to the lack of data, physicians are often reluctant to undertake this type of treatment, which may represent a loss of opportunity for patients. This registry aims at providing information on patients suffering from non-cancer pain refractory to standard therapy, treated by ziconotide-based intrathecal analgesia. Patients suffering from all types of non-malignant pain will be eligible for the study, including but not limited to spinal cord injury, radiculopathy, failed back surgery, diabetic neuropathy, central pain syndrome, complex regional pain syndrome, chemotherapy-induced neuropathy, fibromyalgia. The collected data will cover the first 2 years of treatment.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Aug 7, 2024
Study start
Oct 30, 2024
Primary completion
Oct 30, 2029
Study completion
Oct 30, 2029
Results posted
Not reported
Registry updated
Feb 27, 2025
Outcomes
What the study measures.
Primary outcomes
Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: demographic characteristics
Time frame · Baseline (treatment initiation)
Patient's demographic characteristics
Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: medical history
Time frame · Baseline (treatment initiation)
Relevant medical history, including history of psychiatric disorders
Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: indication for intrathecal ziconotide
Time frame · Baseline (treatment initiation)
Indication for ziconotide initiation (mechanism of pain and etiology)
Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: starting date of pain
Time frame · Baseline (treatment initiation)
Starting date of severe/disabling pain
Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: history of pain management
Time frame · Baseline (treatment initiation)
History of pain management including prior interventional techniques and current analgesic treatment (administered when decision of ziconotide treatment is made)
Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: pain intensity
Time frame · Baseline (treatment initiation)
Numerical Rating Scale score for pain (graduated from 0: absence of pain to 10: worst possible pain) analgesic treatment (administered when decision of ziconotide treatment is made)
Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: neuro-psychiatric condition
Time frame · Baseline (treatment initiation)
NPI-ES score (NeuroPsychiatric Inventory of An inventory of 12 of the most frequent symptoms of Alzheimer's disease and related disorders, assessing their frequency and severity, as well as the impact on the caregiver or professional), or score of another type or neuropsychological evaluation questionnaire)
Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: disability condition
Time frame · Baseline (treatment initiation)
Owestry disability index score: patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in 10 activities of daily living
Secondary outcomes
Describe the modalities of ziconotide therapy at ziconotide initiation
Time frame · Baseline (treatment initiation)
Ziconotide initial dose, concentration in the pump, administration in monotherapy or in combination, planned titration schedule, and concomitant non-IT analgesics.
Describe the modalities of ziconotide therapy during follow-up
Time frame · 2 years follow-up
Drugs added in or removed from the mixture ; Ziconotide posology and concentration in the pump, or ziconotide discontinuation; Evaluation of dose efficacy; Concomitant non-IT analgesics
Describe the patient's care pathway and treatment management
Time frame · 2 years follow-up
Characteristics of the physician who includes the patient; Decision to administer ziconotide in multidisciplinary meeting (MDM) and MDM members if applicable or specialty of the physician who made the decision if no MDM was organized; Type of investigations performed at inclusion and/or during follow-up (NPI-ES score or other type of neuropsychiatric evaluation), Owestry disability index, Hospital Anxiety and Depression Scale; Data on pump implantation
Describe the effect of treatment on pain evolution
Time frame · 2 years follow-up
Numerical Rating Scale (NRS) score graduated from 0 (absence of pain) to 10 (worst possible pain) collected at each visit, from inclusion to last visit
Describe the effect of treatment on disability
Time frame · 3 months, 1 year and 2 years.
Owestry disability index
Describe the effect of treatment on anxiety and depression
Time frame · 3 months, 1 year and 2 years.
Hospital Anxiety and Depression Scale score
Describe the safety and tolerability of treatment
Time frame · From treatment initiation to 2 years of follow-up
Adverse events, related to the intrathecal administration procedure or to the ziconotide
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥18 years, 2. Chronic non-cancer pain requiring interventional techniques, and eligible to ziconotide-containing intrathecal therapy, 3. 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 Criteria: 1. Contraindication to intrathecal therapy or to ziconotide 2. Any condition that may jeopardize appropriate follow-up of the treatment 3. Patient under guardianship or deprived of liberty by a judicial or administrative decision or unable to express opposition to data collection.
Study locations
14 registered sites.
France. Showing up to 24 locations stored in the fast local snapshot.
Clinique de la Casamance
Aubagne, France
Hospices Civils de Lyon
Bron, France
Polyclinique du Parc
Caen, France
CHD Vendée
La Roche-sur-Yon, France
CH Laon
Laon, France
CHU Lille
Lille, France
Clinique Mutualiste de la Porte de l'Orient
Lorient, France
Centre Léon Bérard
Lyon, France
Hopital Saint Joseph
Paris, France
CHU Poitiers
Poitiers, France
CHU Reims
Reims, France
CH Yves Le foll
Saint-Brieuc, France
CHU St Etienne
Saint-Etienne, France
IUCT Toulouse
Toulouse, France
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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
OP2C : Prialt® Observatory in Clinical Practice
Institut Cancerologie de l'Ouest · Refractory Pain
Not applicable
Recruiting
300
2025-08
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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