Ziconotide for Non-cancer Pain by Intrathecal Administration
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ziconotide [Prialt].
- Who it may be relevant to
- Registry conditions: Pain, Chronic. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug Ziconotide [Prialt]
Intrathecal injection of ziconotide, using an internal pump, surgically inserted by a trained neurosurgeon or anesthesiologist, under general anesthesia.
Primary outcome measures
- Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: demographic characteristics [Time frame: Baseline (treatment initiation)]
- Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: medical history [Time frame: Baseline (treatment initiation)]
- Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: indication for intrathecal ziconotide [Time frame: Baseline (treatment initiation)]
- Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: starting date of pain [Time frame: Baseline (treatment initiation)]
- Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: history of pain management [Time frame: Baseline (treatment initiation)]
- Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: pain intensity [Time frame: Baseline (treatment initiation)]
- Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: neuro-psychiatric condition [Time frame: Baseline (treatment initiation)]
- Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: disability condition [Time frame: Baseline (treatment initiation)]
- Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: anxiety and depression disorders [Time frame: Baseline (treatment initiation)]
- Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: reasons for initiating ziconotide [Time frame: Baseline (treatment initiation)]
Secondary outcome measures (7)
- Describe the modalities of ziconotide therapy at ziconotide initiation [Time frame: Baseline (treatment initiation)]
- Describe the modalities of ziconotide therapy during follow-up [Time frame: 2 years follow-up]
- Describe the patient's care pathway and treatment management [Time frame: 2 years follow-up]
- Describe the effect of treatment on pain evolution [Time frame: 2 years follow-up]
- Describe the effect of treatment on disability [Time frame: 3 months, 1 year and 2 years.]
- Describe the effect of treatment on anxiety and depression [Time frame: 3 months, 1 year and 2 years.]
- Describe the safety and tolerability of treatment [Time frame: From treatment initiation to 2 years of follow-up]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
France · 14 centers
- Clinique de la Casamance — Aubagne
- Hospices Civils de Lyon — Bron
- Polyclinique du Parc — Caen
- CHD Vendée — La Roche-sur-Yon
- CH Laon — Laon
- CHU Lille — Lille
- Clinique Mutualiste de la Porte de l'Orient — Lorient
- Centre Léon Bérard — Lyon
- … and 6 more centers
Identifiers
NCT: NCT06541184 · ZENITH