Ziconotide for Non-cancer Pain by Intrathecal Administration
NCT Number: NCT06541184
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pain, Chronic
Interventions: DRUG: Ziconotide [Prialt]
Sponsor: ESTEVE Pharmaceuticals SAS
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 85
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-15
Completion Date: 2029-09-15
Locations: 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|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

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) 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.

Primary Outcome Measures: Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: demographic characteristics, Patient's demographic characteristics, Baseline (treatment initiation)|Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: medical history, Relevant medical history, including history of psychiatric disorders, Baseline (treatment initiation)|Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: indication for intrathecal ziconotide, Indication for ziconotide initiation (mechanism of pain and etiology), Baseline (treatment initiation)|Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: starting date of pain, Starting date of severe/disabling pain, Baseline (treatment initiation)|Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: history of pain management, History of pain management including prior interventional techniques and current analgesic treatment (administered when decision of ziconotide treatment is made), Baseline (treatment initiation)|Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: pain intensity, 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), Baseline (treatment initiation)|Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: neuro-psychiatric condition, 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), Baseline (treatment initiation)|Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: disability condition, Owestry disability index score: patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in 10 activities of daily living, Baseline (treatment initiation)|Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: anxiety and depression disorders, Hospital Anxiety and Depression Scale (HADS) score: patient-completed questionnaire with 14 items assessing anxiety and depressive disorders, Baseline (treatment initiation)|Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: reasons for initiating ziconotide, Reasons for initiating ziconotide (process of medical decision), Baseline (treatment initiation)|Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: planned modification of the current intrathecal treatment, Planned modification of the current intrathecal treatment, Baseline (treatment initiation)
Secondary Outcome Measures: Describe the modalities of ziconotide therapy at ziconotide initiation, Ziconotide initial dose, concentration in the pump, administration in monotherapy or in combination, planned titration schedule, and concomitant non-IT analgesics., Baseline (treatment initiation)|Describe the modalities of ziconotide therapy during 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, 2 years follow-up|Describe the patient's care pathway and treatment management, 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, 2 years follow-up|Describe the effect of treatment on pain evolution, 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, 2 years follow-up|Describe the effect of treatment on disability, Owestry disability index, 3 months, 1 year and 2 years.|Describe the effect of treatment on anxiety and depression, Hospital Anxiety and Depression Scale score, 3 months, 1 year and 2 years.|Describe the safety and tolerability of treatment, Adverse events, related to the intrathecal administration procedure or to the ziconotide, From treatment initiation to 2 years of follow-up