Ziconotide for Non-cancer Pain by Intrathecal Administration

Обзор

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.

Вмешательства

• Препарат Ziconotide [Prialt]
  Intrathecal injection of ziconotide, using an internal pump, surgically inserted by a trained neurosurgeon or anesthesiologist, under general anesthesia.

Первичные конечные точки

• Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: demographic characteristics [Срок оценки: Baseline (treatment initiation)]
• Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: medical history [Срок оценки: Baseline (treatment initiation)]
• Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: indication for intrathecal ziconotide [Срок оценки: Baseline (treatment initiation)]
• Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: starting date of pain [Срок оценки: Baseline (treatment initiation)]
• Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: history of pain management [Срок оценки: Baseline (treatment initiation)]
• Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: pain intensity [Срок оценки: Baseline (treatment initiation)]
• Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: neuro-psychiatric condition [Срок оценки: Baseline (treatment initiation)]
• Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: disability condition [Срок оценки: Baseline (treatment initiation)]
• Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: anxiety and depression disorders [Срок оценки: Baseline (treatment initiation)]
• Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: reasons for initiating ziconotide [Срок оценки: Baseline (treatment initiation)]

Вторичные конечные точки (7)

• Describe the modalities of ziconotide therapy at ziconotide initiation [Срок оценки: Baseline (treatment initiation)]
• Describe the modalities of ziconotide therapy during follow-up [Срок оценки: 2 years follow-up]
• Describe the patient's care pathway and treatment management [Срок оценки: 2 years follow-up]
• Describe the effect of treatment on pain evolution [Срок оценки: 2 years follow-up]
• Describe the effect of treatment on disability [Срок оценки: 3 months, 1 year and 2 years.]
• Describe the effect of treatment on anxiety and depression [Срок оценки: 3 months, 1 year and 2 years.]
• Describe the safety and tolerability of treatment [Срок оценки: From treatment initiation to 2 years of follow-up]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Франция · 14 центров

• 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
• … и ещё 6 центров

Идентификаторы

NCT: NCT06541184 · ZENITH

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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