Ziconotide for Non-cancer Pain by Intrathecal Administration

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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.

Eligibility

Primary outcome measure(s)

• Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: demographic characteristics — Baseline (treatment initiation)
  Patient's demographic characteristics
• Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: medical history — 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 — 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 — 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 — 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 — 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 — 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 — 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
• Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: anxiety and depression disorders — Baseline (treatment initiation)
  Hospital Anxiety and Depression Scale (HADS) score: patient-completed questionnaire with 14 items assessing anxiety and depressive disorders
• Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: reasons for initiating ziconotide — Baseline (treatment initiation)
  Reasons for initiating ziconotide (process of medical decision)
• Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: planned modification of the current intrathecal treatment — Baseline (treatment initiation)
  Planned modification of the current intrathecal treatment

Trial sites (14)

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