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NCT Number: NCT06541184

Ziconotide for Non-cancer Pain by Intrathecal Administration

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.

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Key information

Conditions

Pain, Chronic Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique de la Casamance, Aubagne, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ziconotide [Prialt]

Drug

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

Primary outcomes

  1. 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

  2. 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

  3. 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)

  4. 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

  5. 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)

  6. 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)

  7. 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)

  8. 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

  9. Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: anxiety and depression disorders

    Time frame: Baseline (treatment initiation)

    Hospital Anxiety and Depression Scale (HADS) score: patient-completed questionnaire with 14 items assessing anxiety and depressive disorders

  10. Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: reasons for initiating ziconotide

    Time frame: Baseline (treatment initiation)

    Reasons for initiating ziconotide (process of medical decision)

  11. Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: planned modification of the current intrathecal treatment

    Time frame: Baseline (treatment initiation)

    Planned modification of the current intrathecal treatment

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. Describe the effect of treatment on disability

    Time frame: 3 months, 1 year and 2 years.

    Owestry disability index

  6. Describe the effect of treatment on anxiety and depression

    Time frame: 3 months, 1 year and 2 years.

    Hospital Anxiety and Depression Scale score

  7. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Anne VISBECQ

CONTACT

[email protected]

CHEVALLIER Arthur

CONTACT

[email protected]

+33 (0)7 84 15 86 75

Sponsors and collaborators

Lead sponsor

ESTEVE Pharmaceuticals SAS

Industry

Registry information

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Aug 7, 2024
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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