Ziconotide for Non-cancer Pain by Intrathecal Administration

February 25, 2025 updated by: ESTEVE Pharmaceuticals SAS

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

85

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Aubagne, France
        • Recruiting
        • Clinique de la Casamance
        • Contact:
        • Contact:
          • Nadjet BOUCHEMOT, MD
      • Bron, France
      • Caen, France
        • Not yet recruiting
        • Polyclinique du Parc
        • Contact:
        • Contact:
          • Violaine D'ANS, MD
      • La Roche-sur-Yon, France
      • Laon, France
      • Lille, France
      • Lorient, France
      • Lyon, France
      • Paris, France
        • Not yet recruiting
        • Hopital Saint Joseph
        • Contact:
        • Contact:
          • Marie-Christine DJIAN, MD
      • Poitiers, France
      • Reims, France
        • Not yet recruiting
        • Chu Reims
        • Contact:
        • Contact:
          • Benoit MARLIER, MD
      • Saint-Brieuc, France
      • St Etienne, France
      • Toulouse, France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with chronic non-cancer pain requiring interventional techniques, and eligible to ziconotide-containing intrathecal therapy.

Description

Inclusion Criteria:

  1. Age ≥18 years,
  2. Chronic non-cancer pain requiring interventional techniques, and eligible to ziconotide-containing intrathecal therapy,
  3. 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:

  1. Contraindication to intrathecal therapy or to ziconotide
  2. Any condition that may jeopardize appropriate follow-up of the treatment
  3. Patient under guardianship or deprived of liberty by a judicial or administrative decision or unable to express opposition to data collection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients treated by ziconotide-based intrathecal analgesia (ITA)
Patients followed during 2 years after an initiation of ziconotide. These patients will be recruited retrospectively or prospectively.
Drug: Ziconotide [Prialt]
Intrathecal injection of ziconotide, using an internal pump, surgically inserted by a trained neurosurgeon or anesthesiologist, under general anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline (treatment initiation)
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
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)
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
Time Frame: Baseline (treatment initiation)
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
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)
Baseline (treatment initiation)
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)
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)
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
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
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)
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
Time Frame: Baseline (treatment initiation)
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
Time Frame: Baseline (treatment initiation)
Planned modification of the current intrathecal treatment
Baseline (treatment initiation)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (treatment initiation)
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
2 years follow-up
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
2 years follow-up
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
2 years follow-up
Describe the effect of treatment on disability
Time Frame: 3 months, 1 year and 2 years.
Owestry disability index
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.
Hospital Anxiety and Depression Scale score
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
Adverse events, related to the intrathecal administration procedure or to the ziconotide
From treatment initiation to 2 years of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ESTEVE Pharmaceuticals SAS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2024

Primary Completion (Estimated)

October 30, 2029

Study Completion (Estimated)

October 30, 2029

Study Registration Dates

First Submitted

August 2, 2024

First Submitted That Met QC Criteria

August 2, 2024

First Posted (Actual)

August 7, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 25, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZENITH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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