Ziconotide for Non-cancer Pain by Intrathecal Administration

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

85 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-30

Study Completion Date

2029-10-30

Brief Summary

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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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Detailed Description

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Conditions

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Pain, Chronic

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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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.

Ziconotide [Prialt]

Intervention Type DRUG

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

Interventions

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Ziconotide [Prialt]

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

Intervention Type DRUG

Eligibility Criteria

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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,

Currently treated by ziconotide-based ITA according to SmPC whatever the duration of treatment

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No