Ziconotide for Non-cancer Pain by Intrathecal Administration

ESTEVE Pharmaceuticals SAS

Status: Enrolling

Conditions: Pain, Chronic

Treatments: Drug: Ziconotide [Prialt]

Study type: Observational

Funder types: Industry

Identifiers

NCT06541184

ZENITH

Details and patient eligibility

About

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.

Enrollment: 85 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

85 participants in 1 patient group

Patients treated by ziconotide-based intrathecal analgesia (ITA)

Description:

Patients followed during 2 years after an initiation of ziconotide. These patients will be recruited retrospectively or prospectively.

Treatment:

Drug: Ziconotide [Prialt]