Clinical trial NCT06541184: Ziconotide for Non-cancer Pain by Intrathecal Administration
Official title: Ziconotide for Non-cancer Pain by Intrathecal Administration
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pain, Chronic
Keywords: ziconotide
intrathecal analgesia
non-cancer pain
severe chronic pain
Lead sponsor: ESTEVE Pharmaceuticals SAS
Sponsor class: INDUSTRY
First posted: 2024-08-07
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic non-cancer pain requiring interventional techniques, and eligible to ziconotide-containing intrathecal therapy.

Brief 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 criteria: 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.

Primary outcomes:
measure: Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: demographic characteristics
timeFrame: Baseline (treatment initiation)
measure: Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: medical history
timeFrame: Baseline (treatment initiation)
measure: Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: indication for intrathecal ziconotide
timeFrame: Baseline (treatment initiation)
measure: Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: starting date of pain
timeFrame: Baseline (treatment initiation)
measure: Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: history of pain management
timeFrame: Baseline (treatment initiation)
measure: Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: pain intensity
timeFrame: Baseline (treatment initiation)
measure: Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: neuro-psychiatric condition
timeFrame: Baseline (treatment initiation)
measure: Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: disability condition
timeFrame: Baseline (treatment initiation)
measure: Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: anxiety and depression disorders
timeFrame: Baseline (treatment initiation)
measure: Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: reasons for initiating ziconotide
timeFrame: Baseline (treatment initiation)
measure: Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: planned modification of the current intrathecal treatment
timeFrame: Baseline (treatment initiation)
Secondary outcomes:
measure: Describe the modalities of ziconotide therapy at ziconotide initiation
timeFrame: Baseline (treatment initiation)
measure: Describe the modalities of ziconotide therapy during follow-up
timeFrame: 2 years follow-up
measure: Describe the patient's care pathway and treatment management
timeFrame: 2 years follow-up
measure: Describe the effect of treatment on pain evolution
timeFrame: 2 years follow-up
measure: Describe the effect of treatment on disability
timeFrame: 3 months, 1 year and 2 years.
measure: Describe the effect of treatment on anxiety and depression
timeFrame: 3 months, 1 year and 2 years.
measure: Describe the safety and tolerability of treatment
timeFrame: From treatment initiation to 2 years of follow-up
Other outcomes:
Locations:
city: Aubagne
country: France
facility: Clinique de la Casamance
city: Bron
country: France
facility: Hospices Civils de Lyon
city: Caen
country: France
facility: Polyclinique du Parc
city: La Roche-sur-Yon
country: France
facility: CHD Vendée
city: Laon
country: France
facility: CH Laon
city: Lille
country: France
facility: CHU Lille
city: Lorient
country: France
facility: Clinique Mutualiste de la Porte de l'Orient
city: Lyon
country: France
facility: Centre Léon Bérard
city: Paris
country: France
facility: Hopital Saint Joseph
city: Poitiers
country: France
facility: CHU Poitiers
city: Reims
country: France
facility: CHU Reims
city: Saint-Brieuc
country: France
facility: CH Yves Le foll
city: St Etienne
country: France
facility: CHU St Etienne
city: Toulouse
country: France
facility: IUCT Toulouse
Study officials:
References: