Trial Title:
Ziconotide for Non-cancer Pain by Intrathecal Administration
NCT ID:
NCT06541184
Condition:
Pain, Chronic
Conditions: Official terms:
Chronic Pain
Ziconotide
Conditions: Keywords:
ziconotide
intrathecal analgesia
non-cancer pain
severe chronic pain
Study type:
Observational [Patient Registry]
Overall status:
Not yet recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Drug
Intervention name:
Ziconotide [Prialt]
Description:
Intrathecal injection of ziconotide, using an internal pump, surgically inserted by a
trained neurosurgeon or anesthesiologist, under general anesthesia.
Arm group label:
Patients treated by ziconotide-based intrathecal analgesia (ITA)
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.
Criteria for eligibility:
Study pop:
Patients with chronic non-cancer pain requiring interventional techniques, and eligible
to ziconotide-containing intrathecal therapy.
Sampling method:
Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Clinique de la Casamance
Address:
City:
Aubagne
Country:
France
Contact:
Last name:
Nadjet BOUCHEMOT, MD
Email:
nadjet.bouchemot@gmail.com
Investigator:
Last name:
Nadjet BOUCHEMOT, MD
Email:
Principal Investigator
Facility:
Name:
Hospices Civils de Lyon
Address:
City:
Bron
Country:
France
Contact:
Last name:
Manon Duraffourg, MD
Email:
manon.duraffourg@chu-lyon.fr
Investigator:
Last name:
Manon Duraffourg
Email:
Principal Investigator
Facility:
Name:
Polyclinique du Parc
Address:
City:
Caen
Country:
France
Contact:
Last name:
Violaine D'ANS, MD
Email:
violaine.dans@orange.fr
Investigator:
Last name:
Violaine D'ANS, MD
Email:
Principal Investigator
Facility:
Name:
CHD Vendée
Address:
City:
La Roche-sur-Yon
Country:
France
Contact:
Last name:
Yves-Marie PLUCHON, MD
Email:
yves-marie.pluchon@ght85.fr
Investigator:
Last name:
Yves-Marie PLUCHON, MD
Email:
Principal Investigator
Facility:
Name:
CH Laon
Address:
City:
Laon
Country:
France
Contact:
Last name:
Jean-Marie LE BORGNE, MD
Email:
jean-marie.leborgne@ch-laon.fr
Investigator:
Last name:
Jean-Marie LE BORGNE, MD
Email:
Principal Investigator
Facility:
Name:
CHU Lille
Address:
City:
Lille
Country:
France
Contact:
Last name:
Gilles LEBUFFE, PhD
Email:
gilles.lebuffe@chu-lille.fr
Investigator:
Last name:
Gilles LEBUFFE, PhD
Email:
Principal Investigator
Facility:
Name:
Centre Léon Bérard
Address:
City:
Lyon
Country:
France
Contact:
Last name:
Olivier Renard, MD
Email:
olivier.renard@lyon.unicancer.fr
Investigator:
Last name:
Olivier Renard, MD
Email:
Principal Investigator
Facility:
Name:
Hopital Saint Joseph
Address:
City:
Paris
Country:
France
Contact:
Last name:
Marie-Christine DJIAN, MD
Email:
mcdjian@ghpsj.fr
Investigator:
Last name:
Marie-Christine DJIAN, MD
Email:
Principal Investigator
Facility:
Name:
CHU Poitiers
Address:
City:
Poitiers
Country:
France
Contact:
Last name:
Laure POUPIN, MD
Email:
laure.poupin@chu-poitiers.fr
Investigator:
Last name:
Laure POUPIN, MD
Email:
Principal Investigator
Facility:
Name:
CHU Reims
Address:
City:
Reims
Country:
France
Contact:
Last name:
Benoit MARLIER, MD
Email:
bmarlier@chu-reims.fr
Investigator:
Last name:
Benoit MARLIER, MD
Email:
Principal Investigator
Facility:
Name:
CH Yves Le foll
Address:
City:
Saint-Brieuc
Country:
France
Contact:
Last name:
Homauon ALIPOUR, MD
Email:
homauon.alipour@armorsante.bzh
Investigator:
Last name:
Homauon ALIPOUR, MD
Email:
Principal Investigator
Start date:
September 15, 2024
Completion date:
September 15, 2029
Lead sponsor:
Agency:
ESTEVE Pharmaceuticals SAS
Agency class:
Industry
Source:
ESTEVE Pharmaceuticals SAS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06541184
