Pain, ChronicNCT06541184
Ziconotide for Non-cancer Pain by Intrathecal Administration
An observational study of Pain, Chronic, run by ESTEVE Pharmaceuticals SAS at 14 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Chronic
- What is being tested?
- Ziconotide [Prialt]
- Type of treatment
- Injection or infusion
- How many people
- 85 participants
- Where
- 14 sitesFrance
- Study dates
- 30 Oct 2024to 30 Oct 2029
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic non-cancer pain requiring interventional techniques, and eligible to ziconotide-containing intrathecal therapy.
Who may be able to join
- Age ≥18 years,
- Chronic non-cancer pain requiring interventional techniques, and eligible to ziconotide-containing intrathecal therapy,
- 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
Who cannot join
- Contraindication to intrathecal therapy or to ziconotide
- Any condition that may jeopardize appropriate follow-up of the treatment
- Patient under guardianship or deprived of liberty by a judicial or administrative decision or unable to express opposition to data collection.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Anne VISBECQ contact
14 sites in 1 country
France14 sites, 14 recruiting
- Recruiting
Clinique de la Casamance
Aubagne
Nadjet BOUCHEMOT, MD, nadjet.bouchemot@gmail.com
Nadjet BOUCHEMOT, MD
- Recruiting
Hospices Civils de Lyon
Bron
Manon Duraffourg, MD, manon.duraffourg@chu-lyon.fr
Manon Duraffourg
- Not yet recruiting
Polyclinique du Parc
Caen
Violaine D'ANS, MD, violaine.dans@orange.fr
Violaine D'ANS, MD
- Recruiting
CHD Vendée
La Roche-sur-Yon
Yves-Marie PLUCHON, MD, yves-marie.pluchon@ght85.fr
Yves-Marie PLUCHON, MD
- Recruiting
CH Laon
Laon
Jean-Marie LE BORGNE, MD, jean-marie.leborgne@ch-laon.fr
Jean-Marie LE BORGNE, MD
- Recruiting
CHU Lille
Lille
Gilles LEBUFFE, PhD, gilles.lebuffe@chu-lille.fr
Gilles LEBUFFE, PhD
- Recruiting
Clinique Mutualiste de la Porte de l'Orient
Lorient
Marion THEOLAT, PhD, +33 2 97 64 80 00, marion.theolat@hospigrandouest.fr
- Recruiting
Centre Léon Bérard
Lyon
Olivier Renard, MD, olivier.renard@lyon.unicancer.fr
Olivier Renard, MD
- Not yet recruiting
Hopital Saint Joseph
Paris
Marie-Christine DJIAN, MD, mcdjian@ghpsj.fr
Marie-Christine DJIAN, MD
- Not yet recruiting
CHU Poitiers
Poitiers
Laure POUPIN, MD, laure.poupin@chu-poitiers.fr
Laure POUPIN, MD
- Not yet recruiting
CHU Reims
Reims
Benoit MARLIER, MD, bmarlier@chu-reims.fr
Benoit MARLIER, MD
- Recruiting
CH Yves Le foll
Saint-Brieuc
Homauon ALIPOUR, MD, homauon.alipour@armorsante.bzh
Homauon ALIPOUR, MD
- Recruiting
CHU St Etienne
Saint-Etienne
Christelle CREAC'H, PhD, +33 4 77 12 03 37, christelle.creach@chu-st-etienne.fr
- Not yet recruiting
IUCT Toulouse
Toulouse
Geneviève SALVIGNOL, PhD, +335 31 15 57 91, salvignol.Genevieve@iuct-oncopole.fr
About this study
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.
Read more
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.
- Conditions
- Pain, Chronic
- Being tested
- Ziconotide [Prialt]
- Keywords
- ziconotide, intrathecal analgesia, non-cancer pain, severe chronic pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ziconotide [Prialt]Drug
Intrathecal injection of ziconotide, using an internal pump, surgically inserted by a trained neurosurgeon or anesthesiologist, under general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ziconotide [Prialt] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: demographic characteristics
Patient's demographic characteristics
Measured: Baseline (treatment initiation)
Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: medical history
Relevant medical history, including history of psychiatric disorders
Measured: Baseline (treatment initiation)
Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: indication for intrathecal ziconotide
Indication for ziconotide initiation (mechanism of pain and etiology)
Measured: Baseline (treatment initiation)
Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: starting date of pain
Starting date of severe/disabling pain
Measured: Baseline (treatment initiation)
Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: history of pain management
History of pain management including prior interventional techniques and current analgesic treatment (administered when decision of ziconotide treatment is made)
Measured: Baseline (treatment initiation)
Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: pain intensity
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)
Measured: Baseline (treatment initiation)
Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: neuro-psychiatric condition
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)
Measured: Baseline (treatment initiation)
Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: disability condition
Owestry disability index score: patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in 10 activities of daily living
Measured: Baseline (treatment initiation)
Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: anxiety and depression disorders
Hospital Anxiety and Depression Scale (HADS) score: patient-completed questionnaire with 14 items assessing anxiety and depressive disorders
Measured: Baseline (treatment initiation)
Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: reasons for initiating ziconotide
Reasons for initiating ziconotide (process of medical decision)
Measured: Baseline (treatment initiation)
Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: planned modification of the current intrathecal treatment
Planned modification of the current intrathecal treatment
Measured: Baseline (treatment initiation)
Secondary outcomes (7)
Describe the modalities of ziconotide therapy at ziconotide initiation
Ziconotide initial dose, concentration in the pump, administration in monotherapy or in combination, planned titration schedule, and concomitant non-IT analgesics.
Measured: Baseline (treatment initiation)
Describe the modalities of ziconotide therapy during 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
Measured: 2 years follow-up
Describe the patient's care pathway and treatment management
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
Measured: 2 years follow-up
Describe the effect of treatment on pain evolution
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
Measured: 2 years follow-up
Describe the effect of treatment on disability
Owestry disability index
Measured: 3 months, 1 year and 2 years.
Describe the effect of treatment on anxiety and depression
Hospital Anxiety and Depression Scale score
Measured: 3 months, 1 year and 2 years.
Describe the safety and tolerability of treatment
Adverse events, related to the intrathecal administration procedure or to the ziconotide
Measured: From treatment initiation to 2 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start30 Oct 2024
- Primary completion30 Oct 2029 (estimated)
- Study completion30 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 85 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- ESTEVE Pharmaceuticals SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06541184
- Sponsor's protocol ID
- ZENITH
- Status last verified
- Feb 2025
- First submitted
- 2 Aug 2024
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ziconotide for Non-cancer Pain by Intrathecal Administration
- ClinicalTrials.gov ID
- NCT06541184
- Acronym / sponsor ID
- ZENITH
- Conditions
- Pain, Chronic
- Keywords
- ziconotide, intrathecal analgesia, non-cancer pain, severe chronic pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- ESTEVE Pharmaceuticals SASIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 30 Oct 2029 (estimated)
- Study completion
- 30 Oct 2029 (estimated)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated by ziconotide-based intrathecal analgesia (ITA) | – | Drug: Ziconotide [Prialt]Patients followed during 2 years after an initiation of ziconotide. These patients will be recruited retrospectively or prospectively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic non-cancer pain requiring interventional techniques, and eligible to ziconotide-containing intrathecal therapy.
Key inclusion criteria (5 listed)
- Age ≥18 years,
- Chronic non-cancer pain requiring interventional techniques, and eligible to ziconotide-containing intrathecal therapy,
- 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
Key exclusion criteria (3 listed)
- Contraindication to intrathecal therapy or to ziconotide
- Any condition that may jeopardize appropriate follow-up of the treatment
- Patient under guardianship or deprived of liberty by a judicial or administrative decision or unable to express opposition to data collection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ziconotide [Prialt]Intrathecal injection of ziconotide, using an internal pump, surgically inserted by a trained neurosurgeon or anesthesiologist, under general anesthesia. | Drug | Patients treated by ziconotide-based intrathecal analgesia (ITA) |
Primary outcome
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
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
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)
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
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)
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)
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)
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
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
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)
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
7 secondary outcomes
Describe the modalities of ziconotide therapy at ziconotide initiation
Time frame: Baseline (treatment initiation)
Describe the modalities of ziconotide therapy during follow-up
Time frame: 2 years follow-up
Describe the patient's care pathway and treatment management
Time frame: 2 years follow-up
Describe the effect of treatment on pain evolution
Time frame: 2 years follow-up
Describe the effect of treatment on disability
Time frame: 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.
Describe the safety and tolerability of treatment
Time frame: From treatment initiation to 2 years of follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anne VISBECQ contact
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Chronic, run by ESTEVE Pharmaceuticals SAS at 14 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CHEVALLIER Arthur (+33 (0)7 84 15 86 75, achevallier@esteve.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: demographic characteristics (time frame: Baseline (treatment initiation)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.