Ziconotide for Non-cancer Pain by Intrathecal Administration

NCT06541184 | Recruiting

• 1 other identifier: ZENITH
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 14

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.

Conditions

Pain, Chronic

Keywords

ziconotide; intrathecal analgesia; non-cancer pain; severe chronic pain

Outcome Measures

Primary Outcomes (11)

• Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: demographic characteristics

  Patient's demographic characteristics

  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

  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)

  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

  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)

  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)

  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)

  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

  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

  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)

  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

  Baseline (treatment initiation)

Secondary Outcomes (7)

• Describe the modalities of ziconotide therapy at ziconotide initiation

  Baseline (treatment initiation)

• Describe the modalities of ziconotide therapy during follow-up

  2 years follow-up

• Describe the patient's care pathway and treatment management

  2 years follow-up

• Describe the effect of treatment on pain evolution

  2 years follow-up

• Describe the effect of treatment on disability

  3 months, 1 year and 2 years.

Study Arms (1)

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.

Drug: Ziconotide [Prialt]

Interventions

Ziconotide [Prialt] DRUG

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

Patients treated by ziconotide-based intrathecal analgesia (ITA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with chronic non-cancer pain requiring interventional techniques, and eligible to ziconotide-containing intrathecal therapy.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• ESTEVE Pharmaceuticals SAS: lead

Study Sites (14)

Clinique de la Casamance

Aubagne, France

RECRUITING

Hospices Civils de Lyon

Bron, France

RECRUITING

Polyclinique du Parc

Caen, France

NOT YET RECRUITING

CHD Vendée

La Roche-sur-Yon, France

RECRUITING

CH Laon

Laon, France

RECRUITING

CHU Lille

Lille, France

RECRUITING

Clinique Mutualiste de la Porte de l'Orient

Lorient, France

RECRUITING

Centre Léon Bérard

Lyon, France

RECRUITING

Hopital Saint Joseph

Paris, France

NOT YET RECRUITING

CHU Poitiers

Poitiers, France

NOT YET RECRUITING

CHU Reims

Reims, France

NOT YET RECRUITING

CH Yves Le foll

Saint-Brieuc, France

RECRUITING

CHU St Etienne

Saint-Etienne, France

RECRUITING

IUCT Toulouse

Toulouse, France

NOT YET RECRUITING

MeSH Terms

Conditions

Chronic Pain

Interventions

ziconotide

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

CHEVALLIER Arthur

CONTACT

+33 (0)7 84 15 86 75; achevallier@esteve.com

Anne VISBECQ

CONTACT

anne.visbecq@yahoo.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 7, 2024
• Study Start: October 30, 2024
• Primary Completion (Estimated): October 30, 2029
• Study Completion (Estimated): October 30, 2029
• Last Updated: February 27, 2025

Record last verified: 2025-02

Locations

FR (14)