Using ziconotide for treating severe chronic pain not related to cancer

Ziconotide for Non-cancer Pain by Intrathecal Administration

This study is trying to see if ziconotide can safely help people with severe chronic pain that isn't related to cancer.

Quick facts

• Study type: Observational
• Enrollment: 85 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: ESTEVE Pharmaceuticals SAS (industry)
• Drugs / interventions: chemotherapy
• Locations: 14 sites (Aubagne and 13 other locations)
• Trial ID: NCT06541184 on ClinicalTrials.gov

What this trial studies

This observational registry aims to gather data on patients suffering from chronic non-cancer pain who are treated with ziconotide-based intrathecal analgesia. The study seeks to document the effectiveness and safety of ziconotide in this population, as its use has primarily been associated with cancer pain management. By collecting information from both current users of ziconotide and new candidates for treatment, the registry hopes to provide valuable insights that could guide future clinical decisions. The study addresses the gap in knowledge regarding the use of ziconotide for non-cancer pain, which is often overlooked due to a lack of comprehensive data.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older suffering from chronic non-cancer pain that requires interventional treatment.

Not a fit: Patients who have contraindications to intrathecal therapy or ziconotide, or those unable to participate in data collection, will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with severe chronic pain who have not responded to standard therapies.

How similar studies have performed: While ziconotide has been primarily studied in cancer pain, this approach for non-cancer pain is less documented, indicating a novel exploration in this area.

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.

Where this trial is running

Aubagne and 13 other locations

• 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)

Study contacts

• Study coordinator: CHEVALLIER Arthur

Conditions: Pain, Chronic, ziconotide, intrathecal analgesia, non-cancer pain, severe chronic pain