NCT04321408

Brief Summary

Ziconotide is a strong analgesic marketed since 2005 in Europe and reserved for the intrathecal route. Its efficacy has been proven in particular by 3 randomized clinical studies. It is particularly effective on neuropathic pain and its main advantages are its power of action, the absence of bone marrow toxicity, and the absence of respiratory depression. In addition, there were no signs of withdrawal when stopping the drug, or of tachyphylaxis. However, during these studies many adverse reactions were highlighted, especially neuropsychiatric which limited its use. This toxicity was mainly related to the administration of too high doses, especially at the start of treatment (too fast titration). In recent years, the use of intrathecal ziconotide has become a pertinent option. Indeed, it is recommended as first-line among the intrathecal treatment options. However, there is a lack of data on the current use of ziconotide in current practice. The objective of the study will be to describe the practical methods of using intrathecal treatments containing ziconotide.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
16mo left

Started Jul 2020

Longer than P75 for all trials

Geographic Reach
3 countries

17 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Jul 2020Sep 2027

First Submitted

Initial submission to the registry

March 23, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

July 10, 2020

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

August 17, 2025

Status Verified

July 1, 2025

Enrollment Period

7.1 years

First QC Date

March 23, 2020

Last Update Submit

August 13, 2025

Conditions

Refractory Pain

Keywords

Intrathecal analgesiaZiconotide

Outcome Measures

Primary Outcomes (1)

  • Describe the practical methods of using intrathecal treatments containing ziconotide: indication, initial intrathecal analgesic treatment and evolution of intrathecal analgesic treatment, efficacy and safety in the real clinical practice and monitoring.

    Indication, initial intrathecal analgesic treatment and evolution of intrathecal analgesic treatment and monitoring.

    7 years

Secondary Outcomes (6)

  • Describe the tolerability to intrathecal ziconotide treatment

    7 years

  • Describe the efficacy on pain of intrathecal ziconotide treatment

    7 years

  • Estimate the duration of treatment according to the indication

    7 years

  • Subgroup comparative analysis

    7 years

  • Responders profile detection

    7 years

  • +1 more secondary outcomes

Interventions

Ziconotide InjectionDRUG

Intrathecal analgesia with Ziconotide

Also known as: Prialt

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with refractory pain who is initiating treatment with intrathecal analgesia containing ziconotide.

You may qualify if:

  • Age ≥ 18 years old
  • Severe refractory chronic pain requiring intrathecal analgesia
  • Candidate for intrathecal analgesia treatment with ziconotide
  • Patient informed about the study and agreeing to take part in.

You may not qualify if:

  • Contraindications to ziconotide

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Institut de Cancerologie de L'Ouest

Angers, 49000, France

ACTIVE NOT RECRUITING

Centre Hospitalier Departemental La Roche Sur Yon

La Roche-sur-Yon, 85000, France

ACTIVE NOT RECRUITING

Centre Leon Berard

Lyon, 69008, France

ACTIVE NOT RECRUITING

Institut de Cancerologie de Montpellier

Montpellier, 34298, France

SUSPENDED

Clinique Breteche

Nantes, 44000, France

SUSPENDED

CHU NICE

Nice, 06003, France

SUSPENDED

Institut Curie

Saint-Cloud, 92210, France

SUSPENDED

Hopital - Foch

Suresnes, 92151, France

ACTIVE NOT RECRUITING

University of Freiburg

Freiburg im Breisgau, 79106, Germany

RECRUITING

Justus-Liebig-Universitat

Giessen, 353902, Germany

RECRUITING

Jena University Hospital

Jena, 07747, Germany

RECRUITING

Hospital Universitario Puerta Del Mar

Cadiz, 11009, Spain

RECRUITING

Hospital General Universitario Santa Lucía

Cartagena, 30202, Spain

RECRUITING

Hospital Universitario Virgen de las Nieves

Granada, 18014, Spain

RECRUITING

Hospital Complexo Hospitalario de Ourense

Ourense, 32005, Spain

RECRUITING

Hospital Universitario Virgen del Rocío

Seville, Spain

RECRUITING

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

RECRUITING

MeSH Terms

Conditions

Pain, Intractable

Interventions

ziconotide

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • DENIS DUPOIRON, MD

    Institut de Canérologie de l'Ouest

    STUDY DIRECTOR

Central Study Contacts

DENIS DUPOIRON, MD

CONTACT

+33 241352700denis.dupoiron@ico.unicancer.fr

MARINE TIGREAT

CONTACT

+33 240679878marine.tigreat@ico.unicancer.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2020

First Posted

March 25, 2020

Study Start

July 10, 2020

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

August 17, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(8)DE(3)ES(6)