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NCT Number: NCT04321408

OP2C : Prialt® Observatory in Clinical Practice

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.

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Key information

Conditions

Refractory Pain Neurologic Manifestations Pain Pain, Intractable Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut de Cancerologie de L'Ouest, Angers, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Contraindications to ziconotide

Treatment and study plan

Ziconotide Injection

Drug

Intrathecal analgesia with Ziconotide

Other names: Prialt

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.

    Time frame: 7 years

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

Secondary outcomes

  1. Describe the tolerability to intrathecal ziconotide treatment

    Time frame: 7 years

    Tolerability will be assessed by asking questions, clinical examination and paraclinical examinations at each visit

  2. Describe the efficacy on pain of intrathecal ziconotide treatment

    Time frame: 7 years

    The efficacy of the analgesic treatment is measured based on the numeric pain rating scale (0 to 10) at start of Ziconotide, 1, 3, 6, 12 months, and every 12 months thereafter

  3. Estimate the duration of treatment according to the indication

    Time frame: 7 years

    Time between the first and last date of administration of intrathecal ziconotide during study.

  4. Subgroup comparative analysis

    Time frame: 7 years

    Subgroup comparative analysis will be conducted according to initial characteristics, doses course progress of ziconotide and according to efficacy and tolerability.

  5. Responders profile detection

    Time frame: 7 years

    Responders profile according to efficacy on pain of intrathecal ziconotide treatment

  6. Describe quality of life under ziconotide treatment

    Time frame: 7 years

    f) The Quality of life will be assessed by EQ5D-5L questionnaires under intrathecal ziconotide treatment, at 1, 3, 6, 12 months, and every 12 months thereafter until the registry remains open

Study contacts

Contact information is provided by the study sponsor or research team.

DENIS DUPOIRON, MD

CONTACT

[email protected]

+33 241352700 ext. +33

MARINE TIGREAT

CONTACT

[email protected]

+33 240679878 ext. +33

Sponsors and collaborators

Lead sponsor

Institut Cancerologie de l'Ouest

Other

Collaborators

  • Esteve

Registry information

Acronym: OP2C

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Mar 25, 2020
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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