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OP2C : Prialt® Observatory in Clinical Practice

ConditionRefractory Pain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitut Cancerologie de l'Ouest

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Contraindications to ziconotide

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Ziconotide Injection

    Drug

    Intrathecal analgesia with Ziconotide

Treatment groups

No treatment groups listed

Trial outcomes

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.

Time frame
7 years

Secondary outcomes

1

Describe the tolerability to intrathecal ziconotide treatment

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

Time frame
7 years
2

Describe the efficacy on pain of intrathecal ziconotide treatment

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

Time frame
7 years
3

Estimate the duration of treatment according to the indication

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

Time frame
7 years
4

Subgroup comparative analysis

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

Time frame
7 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institut Cancerologie de l'Ouest

Lead sponsor

Esteve

Collaborator

Source ClinicalTrials.gov
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