Intrathecal Bolus Doses of Ziconotide

Study Overview
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Brief Summary
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The purpose of this study is to evaluate if the effect of ziconotide can be tested by intrathecal bolus doses.

Detailed Description
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The intrathecal route for administration of analgesia has been in use in clinical practice for the last 3 decades. It is recommended to trial the patient with intrathecal drug therapy prior to implanting an intrathecal drug delivery device. Trials can be performed using a single bolus injection or by a continuous intrathecal infusion administered through an external catheter. Ziconotide has been approved by EMA for the treatment of chronic severe pain in 2005. So far trials of ziconotide have largely been conducted using external catheters with the drug administered by intrathecal infusion over a number of weeks. Infusions trials have been shown to be expensive, associated with a risk of meningitis and inconvenient to both patient and physician. The option of conducting a trial of intrathecal ziconotide therapy by bolus injection remains unexplored. This study aims to evaluate the efficacy and safety of a bolus dose of ziconotide (Prialt®) to evaluate the option of continuous administration of the drug via implanted pump in the event of a successful trial.

Official Title
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Evaluation of a Structured Algorithm for Intrathecal Bolus Doses of Ziconotide (Prialt®)- The Swedish Ziconotide Bolus Study

Conditions
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Peripheral Neuropathy

Intervention / Treatment
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* Drug: Ziconotide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient, at least 18 years of age suffering from severe chronic (≥ 6 months) pain, who has failed on conventional pharmacological treatment only patients with peripheral neuropathic pain or central neuropathic pain, due to trauma or surgery, will be included Average usual VASPI last week ≥ 40 mm Patient capable of judgment, i.e. able to understand information regarding the drug, the mode of administration and evaluation of efficacy and side effects Signed informed consent Exclusion Criteria: Limited life expectancy (investigator's judgement) Intrathecal chemotherapy Known or suspected intracranial hypertension Known liver or kidney disease, defined as ASAT, ALAT, Total Bilirubin, ALP or S- Creatinine > 1.2 x ULN Advanced cardio-pulmonary disease (investigator's judgment) Ongoing infection, whether systemically or locally in the lumbar area Coagulopathy (including medication with warfarin, clopidogrel and heparin) Allergy to ziconotide or any of the excipients in the ziconotide vial History of psychiatric disorders which in the investigator's opinion would put the patient at risk Pregnant or lactating woman. Menstruating women must use an effective contraceptive method (contraceptive pill or intrauterine spiral) during the trial period

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ziconotide<br> | Drug: Ziconotide<br>* 1.25 or 2.5 mcg or 3.75 mcg i.t. according to an algorithm<br>* Other names: Prialt;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale Pain Intensity, VASPI, 0-100 mm | The average VASPI-score post-injection will be compared to the pre-injection value to yield a percentage pain reduction. Positive outcome is defined as a reduction of ≥30% in VASPI on two consecutive occasions at the same dosage without significant adverse events. All other cases will be considered as negative outcome. | VASPI before injection and then each hour after injection, for 6 hours. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuropathic pain, Intrathecal analgesia, Ziconotide, Bolus, trauma, central, severe, chronic