Peripheral Neuropathy Clinical Trial
Official title:
Evaluation of a Structured Algorithm for Intrathecal Bolus Doses of Ziconotide (Prialt®)- The Swedish Ziconotide Bolus Study
The purpose of this study is to evaluate if the effect of ziconotide can be tested by intrathecal bolus doses.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
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