Intrathecal Bolus Doses of Ziconotide (ZicBol)
The purpose of this study is to evaluate if the effect of ziconotide can be tested by intrathecal bolus doses.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Evaluation of a Structured Algorithm for Intrathecal Bolus Doses of Ziconotide (Prialt®)- The Swedish Ziconotide Bolus Study|
- Visual Analogue Scale Pain Intensity, VASPI, 0-100 mm [ Time Frame: VASPI before injection and then each hour after injection, for 6 hours. ] [ Designated as safety issue: No ]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.
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
1.25 or 2.5 mcg or 3.75 mcg i.t. according to an algorithm
Other Name: Prialt
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.
|Contact: Emmanuel Bäckryd, MDfirstname.lastname@example.org|
|Contact: Jan Sörensen, MD, PhDemail@example.com|
|Pain and Rehabilitation Centre, University Hospital||Recruiting|
|Linköping, Sweden, SE-581 85|
|Principal Investigator:||Emmanuel Bäckryd, MD||Pain and Rehabilitation Centre, University Hospital, Linköping, Sweden|