Ziconotide Bolus injections Study

• Research type

  Research Study

• Full title

  Intrathecal injection of a single dose of Ziconotide (Prialt®) to evaluate the option of continuous administration via implanted pump. A Pilot Study

• IRAS ID

  23726

• Eudract number

  2009-012928-89

• ISRCTN Number

  NA

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The administration of pain killer??s intra spinally (into the cerebro-spinaflud space in the spinal cord, (CSF) is a practice that has been used for 3 decades. The normal practice would be to administer the medication and find out if the pain is reduced, in a phase called a trial. If the trial is successful, the patient is then implanted with the permanent infusion pump. During the trial the pain killer is administered either by giving the patients a continuous infusion for a few weeks, or a one-off injection (bolus), the latter has been found to be cheaper, more convenient and carries less risk of serious infections such as meningitis. Studies conducted on Ziconotide infusions over six days via externalised catheters have shown an incidence of meningitis of 7%. We therefore feel that the administration of the drug Ziconotide by bolus for trial purposes has several advantages for patients and clinicians. We therefore aim to explore the efficacy and safety of boli of Ziconotide to evaluate the option of long term administration of the drug via an implanted pump. The study is a 2 centre non randomised, open- label pilot study of Ziconotide intrathecal boli as a trial prior to long term IT therapy with an implanted pump. We plan to administer 2 or 3 weekly sequential boli according to response. The bolus size will vary depending on the analgesics response or the side effects experienced. A good analgesic response with no side effects on two occasions will be considered as a successful trial. We will measure efficacy with pain measured on a 100mm line called the Visual analogue scale (VAS) and safety measured by recording vital signs and adverse events.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  09/H0907/59

• Date of REC Opinion

  15 Oct 2009

• REC opinion

  Further Information Favourable Opinion