Intrathecal Bolus Doses of Ziconotide (ZicBol)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by University Hospital, Linkoeping.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Linkoeping
ClinicalTrials.gov Identifier:
NCT01373983
First received: May 25, 2011
Last updated: November 13, 2012
Last verified: April 2011

May 25, 2011
November 13, 2012
August 2011
September 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01373983 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Intrathecal Bolus Doses of Ziconotide
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.

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Peripheral Neuropathy
Drug: Ziconotide
1.25 or 2.5 mcg or 3.75 mcg i.t. according to an algorithm
Other Name: Prialt
ziconotide
Intervention: Drug: Ziconotide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
September 2014
September 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Emmanuel Bäckryd, MD emmanuel.backryd@lio.se
Contact: Jan Sörensen, MD, PhD jan.sorensen@lio.se
Sweden
 
NCT01373983
EudraCT 2010-018920-21
Yes
Emmanuel Bäckryd, Pain and Rehabilitation Centre, University Hospital, Linköping, Sweden
University Hospital, Linkoeping
Not Provided
Principal Investigator: Emmanuel Bäckryd, MD Pain and Rehabilitation Centre, University Hospital, Linköping, Sweden
University Hospital, Linkoeping
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP