Intrathecal Bolus Doses of Ziconotide (ZicBol)

December 28, 2014 updated by: Emmanuel Backryd, University Hospital, Linkoeping

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Linköping, Sweden, SE-581 85
        • Pain and Rehabilitation Centre, University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: ziconotide
Drug: Ziconotide
1.25 or 2.5 mcg or 3.75 mcg i.t. according to an algorithm
Other Names:
  • Prialt

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale Pain Intensity, VASPI, 0-100 mm
Time Frame: VASPI before injection and then each hour after injection, for 6 hours.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Linkoeping

Investigators

  • Principal Investigator: Emmanuel Bäckryd, MD, Pain and Rehabilitation Centre, University Hospital, Linköping, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

May 25, 2011

First Submitted That Met QC Criteria

June 14, 2011

First Posted (ESTIMATE)

June 15, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

December 30, 2014

Last Update Submitted That Met QC Criteria

December 28, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EudraCT 2010-018920-21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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