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Intrathecal Bolus Doses of Ziconotide (ZicBol)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01373983
Recruitment Status : Completed
First Posted : June 15, 2011
Last Update Posted : December 30, 2014
Information provided by (Responsible Party):
Emmanuel Backryd, University Hospital, Linkoeping

Brief Summary:
The purpose of this study is to evaluate if the effect of ziconotide can be tested by intrathecal bolus doses.

Condition or disease Intervention/treatment Phase
Peripheral Neuropathy Drug: Ziconotide Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Evaluation of a Structured Algorithm for Intrathecal Bolus Doses of Ziconotide (Prialt®)- The Swedish Ziconotide Bolus Study
Study Start Date : August 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Ziconotide

Arm Intervention/treatment
ziconotide Drug: Ziconotide
1.25 or 2.5 mcg or 3.75 mcg i.t. according to an algorithm
Other Name: Prialt

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01373983

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Pain and Rehabilitation Centre, University Hospital
Linköping, Sweden, SE-581 85
Sponsors and Collaborators
University Hospital, Linkoeping
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Principal Investigator: Emmanuel Bäckryd, MD Pain and Rehabilitation Centre, University Hospital, Linköping, Sweden
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Responsible Party: Emmanuel Backryd, Seniro Consultant in Pain management, University Hospital, Linkoeping Identifier: NCT01373983    
Other Study ID Numbers: EudraCT 2010-018920-21
First Posted: June 15, 2011    Key Record Dates
Last Update Posted: December 30, 2014
Last Verified: December 2014
Keywords provided by Emmanuel Backryd, University Hospital, Linkoeping:
Neuropathic pain
Intrathecal analgesia
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents