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Intrathecal Bolus Doses of Ziconotide (ZicBol)

This study is currently recruiting participants.
Verified April 2011 by University Hospital, Linkoeping
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
History of Changes
  Purpose

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


Condition Intervention Phase
Peripheral Neuropathy
 Drug: Ziconotide
 Phase 4

Study Type: Interventional
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

Resource links provided by NLM:

Drug Information available for: Ziconotide
U.S. FDA Resources

Further study details as provided by University Hospital, Linkoeping:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 60
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)
Arms Assigned Interventions
ziconotide Drug: Ziconotide
1.25 or 2.5 mcg or 3.75 mcg i.t. according to an algorithm
Other Name: Prialt

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01373983

Contacts
Contact: Emmanuel Bäckryd, MD emmanuel.backryd@lio.se
Contact: Jan Sörensen, MD, PhD jan.sorensen@lio.se

Locations
Sweden
Pain and Rehabilitation Centre, University Hospital Recruiting
Linköping, Sweden, SE-581 85
Sponsors and Collaborators
University Hospital, Linkoeping
Investigators
Principal Investigator: Emmanuel Bäckryd, MD Pain and Rehabilitation Centre, University Hospital, Linköping, Sweden
  More Information

No publications provided

Responsible Party: Emmanuel Bäckryd, Pain and Rehabilitation Centre, University Hospital, Linköping, Sweden
ClinicalTrials.gov Identifier: NCT01373983     History of Changes
Other Study ID Numbers: EudraCT 2010-018920-21
Study First Received: May 25, 2011
Last Updated: November 13, 2012
Health Authority: Sweden: Medical Products Agency

Keywords provided by University Hospital, Linkoeping:
Neuropathic pain
Intrathecal analgesia
Ziconotide
Bolus
 trauma
central
severe
chronic

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Ziconotide
Omega-Conotoxins
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
 Therapeutic Uses
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Central Nervous System Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013