Intrathecal Bolus Doses of Ziconotide

Peripheral Neuropathy Clinical Trial

— ZicBol  

Official title:

Evaluation of a Structured Algorithm for Intrathecal Bolus Doses of Ziconotide (Prialt®)- The Swedish Ziconotide Bolus Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01373983
• Other study ID #: EudraCT 2010-018920-21
• Status: Completed
• Phase: Phase 4
• First received: May 25, 2011
• Last updated: December 28, 2014
• Start date: August 2011
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

Drug:
• Ziconotide
1.25 or 2.5 mcg or 3.75 mcg i.t. according to an algorithm

Locations

Country	Name	City	State
Sweden	Pain and Rehabilitation Centre, University Hospital	Linköping

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale Pain Intensity, VASPI, 0-100 mm	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.	No