Intrathecal Bolus Doses of Ziconotide

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Linkoeping
• Treatments: omega-Conotoxins; Ziconotide

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