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Intrathecal Bolus Doses of Ziconotide

CompletedPhase 4NCT01373983
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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

Study details

Official title
Evaluation of a Structured Algorithm for Intrathecal Bolus Doses of Ziconotide (Prialt®)- The Swedish Ziconotide Bolus Study
Interventions
Sponsor
University Hospital, Linkoeping
Start date
2011-08
Primary completion
2014-12
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
Sweden
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01373983