Intrathecal Bolus Doses of Ziconotide
CompletedPhase 4NCT01373983
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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
- Conditions
- 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