Clinical trial · Interventional
Intrathecal Bolus Doses of Ziconotide
Evaluation of a Structured Algorithm for Intrathecal Bolus Doses of Ziconotide (Prialt®)- The Swedish Ziconotide Bolus Study
NCT01373983CI-TRIAL-00016470ZicBolcompletedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate if the effect of ziconotide can be tested by intrathecal bolus doses.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peripheral Neuropathy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ziconotide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- ziconotide
- interventionNames
- Drug: Ziconotide
Primary outcomes (1)
- measure
- Visual Analogue Scale Pain Intensity, VASPI, 0-100 mm
- timeFrame
- VASPI before injection and then each hour after injection, for 6 hours.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDJonsson M, Gerdle B, Ghafouri B, Backryd E. The inflammatory profile of cerebrospinal fluid, plasma, and saliva from patients with severe neuropathic pain and healthy controls-a pilot study. BMC Neurosci. 2021 Feb 1;22(1):6. doi: 10.1186/s12868-021-00608-5. PMID 33522900