Chronic pain MedDRA version: 12.1 Level: LLT Classification code 10049475 Term: Chronic pain
Conditions
Interventions
Trade Name: Prialt
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ZICONOTIDE
CAS Number: 107452-89-1
Other descriptive name: Prialt
Concentration unit: µg/ml microgram(s)/millilitre
Sponsors
Landstinget i Östergötland
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient, at least 18 years of age, suffering from severe chronic (=6 months) pain, e.g. peripheral neuropathic chronic non-malignant pain, failed back surgery syndrome etc. 2. Average usual VASPI last week = 40 mm 3. Patient capable of judgment, i.e. able to understand information regarding the drug, the mode of administration and evaluation of efficacy and side effects 4. Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Limited life expectancy (investigator’s judgement) 2. Intrathecal chemotherapy 3. Known or suspected intracranial hypertension 4. Advanced cardio-pulmonary disease (investigator’s judgment) 5. Ongoing infection, whether systemically or locally in the lumbar area 6. Coagulopathy (including medication with warfarin, clopidogrel and heparin) 7. Allergy to ziconotide or any of the excipients in the ziconotide vial 8. History of psychiatric disorders which in the investigator’s opinion would put the patient at risk 9. Pregnant or lactating woman 10. Participation in an other clinical trial during the last 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Open label non-randomised study aiming to evaluate the efficacy and safety of the administration of ziconotide by intrathecal boli on 3 consecutive occasions as a trial of intrathecal therapy. We aim to study a sample of 60 patients. The current VASPI (Visual Analogue Scale Pain Intensity, 0-100 mm) before each injection will be compared with the average of the VASPI scores registered hourly during the 6 hours following the injection. Moreover, the presence of any significant adverse event will be registered.;Secondary Objective: Proteomics analysis of a 10 mL sample of cerebrospinal fluid will be undertaken. The cerebrospinal fluid samples will be collected in connection with each injection. Proteomics enables the identification and quantification of thousands of proteins in one single analysis. Multivariate analysis will be used to evaluate changes in the pattern of proteomics over time. Based on this, individual proteins can be analyzed in more detail over time. ;Primary end point(s): Positive or negative outcome, see below, and at which dose. Descriptive statistics. 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. | — |
Countries
Sweden
Outcome results
None listed