E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049475 |
E.1.2 | Term | Chronic pain |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of last subject undergoing the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |