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The purpose of this study is to evaluate if the effect of ziconotide can be tested by intrathecal bolus doses.
The intrathecal route for administration of analgesia has been in use in clinical practice for the last 3 decades. It is recommended to trial the patient with intrathecal drug therapy prior to implanting an intrathecal drug delivery device. Trials can be performed using a single bolus injection or by a continuous intrathecal infusion administered through an external catheter. Ziconotide has been approved by EMA for the treatment of chronic severe pain in 2005. So far trials of ziconotide have largely been conducted using external catheters with the drug administered by intrathecal infusion over a number of weeks. Infusions trials have been shown to be expensive, associated with a risk of meningitis and inconvenient to both patient and physician. The option of conducting a trial of intrathecal ziconotide therapy by bolus injection remains unexplored.
This study aims to evaluate the efficacy and safety of a bolus dose of ziconotide (Prialt®) to evaluate the option of continuous administration of the drug via implanted pump in the event of a successful trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ziconotide | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ziconotide | Drug | 1.25 or 2.5 mcg or 3.75 mcg i.t. according to an algorithm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale Pain Intensity, VASPI, 0-100 mm | 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. | VASPI before injection and then each hour after injection, for 6 hours. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emmanuel Bäckryd, MD | Pain and Rehabilitation Centre, University Hospital, Linköping, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pain and Rehabilitation Centre, University Hospital | Linköping | SE-581 85 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33522900 | Derived | Jonsson 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. |
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| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009437 | Neuralgia |
| D014947 | Wounds and Injuries |
| D008224 | Lymphoma, Follicular |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| C078452 | ziconotide |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |