Peripheral NeuropathyPhase 4ZicBolNCT01373983
Intrathecal Bolus Doses of Ziconotide
A Phase 4 study testing Ziconotide in people with Peripheral Neuropathy, run by University Hospital, Linkoeping at 1 site in Sweden.
Trial summary
The purpose of this study is to evaluate if the effect of ziconotide can be tested by intrathecal bolus doses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Neuropathy
- What is being tested?
- Ziconotide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2011to Dec 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Pain and Rehabilitation Centre, University Hospital
Linköping, SE-581 85
About this study
Official title: Evaluation of a Structured Algorithm for Intrathecal Bolus Doses of Ziconotide (Prialt®)- The Swedish Ziconotide Bolus Study
The purpose of this study is to evaluate if the effect of ziconotide can be tested by intrathecal bolus doses.
Read the detailed description
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.
- Conditions
- Peripheral Neuropathy
- Being tested
- Ziconotide
- Keywords
- Neuropathic pain, Intrathecal analgesia, Ziconotide, Bolus, trauma, central, severe, chronic
- Medical subject headings
- Peripheral Nervous System Diseases, Neuralgia, Wounds and Injuries, Lymphoma, Follicular, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZiconotideDrug
Also called Prialt
1.25 or 2.5 mcg or 3.75 mcg i.t. according to an algorithm
| Study group | Role | What they receive |
|---|---|---|
| ziconotide | Other | Not described Receives: Drug: Ziconotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: VASPI before injection and then each hour after injection, for 6 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emmanuel Backryd, University Hospital, Linkoeping
- Investigators
- Emmanuel Bäckryd, MD, Principal investigator, Pain and Rehabilitation Centre, University Hospital, Linköping, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01373983
- Sponsor's protocol ID
- EudraCT 2010-018920-21
- Acronym
- ZicBol
- Status last verified
- Dec 2014
- First submitted
- 25 May 2011
- Last updated
- 30 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33522900
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Structured Algorithm for Intrathecal Bolus Doses of Ziconotide (Prialt®)- The Swedish Ziconotide Bolus Study
- ClinicalTrials.gov ID
- NCT01373983
- Acronym / sponsor ID
- ZicBol / EudraCT 2010-018920-21
- Conditions
- Peripheral Neuropathy
- Keywords
- Neuropathic pain, Intrathecal analgesia, Ziconotide, Bolus, trauma, central, severe, chronic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 15 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate if the effect of ziconotide can be tested by intrathecal bolus doses.
Detailed description
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ziconotide | Other | Drug: Ziconotide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZiconotideAlso: Prialt1.25 or 2.5 mcg or 3.75 mcg i.t. according to an algorithm | Drug | ziconotide |
Primary outcome
Visual Analogue Scale Pain Intensity, VASPI, 0-100 mm
Time frame: VASPI before injection and then each hour after injection, for 6 hours.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2014.
- Derived from this study: PubMed 33522900Jonsson 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel Bäckryd, MD principal investigator
Pain and Rehabilitation Centre, University Hospital, Linköping, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ziconotide in people with Peripheral Neuropathy, run by University Hospital, Linkoeping at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale Pain Intensity, VASPI, 0-100 mm (time frame: VASPI before injection and then each hour after injection, for 6 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01373983, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2014.