Neuropathic PainPhase 4NCT03321955
Ziconotide as First-Line IDT
A Phase 4 study testing Ziconotide 100 MCG(microgram)/ML Intrathecal Solution, Quantitative sensory testing and Serum markers: Interleukin-1, Interleukin-6, and tumor necrosis factor in people with Neuropathic Pain, run by Albany Medical College at 1 site in United States.
Trial summary
The primary objective of this study is to prospectively examine outcomes in 12 patients using ziconotide Intrathecal Drug Therapy(IDT) as first-line monotherapy with the use of an algorithm of slow titration for dosing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- Ziconotide 100 MCG(microgram)/ML Intrathecal Solution, Quantitative sensory testing and Serum markers: Interleukin-1, Interleukin-6, and tumor necrosis factor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2016to 30 Dec 2020
- 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
- Must be eligible for implantation of an intrathecal analgesia programmable pump system using ziconotide IT.
- Must be 18 years of age or older for all points of data collection.
- Must be diagnosed with neuropathic pain secondary to a clear etiology. Acceptable etiologies including but not limited to diabetic neuropathy, small fiber neuropathy, and post herpetic neuropathy.
Who cannot join
- Must not have or been previously implanted with a programmable pump system.
- Untreated mental illness including depression or anxiety determined by preoperative psychological evaluation.
- Active substance abuse determined by preoperative urine drug screen.
- Unwillingness to decrease oral medications at screening.
- Any prior use of intrathecal analgesia besides trialing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study of Conservative Ziconotide Dosing as a First-Line Intrathecal Drug Therapy for Neuropathic Pain
The primary objective of this study is to prospectively examine outcomes in 12 patients using ziconotide Intrathecal Drug Therapy(IDT) as first-line monotherapy with the use of an algorithm of slow titration for dosing. The use of Prialt has demonstrated fewer and less serious associated adverse effects as compared to IDT morphine, especially when titrated slowly. We will use an average Numerical Rating Scale as our primary outcome and the Oswestry Disability Index(ODI), Beck Depression Inventory (BDI), Pain Catastrophizing Scale (PCS), Clinical Global Impression of Change Scale including binary satisfaction measures(CGIC), Lawton-Brody Instrumental Activities of Daily Living(IADL) and Short Form-36 as secondary outcome measures.
- Conditions
- Neuropathic Pain
- Being tested
- Ziconotide 100 MCG(microgram)/ML Intrathecal Solution, Quantitative sensory testing, Serum markers: Interleukin-1, Interleukin-6, and tumor necrosis factor
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ziconotide 100 MCG(microgram)/ML Intrathecal SolutionDrug
Initial dose at time of the implant will be 1.2 mcg/day with dose increases of no more the .4 mcg/day planned for 3, 6, 8, 9, 10, 12 weeks and 4, 5, 6 and 12 months.
Quantitative sensory testingDiagnostic test
Quantitative sensory testing will be done using different types of sensory stimulation to objectively quantify sensation and pain tolerance. VonFrey fibers of various widths are used to detect sensation, a Neuropen pin prick iutilized to detect pain, along with a tuning fork to measure vibrationand a pressure guage to measure pressure felt on the skin. Cold/hot sensation is tested with Medoc Pathway system to quantitatively measure the temperature felt by patients to be done at baseline, 6 months and 12 months,
Serum markers: Interleukin-1, Interleukin-6, and tumor necrosis factorDiagnostic test
Increases in these biomarkers indicate nerve pain as they are released from macrophages in patients with damaged nerves.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with Painful Neuropathy | Experimental | All subjects will be implanted with the Medtronic Synchromed II pump, and treated with the same algorithm for dose adjustment for painful neuropathy with Ziconotide 100 micrograms/ml. Receives: Drug: Ziconotide 100 MCG(microgram)/ML Intrathecal Solution; Diagnostic Test: Quantitative sensory testing; Diagnostic Test: Serum markers: Interleukin-1, Interleukin-6, and tumor necrosis factor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale (NRS)
This scale allows the subject to quantify their pain numerically, with 10 being the worst pain imaginable. This scale describe subject reported pain at its worst and best in the week prior to reporting, as well as total pain on average, and at the time of documentation. The mean of these scores will be used as the primary outcome. This scale also includes a question of subject experienced global improvement in which the patient is asked to quantify their overall change in pain with 0 being no change and 10 being completely changed. Using the NRS we will calculate a responder rate, assessing percentage of patients with a 50% response in NRS
Measured: Baseline, 3, 4, 6, 8, 9, 10, 12 week and 4, 5, 6 and 12 months
Secondary outcomes (5)
Oswestry Disability Index Scale
Comprises 11 sections, this survey asks the patient to indicate the degree to which they have difficulty in daily life relating to pain.
Measured: Baseline, 12 weeks, 6 month, 12 month
SF (Short Form) - 36
This scale utilizes 36 questions to determine overall quality of life in patients by discussing physical health, emotional health, and social engagement.
Measured: Baseline, 12 weeks, 6 month
IADL(Instrumental Activities of Daily Living)
Used to assess complex functional activities of daily living, this scale extrapolates on basic activities such as ability to eat or walk, to include cooking shopping, housekeeping.
Measured: Baseline, 12 weeks, 6 month, 12 month
Beck Depression Inventory
21 question survey pertaining to a patient's severity of depression. Each question is scored for 0 to 3, with 0 indicating no depression and 3 indicating the most severe depression
Measured: Baseline, 12 weeks, 6 month, 12 month
Pain Catastrophizing Scale
This scale separates three types of catastrophizing: rumination, magnification and helplessness. Catastrophic thinking can contribute to the probability that a pain condition will be persistent over tim.
Measured: Baseline, 12 weeks, 6 month, 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start3 Nov 2016
- Primary completion30 Aug 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albany Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Pilitsis, MD, Albany Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03321955
- Sponsor's protocol ID
- Jazz Prospective
- Status last verified
- Jan 2021
- First submitted
- 19 Oct 2017
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Conservative Ziconotide Dosing as a First-Line Intrathecal Drug Therapy for Neuropathic Pain
- ClinicalTrials.gov ID
- NCT03321955
- Acronym / sponsor ID
- Jazz Prospective
- Conditions
- Neuropathic Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Albany Medical CollegeUniversity, hospital or other
- Study start
- 3 Nov 2016 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 26 Oct 2017 (actual)
- 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 primary objective of this study is to prospectively examine outcomes in 12 patients using ziconotide Intrathecal Drug Therapy(IDT) as first-line monotherapy with the use of an algorithm of slow titration for dosing. The use of Prialt has demonstrated fewer and less serious associated adverse effects as compared to IDT morphine, especially when titrated slowly. We will use an average Numerical Rating Scale as our primary outcome and the Oswestry Disability Index(ODI), Beck Depression Inventory (BDI), Pain Catastrophizing Scale (PCS), Clinical Global Impression of Change Scale including binary satisfaction measures(CGIC), Lawton-Brody Instrumental Activities of Daily Living(IADL) and Short Form-36 as secondary outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with Painful Neuropathy | Experimental | Drug: Ziconotide 100 MCG(microgram)/ML Intrathecal Solution, Diagnostic Test: Quantitative sensory testing, Diagnostic Test: Serum markers: Interleukin-1, Interleukin-6, and tumor necrosis factorAll subjects will be implanted with the Medtronic Synchromed II pump, and treated with the same algorithm for dose adjustment for painful neuropathy with Ziconotide 100 micrograms/ml. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must be eligible for implantation of an intrathecal analgesia programmable pump system using ziconotide IT.
- Must be 18 years of age or older for all points of data collection.
- Must be diagnosed with neuropathic pain secondary to a clear etiology. Acceptable etiologies including but not limited to diabetic neuropathy, small fiber neuropathy, and post herpetic neuropathy.
Key exclusion criteria (5 listed)
- Must not have or been previously implanted with a programmable pump system.
- Untreated mental illness including depression or anxiety determined by preoperative psychological evaluation.
- Active substance abuse determined by preoperative urine drug screen.
- Unwillingness to decrease oral medications at screening.
- Any prior use of intrathecal analgesia besides trialing
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 |
|---|---|---|
| Ziconotide 100 MCG(microgram)/ML Intrathecal SolutionInitial dose at time of the implant will be 1.2 mcg/day with dose increases of no more the .4 mcg/day planned for 3, 6, 8, 9, 10, 12 weeks and 4, 5, 6 and 12 months. | Drug | Subjects with Painful Neuropathy |
| Quantitative sensory testingQuantitative sensory testing will be done using different types of sensory stimulation to objectively quantify sensation and pain tolerance. VonFrey fibers of various widths are used to detect sensation, a Neuropen pin prick iutilized to detect pain, along with a tuning fork to measure vibrationand a pressure guage to measure pressure felt on the skin. Cold/hot sensation is tested with Medoc Pathway system to quantitatively measure the temperature felt by patients to be done at baseline, 6 months and 12 months, | Diagnostic test | Subjects with Painful Neuropathy |
| Serum markers: Interleukin-1, Interleukin-6, and tumor necrosis factorIncreases in these biomarkers indicate nerve pain as they are released from macrophages in patients with damaged nerves. | Diagnostic test | Subjects with Painful Neuropathy |
Primary outcome
Numerical Rating Scale (NRS)
Time frame: Baseline, 3, 4, 6, 8, 9, 10, 12 week and 4, 5, 6 and 12 months
This scale allows the subject to quantify their pain numerically, with 10 being the worst pain imaginable. This scale describe subject reported pain at its worst and best in the week prior to reporting, as well as total pain on average, and at the time of documentation. The mean of these scores will be used as the primary outcome. This scale also includes a question of subject experienced global improvement in which the patient is asked to quantify their overall change in pain with 0 being no change and 10 being completely changed. Using the NRS we will calculate a responder rate, assessing percentage of patients with a 50% response in NRS
5 secondary outcomes
Oswestry Disability Index Scale
Time frame: Baseline, 12 weeks, 6 month, 12 month
SF (Short Form) - 36
Time frame: Baseline, 12 weeks, 6 month
IADL(Instrumental Activities of Daily Living)
Time frame: Baseline, 12 weeks, 6 month, 12 month
Beck Depression Inventory
Time frame: Baseline, 12 weeks, 6 month, 12 month
Pain Catastrophizing Scale
Time frame: Baseline, 12 weeks, 6 month, 12 month
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 12 Jan 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 100 MCG(microgram)/ML Intrathecal Solution, Quantitative sensory testing and Serum markers: Interleukin-1, Interleukin-6, and tumor necrosis factor in people with Neuropathic Pain, run by Albany Medical College at 1 site in United States.
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 3 inclusion and 5 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 12 Jan 2021. 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 United States. 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?
Numerical Rating Scale (NRS) (time frame: Baseline, 3, 4, 6, 8, 9, 10, 12 week and 4, 5, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2021.