- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03321955
Ziconotide as First-Line IDT
January 11, 2021 updated by: Julie Pilitsis, MD, Albany Medical College
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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Albany, New York, United States, 12208
- Albany Medical College
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Subjects with Painful Neuropathy
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.
|
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 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,
Increases in these biomarkers indicate nerve pain as they are released from macrophages in patients with damaged nerves.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Baseline, 3, 4, 6, 8, 9, 10, 12 week and 4, 5, 6 and 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oswestry Disability Index Scale
Time Frame: Baseline, 12 weeks, 6 month, 12 month
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Comprises 11 sections, this survey asks the patient to indicate the degree to which they have difficulty in daily life relating to pain.
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Baseline, 12 weeks, 6 month, 12 month
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SF (Short Form) - 36
Time Frame: Baseline, 12 weeks, 6 month
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This scale utilizes 36 questions to determine overall quality of life in patients by discussing physical health, emotional health, and social engagement.
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Baseline, 12 weeks, 6 month
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IADL(Instrumental Activities of Daily Living)
Time Frame: Baseline, 12 weeks, 6 month, 12 month
|
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.
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Baseline, 12 weeks, 6 month, 12 month
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Beck Depression Inventory
Time Frame: Baseline, 12 weeks, 6 month, 12 month
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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
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Baseline, 12 weeks, 6 month, 12 month
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Pain Catastrophizing Scale
Time Frame: Baseline, 12 weeks, 6 month, 12 month
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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.
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Baseline, 12 weeks, 6 month, 12 month
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 3, 2016
Primary Completion (ACTUAL)
August 30, 2020
Study Completion (ACTUAL)
December 30, 2020
Study Registration Dates
First Submitted
October 19, 2017
First Submitted That Met QC Criteria
October 23, 2017
First Posted (ACTUAL)
October 26, 2017
Study Record Updates
Last Update Posted (ACTUAL)
January 12, 2021
Last Update Submitted That Met QC Criteria
January 11, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Neuralgia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Neuroprotective Agents
- Protective Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Ziconotide
Other Study ID Numbers
- Jazz Prospective
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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