Back to resultsZiconotide as First-Line IDT
Primary Purpose
Neuropathic Pain
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ziconotide 100 MCG(microgram)/ML Intrathecal Solution
Quantitative sensory testing
Serum markers: Interleukin-1, Interleukin-6, and tumor necrosis factor
Sponsored by
About this trial
This is an interventional treatment trial for Neuropathic Pain
Eligibility Criteria
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
Sites / Locations
- Albany Medical College
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Subjects with Painful Neuropathy
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
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.
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
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.
Full Information
NCT ID
NCT03321955
First Posted
October 19, 2017
Last Updated
January 11, 2021
Sponsor
Albany Medical College
1. Study Identification
Unique Protocol Identification Number
NCT03321955
Brief Title
Ziconotide as First-Line IDT
Official Title
Prospective Study of Conservative Ziconotide Dosing as a First-Line Intrathecal Drug Therapy for Neuropathic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 3, 2016 (Actual)
Primary Completion Date
August 30, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albany Medical College
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subjects with Painful Neuropathy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ziconotide 100 MCG(microgram)/ML Intrathecal Solution
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Quantitative sensory testing
Intervention Description
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,
Intervention Type
Diagnostic Test
Intervention Name(s)
Serum markers: Interleukin-1, Interleukin-6, and tumor necrosis factor
Intervention Description
Increases in these biomarkers indicate nerve pain as they are released from macrophages in patients with damaged nerves.
Primary Outcome Measure Information:
Title
Numerical Rating Scale (NRS)
Description
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
Time Frame
Baseline, 3, 4, 6, 8, 9, 10, 12 week and 4, 5, 6 and 12 months
Secondary Outcome Measure Information:
Title
Oswestry Disability Index Scale
Description
Comprises 11 sections, this survey asks the patient to indicate the degree to which they have difficulty in daily life relating to pain.
Time Frame
Baseline, 12 weeks, 6 month, 12 month
Title
SF (Short Form) - 36
Description
This scale utilizes 36 questions to determine overall quality of life in patients by discussing physical health, emotional health, and social engagement.
Time Frame
Baseline, 12 weeks, 6 month
Title
IADL(Instrumental Activities of Daily Living)
Description
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.
Time Frame
Baseline, 12 weeks, 6 month, 12 month
Title
Beck Depression Inventory
Description
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
Time Frame
Baseline, 12 weeks, 6 month, 12 month
Title
Pain Catastrophizing Scale
Description
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.
Time Frame
Baseline, 12 weeks, 6 month, 12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Ziconotide as First-Line IDT
We'll reach out to this number within 24 hrs