Ziconotide as First-Line IDT

Neuropathic Pain Clinical Trial

Official title:

Prospective Study of Conservative Ziconotide Dosing as a First-Line Intrathecal Drug Therapy for Neuropathic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03321955
• Other study ID #: Jazz Prospective
• Status: Completed
• Phase: Phase 4
• Start date: November 3, 2016
• Est. completion date: December 30, 2020

Study information

• Verified date: January 2021
• Source: Albany Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 30, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Must be eligible for implantation of an intrathecal analgesia programmable pump system using ziconotide IT.

2. Must be 18 years of age or older for all points of data collection.

3. 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:

1. Must not have or been previously implanted with a programmable pump system.

2. Untreated mental illness including depression or anxiety determined by preoperative psychological evaluation.

3. Active substance abuse determined by preoperative urine drug screen.

4. Unwillingness to decrease oral medications at screening.

5. Any prior use of intrathecal analgesia besides trialing

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

Drug:
• Ziconotide 100 MCG(microgram)/ML Intrathecal Solution
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.

Diagnostic Test:
• Quantitative sensory testing
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 factor
Increases in these biomarkers indicate nerve pain as they are released from macrophages in patients with damaged nerves.

Locations

Country	Name	City	State
United States	Albany Medical College	Albany	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albany Medical College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline, 3, 4, 6, 8, 9, 10, 12 week and 4, 5, 6 and 12 months
Secondary	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.	Baseline, 12 weeks, 6 month, 12 month
Secondary	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.	Baseline, 12 weeks, 6 month
Secondary	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.	Baseline, 12 weeks, 6 month, 12 month
Secondary	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	Baseline, 12 weeks, 6 month, 12 month
Secondary	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.	Baseline, 12 weeks, 6 month, 12 month