Ziconotide as First-Line IDT

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

Sponsors

Lead Sponsor: Albany Medical College

Source Albany Medical College
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.

Overall Status Completed
Start Date 2016-11-03
Completion Date 2020-12-30
Primary Completion Date 2020-08-30
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Numerical Rating Scale (NRS) Baseline, 3, 4, 6, 8, 9, 10, 12 week and 4, 5, 6 and 12 months
Secondary Outcome
Measure Time Frame
Oswestry Disability Index Scale Baseline, 12 weeks, 6 month, 12 month
SF (Short Form) - 36 Baseline, 12 weeks, 6 month
IADL(Instrumental Activities of Daily Living) Baseline, 12 weeks, 6 month, 12 month
Beck Depression Inventory Baseline, 12 weeks, 6 month, 12 month
Pain Catastrophizing Scale Baseline, 12 weeks, 6 month, 12 month
Enrollment 13
Condition
Intervention

Intervention Type: Drug

Intervention Name: Ziconotide 100 MCG(microgram)/ML Intrathecal Solution

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.

Arm Group Label: Subjects with Painful Neuropathy

Intervention Type: Diagnostic Test

Intervention Name: Quantitative sensory testing

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,

Arm Group Label: Subjects with Painful Neuropathy

Intervention Type: Diagnostic Test

Intervention Name: Serum markers: Interleukin-1, Interleukin-6, and tumor necrosis factor

Description: Increases in these biomarkers indicate nerve pain as they are released from macrophages in patients with damaged nerves.

Arm Group Label: Subjects with Painful Neuropathy

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Location
Facility: Albany Medical College
Location Countries

United States

Verification Date

2021-01-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Albany Medical College

Investigator Full Name: Julie Pilitsis, MD

Investigator Title: MD

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Subjects with Painful Neuropathy

Type: Experimental

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.

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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