NCT03321955

Ziconotide as First-Line IDT

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Albany Medical College · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neuropathic Pain

Interventions

Type	Name	Description
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,
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2016-11-03
• Primary completion: 2020-08-30
• Completion: 2020-12-30
• First posted: 2017-10-26
• Last updated: 2021-01-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study