Is a
Clinical Study attributes
NCT Number
Health Conditions in Trial
Trial Recruitment Size
130
Trial Sponsor
Clinical Trial Start Date
November 3, 2016
0Primary Completion Date
August 30, 2020
0Study Completion Date
December 30, 2020
0Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Diagnostic Test0
Drug0
Intervention Name
Quantitative sensory testing0
Ziconotide 100 MCG(microgram)/ML Intrathecal Solution0
Serum markers: Interleukin-1, Interleukin-6, and tumor necrosis factor0
Interventional Trial Phase
Phase 40
Participating Facility
Official Name
Prospective Study of Conservative Ziconotide Dosing as a First-Line Intrathecal Drug Therapy for Neuropathic Pain0
Last Updated
January 12, 2021
0Allocation Type
NA0
Intervention Model
Single Group Assignment0
Masking Type
None (Open Label)0
Study 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.
Timeline
No Timeline data yet.
Further Resources
No Further Resources data yet.
