Ziconotide as First-Line IDT

PHASE4CompletedINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

November 3, 2016

Primary Completion Date

August 30, 2020

Study Completion Date

December 30, 2020

Conditions
Neuropathic Pain
Interventions
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.

Trial Locations (1)

12208

Albany Medical College, Albany

Sponsors
All Listed Sponsors
lead

Albany Medical College

OTHER