Abstract Details

Title Office-Based Single-Shot Bolus Trial of Intrathecal Ziconotide in Patients with Painful Myelopathy and Neuropathy

Topic Ethics, Pain and Palliative Care

Presentation(s) P02 - (-)

Poster/Presentation
Number 009

Objective

Background BACKGROUND: Ziconotide is a intrathecal (IT), non-opiod, calcium channel inhibitor that blocks release of pain-associated neurotransmitters from primary afferent neurons. There are no studies assessing the response of neuropathic pain to ITZ via oupatient SST.

Design/Methods DESIGN/METHODS: IRB approved retrospective chart review of patients who underwent ITZ SST from 1/2010 to 4/2012. Brief Pain Inventory (BPI), Pain Numerical Rating Scale (P-NRS) and Center of Epidemiologic Depression Scale (CES-D) were recorded at baseline. Five mcg of ITZ in 1 mL saline was injected via lumbar puncture (LP). Patients already receiving IT bacofen for spasticity via a Synchromed II pump with refractory neuropathic pain, were trialed using catheter aspiration port technique (CAP). Hourly P-NRS were recorded. Patient Global Impression of Change (PGIC) was completed prior to clinic discharge. Return of pain was assessed via telephone followup.

Results RESULTS: Eleven patients underwent ITZ during the study period. Seven patients had painful myelopathy (4 MS, 2 TM, 1 NMO), 3 painful neuropathy (2 post-chemo, 1 CIDP) and 1 spastic CP. Baseline: Mean age 47.9±10.9 years, 82% Caucasian, 82% male, prior failed pain medications 3.7±1.2, P-NRS 7.4±2, BPI-severity 7.3±1.4, BPI-interference 5.9±3, BPI% pain improved on current therapies 29.2%±12.8, CES-D 10±8.1. Three patients had pre-existing IT baclofen pumps and underwent CAP instead of LP. P-NRS significantly improved from baseline 4 hours post-injection and continued to improve throughout trial duration. PGIC was also statistically significant. Adverse events: emesis and ataxia (n=1), urinary retention (n=2) urinary incontinence (n=1). Return of pain occurred at 25.5±14 hours.

Conclusions CONCLUSIONS: Preliminary data supports efficacy and safety of outpatient ITZ SST in medically refractory painful myelopathies and neuropathies. Use of CAP technique in patients who already have IT delivery systems. These results must be interpreted cautiously and replicated in a larger sample.

Authors/Disclosures
Jacqueline A. Nicholas, MD (OhioHealth Riverside Methodist Hospital) PRESENTER	Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol Myers Squib. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Greenwich Biosciences. Dr. Nicholas has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. Dr. Nicholas has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for EMD Serono. Dr. Nicholas has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Genentech. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Alexion. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Vielo Bio. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bristol Myers Squibb. The institution of Dr. Nicholas has received research support from Novartis. The institution of Dr. Nicholas has received research support from Biogen. The institution of Dr. Nicholas has received research support from Genentech. The institution of Dr. Nicholas has received research support from PCORI. Dr. Nicholas has a non-compensated relationship as a Physician with National MS Society that is relevant to AAN interests or activities. Dr. Nicholas has a non-compensated relationship as a Physician with Siegal Rare Neuroimmune Association that is relevant to AAN interests or activities.
	No disclosure on file
Victoria Lawson, MD, FAAN (Department of Neurology, Dartmouth-Hitchcock Medical Center)	Dr. Lawson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi.
Colleen M. O'Connell, CNP (Ohio State University Medical Center)	No disclosure on file
Aaron L. Boster, MD (Ohiohealth)	Dr. Boster has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for sanofi. Dr. Boster has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for roche. Dr. Boster has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for novartis. Dr. Boster has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medtronic. Dr. Boster has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Serono. The institution of Dr. Boster has received research support from Sanofi. The institution of Dr. Boster has received research support from Roche.
Michael H. Kohrman, MD	No disclosure on file

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