Gladstone C McDowell, II, MD, Michael F Saulino, MD, PhD, Mark Wallace, MD, Eric J Grigsby, MD, Richard L Rauck, MD, Philip Kim, MD, Geertrui F Vanhove, MD, PhD, Robert Ryan, MS, I-Zu Huang, MD, Timothy Deer, MD
Background and Objectives
The Patient Registry of Intrathecal Ziconotide Management evaluated the long-term effectiveness and safety of intrathecal ziconotide.
Methods
The study was a prospective, multicenter observational study of intrathecal ziconotide in US clinical practice. Patients were adults with severe chronic pain that warranted intrathecal therapy. Ziconotide was initiated as the single agent in the pump; however, other intrathecal medications were permitted. The primary efficacy outcome was ≥30% reduction in numeric pain rating scale score from baseline at week 12. A secondary outcome was patient global impression of change. Adverse events were solicited at each visit.