Nalu Medical has announced the first patient enrolment in the COMFORT-2 randomised controlled trial (RCT), which will assess the company’s peripheral nerve stimulation (PNS) technologies. Together with COMFORT-1, COMFORT-2 is designed to enrol the largest cohort of RCT subjects comparing the responder rate of PNS combined with conventional medical management versus the responder rate of conventional medical management alone.
“I am thrilled to have enrolled the first patient in this important clinical trial. This is a significant milestone for our team and many clinicians who eagerly await empirical data to guide PNS treatment decisions,” said John Hatheway (Northwest Pain Care, Spokane, USA), who enrolled the first COMFORT-2 patient. “I am confident that this trial will provide valuable insights into the safety and efficacy of this innovative therapy, and I look forward to continuing to work with Nalu Medical to advance this programme and build Level 1 clinical evidence in the field of PNS.”
The COMFORT-2 RCT will enrol a maximum of 200 patients in up to 20 study centres in the USA. Subjects who have been diagnosed with peripheral neuralgia, mononeuropathy, neuropathic pain, or osteoarthritis pain in the low back, shoulder, knee or foot (including ankle), will be randomised to PNS combined with conventional treatments or conventional treatments alone.
The primary endpoints are responder rates at three months, as well as the rate of serious and non-serious adverse events. Secondary endpoints include responder rates, and the rate of serious and non-serious adverse events at six and 12 months, as well as patient-reported functional outcomes.
This is the second PNS RCT sponsored by Nalu Medical. An interim analysis of the COMFORT-1 study was presented earlier this year at the American Society of Interventional Pain Physicians (ASIPP) annual meeting (16–18 March, National Harbor, USA), with preliminary data demonstrating that 81% of patients in the treatment arm experienced ≥50% pain relief compared to 0% in the control arm. Additional COMFORT-1 interim analyses are set to be presented at the American Society of Pain and Neuroscience (ASPN) annual conference (13–16 July, Miami, USA).
A company press release details that the Nalu neurostimulation system for PNS is US Food and Drug Administration (FDA)-cleared for pain management in adults who have severe intractable chronic pain of peripheral nerve origin as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach.
It offers long-term pain relief with an FDA-cleared serviceable life of 18 years, incorporating a battery-free, micro-implantable pulse generator (micro-IPG) powered by an externally worn device (therapy disc) housing the battery and controller, the release adds.
“This milestone marks an important step in clinically validating the efficacy of the Nalu PNS system for the long-term treatment of chronic intractable peripheral neuralgia of post-traumatic or post-surgical origin,” said Tom West, Nalu Medical CEO and president. “We are proud to lead the charge in building scientific evidence for PNS while growing our portfolio of Nalu PNS clinical outcomes. We are committed to being the leader in PNS clinical data development.”