Nexstim has presented the final results of a multi-center Phase III trial in stroke rehabilitation (NICHE trial) assessing the company’s Navigated Brain Therapy system (NBT) at the International Stroke Conference in Houston, USA.
The presentation, by the trial Principal Investigator, Richard L. Harvey, MD, Rehabilitation Institute of Chicago, summarised the main safety and efficacy results of the NICHE trial, previously announced in March 2016.
The safety results were good with no serious adverse events (SAE) related to the use of Nexstim NBT® system. The primary outcome measure of significant clinical improvement of upper extremity motor function, defined as an increase of at least 5 points on the Upper Extremity Fugl-Meyer scale (UEFM) between baseline and six months after end of trial therapy, was reached by 67% of subjects in the active Nexstim NBT trial arm and 65% in the sham NBT trial arm. In the full trial population, the average improvement on UEFM was 8.2 points.
The secondary outcome measures including Action Research Arm Test; Wolf-Motor Function Test; Stroke Impact Scale; National Institute of Health Stroke Scale; Chedoke McMaster Stroke Assessment for Hand and Arm and the quality of life instrument ED-5Q, demonstrated a statistically significant improvement from baseline to 6 months after end of trial therapy in both trial arms (p<0.001 for each trial arm). As previously announced, the difference between trial arms was not statistically significant.
“The efficacy results obtained in NICHE show functional improvement in both trial arms. As previously announced by Nexstim, we believe the sham trial arm was not a true sham. Nexstim has now agreed a new 60 patient supplementary clinical trial with the FDA. We remain confident, given the results from the active arm of the NICHE study, that we can provide an important improvement in treatment for post-acute stroke patients as they undergo rehabilitation from this debilitating disease,” said Jarmo Laine, Vice President Medical Affairs.
In line with the FDA recommendation the data from the ongoing trial will be combined with data from the NICHE study in order to supplement the de novo 510(k) submission. Nexstim estimates it will receive efficacy results from the on-going 60 patient trial in Q1 2018. The combined results are then expected to be used to support a de novo 510(k) response in the summer or the fall of 2018. Clearance of this de novo 510(k) would allow Nexstim to start marketing and selling its NBT system for stroke rehabilitation in the USA.