March 2, 2016 — Nexstim Plc announced that the Data Safety Monitoring Board (DSMB), an independent committee of experts monitoring the Phase III stroke therapy NICHE trial, has reviewed the interim analysis data. The DSMB notes that the pre-specified stopping criteria for futility have been met and therefore the trial will not meet its primary endpoint. However, the DSMB further notes that they acknowledge that the treatments and enrolment have been completed. They recommend that the study team and subjects remain blinded and data collection be completed.
The second interim analysis on the NICHE (Navigated Inhibitory rTMS to Contralesional Hemisphere) trial using Nexstim’s Navigated Brain Therapy (NBT) was performed for 138 patients. Safety data was reviewed for all 199 patients recruited to-date; no safety concerns were observed.
Nexstim will analyze the DSMB recommendation further before deciding upon the continuation of the Phase III trial. With treatment on all patients now complete, the next phase of the trial would be to receive results from the third and final cohort’s six-month follow-up assessment.
Nexstim commenced the pivotal, randomized, sham-controlled, double-blinded multi-centre Phase III study in H1 2014 to demonstrate the effects of its NBT system on upper limb motor rehabilitation post-stroke. The two-year study is being conducted on up to 199 patients at 12 prominent rehabilitation sites in the United States. The primary objective of the study is to demonstrate a difference between the active NBT and sham groups of patients to achieve a clinically important functional improvement from baseline to six months post-treatment.
For more information: www.nexstim.com