Just two months after announcing what it claims is the “world’s first positive surgical trial” in haemorrhagic stroke, NICO Corporation is awarding a US$200,000 investigator-initiated study grant with the goal of building on conclusions from the ENRICH study and further improving patient outcomes in this space.
ENRICH-PLUS—a sub-study of ENRICH—will examine the safety and suitability of supplementing early minimally invasive parafascicular surgery (MIPS) for clot evacuation of basal ganglia intracerebral haemorrhage (ICH), using NICO technologies, with Takeda Pharmaceutical’s US Food and Drug Administration (FDA)-approved diabetes drug pioglitazone.
A NICO press release notes that several preclinical studies have shown that pioglitazone can reduce blood toxicity and accelerate removal of blood, but it has never been evaluated for use in combination with surgical evacuation of stroke during neurosurgery.
“Initial evidence from preclinical studies has led us to believe that patients who undergo early MIPS to remove a blood clot and then receive pioglitazone may have more rapid resolution of any residual blood in the brain, less inflammation and less cell death, which together may lead to improved patient outcomes. The goal of our study is to evaluate that hypothesis,” said Marc Simard (University of Maryland School of Medicine, Baltimore, USA), who will lead the non-randomised controlled study.
The results of the recently completed ENRICH trial, sponsored by NICO, are “revolutionary”, the release continues, adding that it produced Level 1 evidence indicating that MIPS patients achieved a statistically significant and clinically meaningful improvement with early surgical intervention for spontaneous ICH versus medical management.
ENRICH-PLUS will take 20 MIPS basal ganglia subjects from the initial ENRICH study group, and enrol 20 new patients presenting with approximately the same size, location and type of ICH, who will receive pioglitazone. The study will follow the same protocols as ENRICH and evaluate the same surgical outcomes using NICO technologies, in addition to assessing pioglitazone’s impact on functional recovery from the historical group to the new patient group—as measured by utility-weighted modified Rankin scale (mRS) scores at 180 days.
“The ENRICH trial outcomes gave us tremendous momentum in surgically treating patients with ICH and are changing the traditional medical management course of patient treatment,” said Jim Pearson, NICO’s president and CEO. “But, the effects of brain swelling cause significant slowing of functional recovery and sometimes even death. We are optimistic that the addition of a neuroprotectant as part of the ENRICH-PLUS study will further improve functional recovery.”
Simard added that now is the time to “advance the great promise of MIPS in ICH by proceeding with the ENRICH-PLUS trial”, the release also relays.