Start-up to evaluate migraine therapy for pre-menopausal women

A US clinical-stage medical device company is to conduct a clinical study to evaluate the efficacy of its “innovative” migraine therapy.

ShiraTronics’ system claims to deliver electrical pulses tailored to disrupt migraine pain signals. The device aims to offer patients and physicians a novel and potentially more effective treatment option.

Migraine, recognised globally as a significant cause of disability, particularly among pre-menopausal women, poses a substantial health challenge.

For around two per cent of the world’s population, migraine headaches escalate to chronic attacks, leading to debilitating symptoms such as intense headaches, nausea, and sensitivity to light for a minimum of 15 days each month.

ShiraTronics promises to address these symptoms. The company, which has completed the enrolment in its pilot study for its migraine therapy, prepares for a “pivotal” clinical study.

The RELIEV-CM pilot study, conducted at five centres in collaboration with leading Australian neurology and pain management researchers, will evaluate the performance of the ShiraTronics System.

According to the Brooklyn Park-based start-up, the study has already yielded encouraging early data on the potential efficacy of the migraine solution, suggesting promising results indicating a decrease in both headache and migraine days, as well as reductions in headache duration and severity.

Preliminary outcomes, ShiraTronics says, have demonstrated meaningful headache day reduction after four weeks of therapy and completion of a 28-day headache diary.

Dr Brian Grosberg, director of the Hartford Healthcare Headache Program in Connecticut and professor of neurology at the University of Connecticut School of Medicine, said: “The positive results from the Australian pilot study indicate the potential impact of ShiraTronics’ treatment on chronic migraine sufferers.

“I am excited to co-lead the pivotal clinical study advancing migraine treatment options and further explore the benefits this technology could offer to patients dealing with chronic migraine.”

Fred Ecklund, ShiraTronics vice president of global clinical affairs, said: “We are grateful to our dedicated investigators and patients whose invaluable contributions have propelled our research forward.

“As we embark on the next phase of clinical trials with our upcoming pivotal study, we eagerly anticipate continued partnerships that will help us make meaningful strides in advancing therapy options for these patients.”

Dr Samer Narouze, an expert consultant in headaches and pain medicine and chairman of the Center for Pain Medicine at Western Reserve Hospital in Cuyahoga Falls, Ohio, added: “I would like to congratulate the ShiraTronics team on their groundbreaking research.

“This pilot study is truly commendable and is poised to make a substantial contribution to ShiraTronics’ future research as they continue to strive to address the unmet needs of chronic migraine patients.”